Clinical Trials /

Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma

NCT03696784

Description:

This research study combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This study combines both T cells and antibodies to create a more effective treatment. The treatment being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD19 antigen (ATLCAR.CD19) administration. Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD19. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD19 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown. Preliminary results have shown that subjects receiving this treatment have experienced unwanted side effects including cytokine release syndrome and neurotoxocity. In this study, to help reduce cytokine release syndrome and/or neurotoxicity symptoms, the ATLCAR.CD19 cells have a safety switch that, when active, can cause the cells to become dormant. These modified ATLCAR.CD19 cells with the safety switch are referred to as iC9-CAR19 cells. If the subject experiences moderate to severe cytokine release syndrome and or neurotoxicity as a result of being given iC9-CAR19 cells, the subject can be given a dose of a second study drug, AP1903, if standard interventions fail to alleviate the symptoms of cytokine release syndrome and/or neurotoxicity. AP1903 activates the iC9-CAR19 safety switch, reducing the number of the iC9-CAR19 cells in the blood. The ultimate goal is to determine what dose of AP1903 can be given that reduces the severity of the cytokine release syndrome and/or neurotoxicity, but still allows the remaining iC9-CAR19 cells to effectively fight the lymphoma. The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable in patients with relapsed/refractory B-cell lymphoma.

Related Conditions:
  • B-Cell Lymphoma, Unclassifiable, with Features Intermediate between Diffuse Large B-Cell Lymphoma and Classical Hodgkin Lymphoma
  • B-Cell Non-Hodgkin Lymphoma
  • Diffuse Large B-Cell Lymphoma Associated with Chronic Inflammation
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Double-Hit Lymphoma
  • Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Follicular Lymphoma
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Intravascular Large B-Cell Lymphoma
  • Lymphomatoid Granulomatosis
  • Mantle Cell Lymphoma
  • Mediastinal Large B-Cell Lymphoma
  • Nodal Marginal Zone Lymphoma
  • Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
  • Splenic Marginal Zone Lymphoma
  • T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Transformed Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma
  • Official Title: A Phase I Study of Autologous Activated T-cells Targeting the CD19 Antigen and Containing the Inducible Caspase 9 Safety Switch in Subjects With Relapsed/Refractory B-cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: LCCC 1813-ATL
  • NCT ID: NCT03696784

Conditions

  • Lymphoma
  • Lymphoma, B-Cell
  • Immune System Diseases
  • Immunoproliferative Disorders
  • Lymphatic Diseases

Interventions

DrugSynonymsArms
iC9-CAR19 T cellsSingle Arm iC9.CAR19 T cells
BendamustineTreanda, BendekaSingle Arm iC9.CAR19 T cells
FludarabineFludaraSingle Arm iC9.CAR19 T cells
AP1903RimiducidSingle Arm iC9.CAR19 T cells

Purpose

This research study combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This study combines both T cells and antibodies to create a more effective treatment. The treatment being researched is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD19 antigen (ATLCAR.CD19) administration. Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD19. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD19 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown. Preliminary results have shown that subjects receiving this treatment have experienced unwanted side effects including cytokine release syndrome and neurotoxocity. In this study, to help reduce cytokine release syndrome and/or neurotoxicity symptoms, the ATLCAR.CD19 cells have a safety switch that, when active, can cause the cells to become dormant. These modified ATLCAR.CD19 cells with the safety switch are referred to as iC9-CAR19 cells. If the subject experiences moderate to severe cytokine release syndrome and or neurotoxicity as a result of being given iC9-CAR19 cells, the subject can be given a dose of a second study drug, AP1903, if standard interventions fail to alleviate the symptoms of cytokine release syndrome and/or neurotoxicity. AP1903 activates the iC9-CAR19 safety switch, reducing the number of the iC9-CAR19 cells in the blood. The ultimate goal is to determine what dose of AP1903 can be given that reduces the severity of the cytokine release syndrome and/or neurotoxicity, but still allows the remaining iC9-CAR19 cells to effectively fight the lymphoma. The primary purpose of this study is to determine whether receiving iC9-CAR19 cells is safe and tolerable in patients with relapsed/refractory B-cell lymphoma.

Detailed Description

      This study is a phase I dose finding trial to determine if chimeric antigen receptor T
      (CAR-T) cells targeting the CD19 antigen and containing the inducible caspase 9 safety switch
      can be safely administered to adult subjects with relapsed or refractory B-cell Lymphoma. The
      safety of iC9-CAR19 cells will be investigated using the 3+3 design. The starting dose of 1 x
      106 transduced cells/kg (dose level 1) will enroll at least 3 subjects in the initial cohort.
      If there are no dose limiting toxicities (DLTs) within 4 weeks of the cell infusion in these
      3 subjects, then the next cohort will evaluate 2 x 106 transduced cells/kg. If there is
      toxicity in 1/3 subjects in the initial cohort, the cohort will be expanded to enroll up to 6
      subjects. During iC9-CAR19 T cell dose exploration, AP1903 (0.4 mg/kg), a dimerizing agent
      that is designed to engage and activate the caspase 9 safety switch to trigger iC9-CAR19 T
      cell death by apoptosis will be given to subjects who develop grade 4 cytokine release
      syndrome (CRS) or grade ≥3 CRS that is unresponsive to standard of care interventions, and to
      subjects who develop grade ≥3 CAR-T-cell-related encephalopathy syndrome (CRES) or grade 2
      CRES that does not improve to grade ≤1 within 72 hours with standard of care interventions.

      Cell Procurement

      Peripheral blood, up to 300 mL (in up to 3 collections) will be obtained from subjects for
      cell procurement. In subjects with low T-cell count (CD3 count as assayed by flow cytometry
      less than 200/μL) in the peripheral blood, a leukopheresis may be performed to isolate
      sufficient T cells. The parameters for pheresis will be up to 2 blood volumes

      Lymphodepleting Regimen

      Subjects will receive a "pre-conditioning" cytoreductive regimen of bendamustine 70 mg/m2/day
      administered IV followed by an IV dose of fludarabine 30 mg/m2/day administered over 3
      consecutive days. These agents will be administered per institutional guidelines. Prophylaxis
      (e.g., hydration, antiemetics, etc.) needed prior to fludarabine and bendamustine
      chemotherapy will be provided per institutional guideline

      Administration of iC9-CAR19 T cells

      Post lymphodepletion, subjects who meet eligibility criteria for cellular therapy will
      receive iC9-CAR19 T cells within 2 - 14 days after completing the lymphodepleting
      chemotherapy regimen. We will administer iC9-CAR19 post lymphodepletion at dose levels
      specified in the table in section 4.1. A recently published trial in refractory DLBCL
      established that a dose of 2 x 106 CAR19+ T cells/kg was safe and associated with significant
      in vivo expansion and we anticipate similar results with iC9-CAR19+ T cells.

      Duration of Therapy

      Therapy in this study involves 1 infusion of iC9-CAR19 cells.

      Duration of Follow-up

      Subjects who receive a cell infusion will be followed for up to 15 years for
      replication-competent retrovirus evaluation or until death, whichever occurs first. Subjects
      who are removed from study and do not receive the cellular therapy product due to
      unacceptable adverse events will be followed until resolution or stabilization of the adverse
      event.
    

Trial Arms

NameTypeDescriptionInterventions
Single Arm iC9.CAR19 T cellsExperimentalThe safety of iC9-CAR19 cells will be investigated using the 3+3 design. Dose level (DL) Dose (#transduced cells/kg) -1 1 x 10^5 1 x 10^6 2 x 10^6 DL1 will enroll 3 subjects. If no toxicity within 4 weeks, then DL 2 will enroll 3 subjects. If toxicity in 1/3 subjects in DL 1, 3 more subjects will be enrolled. If DL 1 is not tolerable, a de-escalation to DL -1 will enroll 3 subjects. If 3 subjects at the higher dose do not have DLTs more will be enrolled at that dose to get more information about toxicity. Lymphodepleting chemotherapy of IV bendamustine 70 mg/m2 and IV fludarabine 30 mg/m2/day for 3 consecutive days will be given within 2-14 days prior to cell infusion. AP1903 (0.4 mg/kg), a dimerizing agent to engage and activate the caspase 9 safety switch to trigger iC9-CAR19 T cell death by apoptosis will be given to subjects who develop severe cytokine release syndrome (CRS) or CAR-T-cell-related encephalopathy syndrome (CRES) according to the protocol.
  • Bendamustine
  • Fludarabine
  • AP1903

Eligibility Criteria

        Inclusion Criteria for the Study:

        Unless otherwise noted, subjects must meet all of the following criteria to participate in
        all stages of this study:

          -  Written informed consent and HIPAA authorization for release of personal health
             information.

          -  Adults ≥18 years of age.

          -  Histologically confirmed B-cell NHL, including the following types defined by WHO
             2016:

        Aggressive Lymphomas:

          -  DLBCL not otherwise specified (NOS)

          -  T cell/histiocyte rich large B cell lymphoma; primary cutaneous DLBCL, leg type;
             EBV-positive DLBCL NOS; DLBCL associated with chronic inflammation; Lymphomatoid
             granulomatosis; Large B-cell lymphoma with IRF4 rearrangement; Intravascular large
             B-cell lymphoma; ALK-positive large B-cell lymphoma

          -  Primary mediastinal (thymic) large B-cell lymphoma

          -  High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; high grade
             B-cell lymphoma, NOS

          -  B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and
             classical Hodgkin lymphoma

          -  Transformation of indolent lymphoma or CLL to DLBCL will also be included

        Indolent Lymphomas:

          -  Follicular lymphoma

          -  Splenic marginal zone lymphoma

          -  Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue

          -  Nodal marginal zone lymphoma

          -  Mantle cell lymphoma

          -  Subjects with CNS disease will not be excluded as long it has been stable for 3 months

             --For aggressive lymphomas, relapsed or refractory disease, defined as one of the
             following:

          -  Residual disease after primary therapy and not eligible for autologous stem cell
             transplant (ASCT)

          -  Relapsed or persistent disease after prior ASCT

          -  Beyond 1st complete remission with relapsed or persistent disease and not eligible or
             appropriate for conventional allogeneic or ASCT

               -  For indolent lymphomas, subjects must have received at least 2 prior lines of
                  therapy for their lymphoma

               -  Subjects relapsed after allogeneic stem cell transplant will be eligible if they
                  meet other inclusion criteria and have no active graft vs host disease (GVHD)

               -  Measurable or assessable disease by Lugano criteria

               -  Karnofsky score of > 60%

               -  Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth
                  control or be surgically sterile, or abstain from heterosexual activity for the
                  course of the study, and for 6 months after the study is concluded. WOCBP are
                  those who have not been surgically sterilized or have not been free from menses
                  for > 1 year. The two birth control methods can be composed of: two barrier
                  methods or a barrier method plus a hormonal method to prevent pregnancy. WOCBP
                  subjects will also be instructed to tell their male partners to use a condom.

        Exclusion Criteria for the Study:

        Subjects meeting any of the following exclusion criteria will not be able to participate in
        this study (procurement, lymphodepletion and cell infusion):

          -  Subject is pregnant or lactating.

          -  Tumor in a location where enlargement could cause airway obstruction.

          -  Current use of systemic corticosteroids at doses ≥10mg prednisone daily or its
             equivalent; those receiving <10mg daily may be enrolled at discretion of investigator.

          -  Active infection with HIV, HTLV, HBV, HCV (can be pending at the time of cell
             procurement; only those samples confirming lack of active infection will be used to
             generate transduced cells) defined as not being well controlled on therapy. Subjects
             are required to have negative HIV antibody or negative HIV viral load, negative HTLV1
             and HTLV2 antibodies, negative Hepatitis B surface antigen, and negative HCV antibody
             or viral load. In addition, subjects with positive Hepatitis B core antibody, will
             have Hepatitis B viral load tested and subjects with positive Hepatitis B viral load
             will also be excluded.

          -  Subject must either have core antibody negative HBV (results can be pending at the
             time of cell procurement) OR if a subject is hepatitis B core antibody positive they
             must have their hepatitis B viral load checked. These subjects will be excluded if
             their viral load is positive at baseline. Subjects who are core antibody positive and
             viral load negative at baseline will be considered eligible.

          -  Known additional malignancy that is active and/or progressive requiring treatment;
             exceptions include basal cell or squamous cell skin cancer, in situ cervical or
             bladder cancer, or other cancer for which the subject has been disease-free for at
             least five years.

        Eligibility criteria to be met prior to procurement:

          -  Subjects must sign a consent to undergo cell procurement.

          -  Life expectancy ≥ 12 weeks.

          -  Evidence of adequate organ function as defined by:

        The following is required within 7 days prior to procurement:

          -  Bilirubin ≤1.5 times the upper limit of normal (ULN). Subjects with Gilbert's syndrome
             may be enrolled despite a total bilirubin level >1.5 mg/dL if their conjugated
             bilirubin is <1.5× ULN)

          -  AST ≤ 3 times ULN

          -  Creatinine Clearance (CrCl) >30mL/min per Cockcroft and Gault (See Section 12.3)

          -  Pulse oximetry of >90% on room air

               -  Left ventricular ejection fraction (LVEF) ≥35% as measured by ECHO, with no
                  additional evidence of decompensated heart failure.

               -  Imaging results from within 90 days prior to procurement to assess presence of
                  active disease.

               -  Negative serum pregnancy test within 72 hours prior to procurement or
                  documentation that the subject is post-menopausal. Post-menopausal status must be
                  confirmed with documentation of absence of menses for >1 year, or documentation
                  of surgical menopause involving bilateral oophorectomy.

        Eligibility criteria to be met prior to lymphodepletion:

          -  Written informed consent to enroll in the CAR T-cell therapy trial must be obtained
             prior to lymphodepletion.

          -  Imaging results from within 7 days prior to lymphodepletion. Imaging must occur at
             least 3 weeks after most recent therapy (used as baseline measure for documentation of
             progression before the lymphodepletion) to document measurable or assessable disease.
             Imaging does not need to be repeated if it is within 7 days prior to lymphodepletion.

          -  Evidence of adequate organ function as defined by:

        The following are required within 72 hours prior to lymphodepletion:

          -  Adequate bone marrow function (ANC ≥1.0 x 109/L and platelets ≥75 x 109/L). Subjects
             cannot have received platelet transfusion within 7 days of lymphodepletion.

          -  Bilirubin ≤1.5 times the upper limit of normal (ULN). Subjects with Gilbert's syndrome
             may be enrolled despite a total bilirubin level >1.5 mg/dL if their conjugated
             bilirubin is <1.5× ULN)

          -  AST ≤ 3 times ULN

          -  Creatinine Clearance (CrCl) >30mL/min per Cockcroft and Gault

          -  Pulse oximetry of > 90% on room air

               -  Negative serum pregnancy test within 72 hours prior to lymphodepletion or
                  documentation that the subject is post-menopausal. Post-menopausal status must be
                  confirmed with documentation of absence of menses for > 1 year, or documentation
                  of surgical menopause involving bilateral oophorectomy.

               -  Subjects that have received therapy with murine antibodies must have
                  documentation of absence of human anti-mouse antibodies (HAMA) prior to
                  lymphodepletion.

               -  Available autologous transduced activated T cells product meets the certificate
                  of analysis.

               -  Has not received any investigational agents or received any tumor vaccines within
                  the previous six weeks prior to lymphodepletion.

               -  Subject is not taking a prohibited or contraindicated medication prior to
                  lymphodepletion. Contraindicated medications should be discontinued at least two
                  weeks prior to the scheduled lymphodepletion or by at least 5 half-lives of the
                  contraindicated medication, whichever is shorter.

               -  Subject is not taking strong inhibitors of CYP1A2 (e.g., fluvoxamine,
                  ciprofloxacin) as these may increase plasma concentrations of bendamustine, and
                  decrease plasma concentrations of its metabolites. See
                  http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong
                  inhibitors of CYP1A2. (This applies to subjects who receive bendamustine for
                  lymphodepletion (required) up through 72 hours after the last dose of
                  bendamustine).

               -  Subject has not received chemotherapy within the previous 3 weeks prior to
                  lymphodepletion.

        Eligibility criteria to be met prior to cell infusion after lymphodepletion:

          -  No evidence of uncontrolled infection or sepsis.

          -  Negative serum pregnancy within 7 days of cell infusion (does not need to be repeated
             if pre-lymphodepletion pregnancy test is within window).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with adverse events as a measure of safety and tolerability of iC9-CAR19 T cells
Time Frame:4 weeks
Safety Issue:
Description:Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. CAR-T-cell-related encephalopathy (CRES) symptoms will be graded according to the criteria outline in Section 12.6 CRES Grading in the protocol and CRS symptoms will be graded according to criteria outlined in Section 12.2 CRS Grading of the protocol.

Secondary Outcome Measures

Measure:Identify a recommended phase 2 dose (RP2D) of iC9-CAR19 T cells in subjects with relapsed or refractory B-cell lymphoma
Time Frame:4 weeks
Safety Issue:
Description:The recommended phase 2 dose of iC9-CAR19 cells will be determined based on 3+3 dose finding rules and the tolerability of iC9-CAR19 cells assessed by NCI-CTCAE criteria, Cytokine release syndrome (CRS) grading criteria, and CAR‑T‑cell-related encephalopathy syndrome (CRES) per CAR-T-cell therapy-associated toxicity (CARTOX-10). In the CARTOX-10, one point is assigned for each of the following tasks that is performed correctly (normal cognitive function is defined by an overall score of 10): orientation to year, month, city, hospital, and President/Prime Minister of country of residence (total of 5 points); name three objects — for example, point to clock, pen, button (maximum of 3 points); write a standard sentence, for example, 'our national bird is the bald eagle' (1 point); count backwards from 100 in tens (1 point).
Measure:Survival of iC9-CAR19 T cells in vivo
Time Frame:15 years
Safety Issue:
Description:Persistence of iC9-CAR19 T cells in vivo will be determined by quantitative polymerase chain reaction (PCR) and flow cytometry in samples of peripheral blood.
Measure:Overall response rate (ORR) mediated by autologous iC9-CAR19 T cells administered to subjects with relapsed or refractory B-cell lymphoma.
Time Frame:15 years
Safety Issue:
Description:ORR (Complete Response (CR)) to iC9-CAR19 T cell therapy will be determined using the revised Lugano criteria. CR= no new lesions; normal bone marrow; Target nodes/nodal masses must regress to ≤ 1.5 cm in LDi; no extralymphatic sites of disease; and/or a PET-CT score of 1, 2, or 3* with or without a residual mass.
Measure:Overall survival (OS) in subjects with relapsed or refractory B-cell lymphoma following infusion of iC9-CAR19 T cells.
Time Frame:15 years
Safety Issue:
Description:OS will be measured from the date of administration of iC9-CAR19 T cells to the date of death. Subjects who have not died by the analysis data cut-off date will be censored at their last date of contact.
Measure:Progression free survival (PFS) in subjects with relapsed or refractory B-cell lymphoma following infusion of iC9-CAR19 T cells
Time Frame:15 years
Safety Issue:
Description:PFS is defined from day of iC9-CAR19 T cell infusion to the date of disease progression per the Lugano criteria or death as a result of any cause. Subjects who do not meet criteria for progression by the analysis data cut-off date will be censored at their last evaluable disease assessment date. Progression is defined as PET-CT score 4 or 5 with an increase in intensity of uptake from baseline and/or New FDG-avid foci consistent with lymphoma at interim or end-of-treatment assessment; An individual node/lesion must be abnormal with: Longest diameter (LDi) > 1.5 centimeter (cm) and Increase by ≥ 50% from nadir and an increase in LDi or Shortest Diameter from nadir 0.5 cm for lesions ≤ 2 cm 1.0 cm for lesions > 2 cm
Measure:Duration of response (DOR) in subjects with relapsed or refractory B-cell lymphoma who experience an objective response following infusion of iC9-CAR19 T cells.
Time Frame:15 years
Safety Issue:
Description:DOR is defined for subjects who experience an objective response as the date of first objective response to disease progression per the Lugano criteria, or death as a result of any cause. Subjects who do not meet criteria for progression or death by the analysis cut-off date will be censored at their last evaluable disease assessment date.
Measure:Change in patient-reported symptoms
Time Frame:1 year
Safety Issue:
Description:Patient reported symptoms will be measured using selected symptoms from the NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a patient-reported outcome measurement system developed to characterize the frequency, severity and interference of symptomatic treatment toxicities. Each of the symptom terms included in the PRO-CTCAE is assessed relative to one or more distinct attributes, including presence/absence, frequency, severity, and/or interference with usual or daily activities. Responses are provided on a 5-point Likert scale: Frequency item: How OFTEN did you have? (Never / Rarely / Occasionally / Frequently / Almost constantly); Severity item: What was the SEVERITY of your at its WORST? (None / Mild / Moderate / Severe / Very severe);Interference item: How much did INTERFERE with your usual or daily activities? (Not at all / A little bit / Somewhat / Quite a bit / Very much)
Measure:Change in physical function
Time Frame:1 year
Safety Issue:
Description:The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a v1.0. assesses one's ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. "Physical Function" is inclusive of the term "disability" and includes the full spectrum of physical functioning from severe impairment to exceptional physical abilities. Each question has five response options ranging in value from one to five, resulting in a total score (T-score) from 0 to 100. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
Measure:Change in health related quality of life
Time Frame:1 year
Safety Issue:
Description:The Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health measures assess an individual's physical, mental, and social health. The measures are generic, rather than disease-specific, and often use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. Each question has five response options ranging in value from one to five, which are summed into T-score values for physical and mental health. A higher PROMIS T-score represents more of the concept being measured. Thus, a person who has T- scores of 60 for the Global Physical Health or Global Mental Health scales is one standard deviation better (more healthy) than the general population.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:UNC Lineberger Comprehensive Cancer Center

Trial Keywords

  • CAR T cells
  • CD19
  • Lymphoma
  • AP1903
  • Cytokine Release Syndrome
  • Neurotoxicity

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