Clinical Trials /

Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia Using CD7-Specific CAR-T Cells

NCT04572308

Description:

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of recurrent or refractory T-cell acute lymphoblastic leukemia

Related Conditions:
  • T-Cell Acute Lymphoblastic Leukemia
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia Using CD7-Specific CAR-T Cells
  • Official Title: Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia Using CD7-Specific CAR-T Cells

Clinical Trial IDs

  • ORG STUDY ID: CD7 CAR-T for T-ALL
  • NCT ID: NCT04572308

Conditions

  • T-All

Interventions

DrugSynonymsArms
CD7 CAR-TCD7 CAR-T

Purpose

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of recurrent or refractory T-cell acute lymphoblastic leukemia

Detailed Description

      The CARs consist of an anti-CD7 single-chain variable fragment(scFv), a portion of the human
      CD137(4-1BB) molecule, and the intracellular component of the human CD3ζ molecule. Prior to
      CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T
      cell infusion, the patients will be evaluated for adverse reactions and efficacy.

      The Main research objectives:

      To evaluate the safety and efficacy of CD7 CAR-T cells in patients with recurrent or
      refractory T-ALL

      The Secondary research objectives:

      To investigate the cytokinetic characteristics of CD7 CAR-T cells in patients with recurrent
      or refractory T-ALL
    

Trial Arms

NameTypeDescriptionInterventions
CD7 CAR-TExperimentalPatients will be treated with CD7 CAR-T cells
  • CD7 CAR-T

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of refractory or relapsed T-cell acute lymphoblastic leukemia (T-ALL)
             according to the NCCN 2019.V2, the definition of refractory is failing to achieve
             complete remission after induction therapy ; the definition of relapse is either
             peripheral blood or bone marrow

          2. CD7-positive tumor (≥70% CD7 positive blasts by flow cytometry or immunohistochemistry
             (tissue) assessed by a CLIA certified Flow Cytometry/Pathology laboratory). tumors
             burden >5%,or MRD+, or new extramedullary lesions reappeared.

          3. Life expectancy greater than 12 weeks

          4. KPS or Lansky score≥60

          5. HGB≥70g/L (can be transfused)

          6. oxygen saturation of blood>90%;

          7. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and
             alanine aminotransferase (ALT) ≤ 5×upper limit of normal

          8. Informed consent explained to, understood by and signed by patient/guardian.

        Exclusion Criteria:

          1. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial
             infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT,
             per investigator discretion. Cardiac echocardiography with LVSF (left ventricular
             shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or
             clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart
             Association) III or IV (Confirmation of absence of these conditions on echocardiogram
             within 12 months of treatment)

          2. Has an active GvHD;

          3. Has a history of severe pulmonary function damaging;

          4. With other tumors which is/are in advanced malignant and has/have systemic metastasis;

          5. Severe or persistent infection that cannot be effectively controlled;

          6. Merging severe autoimmune diseases or immunodeficiency disease;

          7. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);

          8. Patients with HIV infection or syphilis infection;

          9. Has a history of serious allergies on Biological products (including antibiotics);

         10. Clinically significant viral infection or uncontrolled viral reactivation of
             EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human
             herpesvirus)-6.

         11. Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular
             ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS
             involvement;

         12. Being pregnant and lactating or having pregnancy within 12 months;

         13. Any situations that the researchers believe will increase the risks for the subject or
             affect the results of the study.
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:2 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety: Incidence and severity of adverse events
Time Frame:First 1 month post CAR-T cells infusion
Safety Issue:
Description:To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

Secondary Outcome Measures

Measure:duration of response (DOR)
Time Frame:24 months post CAR-T cells infusion
Safety Issue:
Description:duration of response (DOR)
Measure:Efficacy: progression-free survival (PFS)
Time Frame:24 months post CAR-T cells infusion
Safety Issue:
Description:progression-free survival (PFS) time
Measure:CAR-T proliferation
Time Frame:3 months post CAR-T cells infusion
Safety Issue:
Description:the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method
Measure:CAR-T proliferation
Time Frame:3 months post CAR-T cells infusion
Safety Issue:
Description:percentage of CD7 CAR- T cells measured by flow cytometry method
Measure:Cytokine release
Time Frame:First 1 month post CAR-T cells infusion
Safety Issue:
Description:Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hebei Senlang Biotechnology Inc., Ltd.

Trial Keywords

  • T-ALLCD7,CAR-T

Last Updated

September 30, 2020