Clinical Trials /

Modified Immune Cells (Autologous CAR T Cells) in Treating Patients With Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT03907527

Description:

This is a phase I dose escalation study to identify the best dose and side effects of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back, and is resistant to platinum chemotherapy. Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Modified Immune Cells (Autologous CAR T Cells) in Treating Patients With Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
  • Official Title: Phase I Study Evaluating Benefit of PRGN-3005 UltraCAR-T™ (Autologous CAR T Cells) in Advanced Stage Platinum Resistant Ovarian Cancer Patients

Clinical Trial IDs

  • ORG STUDY ID: RG1004303
  • SECONDARY ID: NCI-2019-01789
  • NCT ID: NCT03907527

Conditions

  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma
  • Progressive Disease
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Refractory Fallopian Tube Carcinoma
  • Refractory Ovarian Carcinoma
  • Refractory Primary Peritoneal Carcinoma
  • Stage III Fallopian Tube Cancer AJCC v8
  • Stage III Ovarian Cancer AJCC v8
  • Stage III Primary Peritoneal Cancer AJCC v8
  • Stage IIIA Fallopian Tube Cancer AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIA Primary Peritoneal Cancer AJCC v8
  • Stage IIIA1 Fallopian Tube Cancer AJCC v8
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IIIA2 Fallopian Tube Cancer AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Stage IIIB Fallopian Tube Cancer AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8
  • Stage IIIB Primary Peritoneal Cancer AJCC v8
  • Stage IIIC Fallopian Tube Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage IIIC Primary Peritoneal Cancer AJCC v8
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Stage IVA Fallopian Tube Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVA Primary Peritoneal Cancer AJCC v8
  • Stage IVB Fallopian Tube Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8
  • Stage IVB Primary Peritoneal Cancer AJCC v8

Interventions

DrugSynonymsArms
PRGN-3005 UltraCAR-T cellsTreatment (PRGN-3005 UltraCAR-T cells)

Purpose

This is a phase I dose escalation study to identify the best dose and side effects of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back, and is resistant to platinum chemotherapy. Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.

Trial Arms

NameTypeDescriptionInterventions
Treatment (PRGN-3005 UltraCAR-T cells)ExperimentalPatients receive autologous PRGN-3005 UltraCAR-T cells IP or IV.
  • PRGN-3005 UltraCAR-T cells

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosed with recurrent, advanced, platinum resistant ovarian, fallopian tube, and
             primary peritoneal cancer that have progressed after receiving standard of care
             therapies or are not eligible to receive available therapies with known clinical
             benefit will be eligible for the study. Patients must have measurable disease that can
             be accurately measured in at least one dimension as >= 1.0 cm or > 1.5 cm lymph node
             with computed tomography (CT), ultrasound, or magnetic resonance imaging (MRI)
             techniques.

               -  Platinum resistant is defined as progression of disease within six months of
                  platinum regimen.

               -  Patients with BRCA mutations who have completed standard therapies (including
                  PARP inhibitors) are allowed on this study.

          -  Patients must be capable of understanding and providing a written informed consent.

          -  Patients must be of any race or ethnicity.

          -  Patients at least 14 days from previous cytotoxic chemotherapy.

          -  Laboratory values must indicate adequate organ function

          -  Patients must be at least 28 days post systemic steroids prior to enrollment.

          -  Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score
             of =< 2.

          -  Patients must have recovered from major infections and/or surgical procedures, and in
             the opinion of the investigator, not have any significant active concurrent medical
             illnesses precluding protocol treatment.

          -  Negative serum pregnancy test for women of childbearing potential. Women of
             childbearing potential are those who have not been surgically sterilized, are < 60
             years old, or have had menses within the past 12 months.

          -  Women of childbearing potential must be willing to use 2 methods of contraception
             before, during, and at least 4 months after the PRGN-3005 cell infusion.

        Exclusion Criteria:

          -  Patients with any of the following cardiac conditions:

               -  Symptomatic restrictive cardiomyopathy

               -  Unstable angina or symptomatic coronary artery disease within 4 months prior to
                  enrollment

               -  New York Heart Association functional class III-IV heart failure on active
                  treatment

               -  Symptomatic pericardial effusion

               -  Congestive heart failure

               -  Clinically significant hypotension.

          -  Patients with CA 125 =< ULN during screening.

          -  Patients with history of human immunodeficiency virus (HIV), West Nile, Zika, or
             active hepatitis B or C infections.

          -  Patients with severe, symptomatic ascites requiring diuretics, regular paracentesis,
             or other invasive interventions.

          -  Patients within 28 days of receiving another investigational agent.

          -  Patients with pulmonary hypertension, pulmonary fibrosis, or restrictive lung disease,
             patients with baseline oxygen saturation on room air < 92%, forced expiratory volume
             in 1 second (FEV1) =< 50%, or diffusion capacity of the lung for carbon monoxide
             (DLco) (corrected) of < 40% will be excluded.

          -  Women who are pregnant or breast feeding.

          -  Patients with second malignancy within the last 5 years excluding basal carcinoma of
             the skin, squamous carcinoma of the skin, or in situ cervical dysplasia that has
             undergone curative therapy.

          -  Patients with an active autoimmune disease requiring immunosuppressive therapy or
             uncontrolled with treatment.

          -  Patients who are simultaneously enrolled in any other treatment study.

          -  Clinical or radiological evidence of acute bowel obstruction within 30 days of
             enrollment.

          -  Patients with known or treated brain metastases.

          -  Patients with an active seizure disorder.

          -  Any female patient who does not meet at least one of the following criteria will be
             considered to have reproductive potential:

               -  Post-menopausal for at least 12 consecutive months (i.e., no menses), or

               -  Undergone a sterilization procedure (hysterectomy, salpingectomy, or bilateral
                  oophorectomy; tubal ligation is not considered a sterilization procedure).
                  Pregnancy test for females of reproductive potential must be negative within 14
                  days before leukapheresis.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of adverse events
Time Frame:Up to 12 months after infusion
Safety Issue:
Description:Toxicity grading will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5.0 and monitoring of adverse events

Secondary Outcome Measures

Measure:Evidence of anti-tumor activity
Time Frame:Up to 5 years
Safety Issue:
Description:Graded according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Fred Hutchinson Cancer Research Center

Trial Keywords

  • Platinum resistant
  • Ovarian Cancer

Last Updated

December 17, 2019