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NCT03907527Active, not recruitingPhase 1

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

Phase I/Ib Study Evaluating Safety and Efficacy of PRGN-3005 UltraCAR-T® (Autologous CAR T Cells) in Advanced Stage Platinum Resistant Ovarian Cancer Patients

Source: ClinicalTrials.gov · Last updated 8 Nov 2024

Brief summary (registry, in English)

This is a Phase I/Ib dose escalation, dose expansion, study to evaluate the safety and identify the recommended dose 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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
71 (estimated)
First submitted
5 Apr 2019
Start date
30 Apr 2019
Primary completion date
15 Dec 2024
Lead sponsor
Precigen, Inc
NCT number
NCT03907527

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 71
  • From 30 Apr 2019 to the primary completion date, 15 Dec 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 within 28 days of receiving another investigational agent.
  • Any female patient \<60 years old 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.

Other illness

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

Lab values

  • Patients with CA 125 =\< ULN during screening.

Other

  • Patients with severe, symptomatic ascites requiring diuretics, regular paracentesis, or other invasive interventions.
  • Women who are pregnant or breast feeding.
  • Patients who are simultaneously enrolled in any other treatment study.
  • Clinical or radiological evidence of acute bowel obstruction within 30 days of signing consent.
  • Patients with known or treated brain metastases.

Who the study is looking for

  • Women 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 by RECIST 1.1 criteria 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 14 days from previous cytotoxic chemotherapy at time of cell collection.
  • Laboratory values must indicate adequate organ function.
  • Patients must be at least 28 days post systemic steroids prior to enrollment except as premedication for contrast allergy and/or other protocol-mandated medication.
  • Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 2.
  • Patients must have recovered from major acute infections and/or recent surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment.
  • Negative 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Institutes of Health (NIH)
Coordinator of this site? Confirm its status
BethesdaUnited StatesUnknown status
Fred Hutch/University of Washington Cancer Consortium
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.