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

November 10, 2023 updated by: Precigen, Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

71

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Recruiting
        • National Institutes of Health (NIH)
        • Contact:
        • Principal Investigator:
          • Nicholas Tschernia
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutch/University of Washington Cancer Consortium
        • Principal Investigator:
          • John Liao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

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 signing consent.
  • Patients with known or treated brain metastases.
  • Patients with an active seizure disorder.

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (PRGN-3005 UltraCAR-T cells) IP Administration
Patients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy.
Biological: PRGN-3005 UltraCAR-T cells
Given IP
Biological: PRGN-3005 UltraCAR-T cells
Given IV
Experimental: Treatment (PRGN-3005 UltraCAR-T cells) IV Administration
Patients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy.
Biological: PRGN-3005 UltraCAR-T cells
Given IP
Biological: PRGN-3005 UltraCAR-T cells
Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 12 months after infusion
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
Up to 12 months after infusion
Maximal tolerated dose of PRGN-3005
Time Frame: Up to 28 days
Will be determined by a 3 X 3 dose escalation study for both intraperitoneal infusion and intravenous infusion of the trial.
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of anti-tumor activity
Time Frame: Up to 5 years
Graded according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Up to 5 years
Number of PRGN-3005 T Cells
Time Frame: Up to 12 months post treatment
Number of PRGN-3005 T Cells present in patients treated with PRGN-3005
Up to 12 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precigen, Inc

Investigators

  • Study Director: Amy R. Lankford, PhD, Precigen, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

November 15, 2028

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1004303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Fallopian Tube Carcinoma

Clinical Trials on PRGN-3005 UltraCAR-T cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe