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

Precigen, Inc2 sites in 1 country71 target enrollmentApril 30, 2019

InterventionsPRGN-3005 UltraCAR-T cells

DrugsPRGN-3005 UltraCAR-T cells

Overview

Phase: Phase 1
Intervention: PRGN-3005 UltraCAR-T cells
Conditions: Platinum-Resistant Fallopian Tube Carcinoma
Sponsor: Precigen, Inc
Enrollment: 71
Locations: 2
Primary Endpoint: Incidence of adverse events
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 30, 2019

End Date

November 15, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

Female

Investigators

Sponsor

Precigen, Inc

Responsible Party

Sponsor

Eligibility Criteria

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 =\<
•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.

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.

Arms & Interventions

Treatment (PRGN-3005 UltraCAR-T cells) IP Administration

Patients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy.

Intervention: PRGN-3005 UltraCAR-T cells

Treatment (PRGN-3005 UltraCAR-T cells) IV Administration

Patients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy.

Intervention: PRGN-3005 UltraCAR-T cells

Outcomes

Primary Outcomes

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

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.