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CAR T-cell Therapy

Modified CAR T Cells for Ovarian Cancer

Phase 1
Waitlist Available
Research Sponsored by Precigen, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2
Patients must be capable of understanding and providing a written informed consent
Must not have
Patients with known or treated brain metastases
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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses modified immune cells to target and kill ovarian cancer cells.

Who is the study for?
This trial is for women with advanced, recurrent ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum chemotherapy. Participants must have measurable disease and be in good health otherwise. They should not be pregnant and agree to use two contraception methods during the study.
What is being tested?
The trial tests PRGN-3005 UltraCAR-T cells, which are modified immune cells designed to target and kill tumor cells in patients with certain types of cancer that have spread or returned after treatment.
What are the potential side effects?
Potential side effects may include reactions related to the immune system targeting healthy cells by mistake, flu-like symptoms, fatigue, fever, as well as risks associated with cell infusions such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I can understand and sign a consent form.
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My ovarian, fallopian tube, or peritoneal cancer is resistant to standard treatments.
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My cancer worsened within 6 months after platinum-based treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or have had treatment for brain metastases.
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I have lung issues like high blood pressure in lungs, scarring, or difficulty breathing and my oxygen levels or lung tests are very low.
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I am not pregnant or breastfeeding.
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I do not have serious heart conditions like unstable angina, severe heart failure, or significant hypotension.
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I have an autoimmune disease that is not controlled even with treatment.
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I need regular treatments for severe fluid buildup in my abdomen.
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I have a history of HIV, West Nile, Zika, or active hepatitis B or C.
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I have an active seizure disorder.
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I am a woman under 60 and cannot become pregnant due to menopause or sterilization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Maximal tolerated dose of PRGN-3005
Secondary study objectives
Evidence of anti-tumor activity
Number of PRGN-3005 T Cells

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment (PRGN-3005 UltraCAR-T cells) IV AdministrationExperimental Treatment1 Intervention
Patients receive autologous PRGN-3005 UltraCAR-T cells via IV administration with or without lymphodepleting chemotherapy.
Group II: Treatment (PRGN-3005 UltraCAR-T cells) IP AdministrationExperimental Treatment1 Intervention
Patients receive autologous PRGN-3005 UltraCAR-T cells via IP administration with or without lymphodepleting chemotherapy.

Find a Location

Who is running the clinical trial?

Precigen, IncLead Sponsor
6 Previous Clinical Trials
314 Total Patients Enrolled
PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.Lead Sponsor
2 Previous Clinical Trials
126 Total Patients Enrolled
Amy R. Lankford, PhDStudy DirectorPrecigen, Inc
1 Previous Clinical Trials
88 Total Patients Enrolled

Media Library

PRGN-3005 UltraCAR-T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03907527 — Phase 1
~1 spots leftby Dec 2024
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