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CAR T-cell Therapy
Modified CAR T Cells for Ovarian Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can understand and sign a consent form.
Select...
My ovarian, fallopian tube, or peritoneal cancer is resistant to standard treatments.
Select...
My cancer worsened within 6 months after platinum-based treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximal tolerated dose of PRGN-3005
Secondary outcome measures
Evidence of anti-tumor activity
Number of PRGN-3005 T Cells
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.
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Who is running the clinical trial?
Precigen, IncLead Sponsor
5 Previous Clinical Trials
272 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
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Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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