← Back to Search

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
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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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 below
Select...
My ovarian, fallopian tube, or peritoneal cancer is resistant to standard treatments.
Select...
My cancer can be measured and is visible on scans.
Select...
I have a BRCA mutation and have finished all standard treatments, including PARP inhibitors.
Select...
My blood tests show my organs are working well.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am willing to use two forms of birth control before, during, and for 4 months after my treatment.
Select...
I have recovered from any recent surgeries or major infections and don't have other serious illnesses.
Select...
My cancer worsened within 6 months after platinum-based treatment.
Select...
I haven't taken systemic steroids for at least 28 days, except as premedication.
Select...
I can understand and sign a consent form.
Select...
It has been at least 14 days since my last chemotherapy.

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

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

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
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

Media Library

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open call for participants in this trial?

"Evidenced by the clinicaltrials.gov page, this trial is currently open to participants. The medical experiment was initiated on April 30th 2019 and its details were most recently updated as of June 28th 2022."

Answered by AI

What potential adverse effects could arise from the use of PRGN-3005 UltraCAR-T cells?

"The safety of PRGN-3005 UltraCAR-T cells is deemed to be a 1 on the scale, as this phase one trial only has limited data that supports its efficacy and security."

Answered by AI

What is the total sample size for this medical trial?

"Affirmative. According to clinicaltrials.gov, the research study went live on April 30th 2019 and was last revised on June 28th 2022. 71 individuals are being recruited from one medical centre for this trial."

Answered by AI
~10 spots leftby Dec 2024