Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by David Oh, MD (ucsf)
Headshot of David Oh
David Oh

Description

Summary

The goal of this clinical trial is to learn if OPB-201 is safe in recurrent endometrial and platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-201. Participants will have their own T cells modified in a laboratory and given back to them as OPB-201 in this one-time treatment. Participants will be in the hospital when they receive OPB-201 and then be checked at the clinical site frequently for the first few months.

Official Title

A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB 201, an Autologous PReferentially Expressed Antigen of MElanoma (PRAME) T Cell Receptor (TCR) T Cell Therapy in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.

Details

A phase 1a/b study to evaluate the safety and efficacy of OPB-201, an autologous PReferentially expressed Antigen of MElanoma (PRAME) T cell receptor (TCR) T cell therapy in recurrent endometrial and platinum-resistant ovarian cancer.

Keywords

Endometrial Cancer Recurrent, Endometrial Cancer, Advanced Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Recurrent, Platinum Resistant Ovarian Cancer, Endometrial Cancers, Outpace, advanced ovarian cancer, cell therapy, TCR-T, TCR, PRAME directed TCR, Endometrial Neoplasms, Ovarian Neoplasms, OPB-201

Eligibility

You can join if…

Open to females ages 18 years and up

  1. Age ≥ 18 years of age at the time of signing the informed consent form.
  2. Histologically confirmed diagnosis of endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
  3. Received at least 1 prior line of systemic chemotherapy including a platinum-based chemotherapy.
  4. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
  5. Measurable disease.
  6. Consent to provide archived tumor tissue sample.
  7. ECOG performance status of 0 or 1.
  8. Adequate organ function.
  9. HLA-A *02:01 or HLA-A *02:02
  10. PRAME positive tumor

You CAN'T join if...

  1. Women of child-bearing potential who are pregnant or breastfeeding.
  2. Uncontrolled bacterial, fungal, or viral infections.
  3. Active infection requiring systemic therapy.
  4. Bleeding or thrombotic disorders or at risk for severe hemorrhage.
  5. Any form of primary immunodeficiency.
  6. Had an allogenic tissue/solid organ transplant.
  7. Active autoimmune disease.
  8. Concurrent treatment with systemic high dose corticosteroids.
  9. Unresolved acute effects of any prior therapy.
  10. Other exclusions as stated in the protocol.

Locations

  • UCSF - Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94143 United States
  • MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Lead Scientist at University of California Health

  • David Oh, MD (ucsf)
    I am a physician-scientist focused on developing novel immunotherapies with enhanced activity and reduced toxicity, for patients with solid cancers. Clinically, I see patients in the Cancer Immunotherapy Program where I lead numerous early phase trials, with a particular focus on adoptive cell therapies for solid tumors (CAR-T and TCR).

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Outpace Bio, Inc.
ID
NCT07664735
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated