Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Platinum Resistant Epithelial Ovarian Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05225363
Phase
PHASE1
Status
Recruiting
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Conditions

  • Platinum-Resistant Ovarian Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chimeric Antigen Receptor T-cells — BIOLOGICAL
    Receive TAG72-CAR T cells IP
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV

Study Details

This phase I trial tests the safety, side effects, and best dose of TAG72-chimeric antigen receptor (CAR) T cells in treating patients with epithelial ovarian cancer that remains despite treatment with platinum therapy (platinum resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize TAG72, a protein on the surface of tumor cells. These TAG72-specific T cells may help the body's immune system identify and kill TAG72+ cancer cells.

Key Dates

Start date
May 5, 2022
Status verified
Jun 2025
Primary completion
Oct 5, 2026
Completion
Jun 5, 2027

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (TAG72-CAR T cells)
    Patients receive fludarabine IV and cyclophosphamide IV on days -5 to -3. Patients receive TAG72-CAR T cells IP on day 0.

Primary Outcome Measure

Incidence of dose limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Lorna C. Rodriguez
[email protected]
626-456-4673
[email protected]
Lorna Rodriguez (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Medical Center· Duarte, CA

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