Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer, Mesonephric-like Adenocarcinoma, and Pancreatic Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05922930
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • TROP2-CAR-NK — DRUG
    Given by IP (intraperitoneal)
  • Cyclophosphamide — DRUG
    Given by IV (vein)
  • Fludarabine — DRUG
    Given by IV (vein)

Study Details

To find the recommended dose of TROP2- CAR-NK given intraperitoneally (directly into the abdominal cavity) to patients with highgrade serous ovarian cancer that has not responded to previous treatment or is resistant to treatment.

Key Dates

Start date
Oct 11, 2023
Status verified
May 2026
Primary completion
Oct 15, 2027
Completion
Jan 15, 2028

Study Design

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

Arms

  • Experimental: TROP2-CAR-NK
    Participants will receive 1 dose of TROP2-CAR-NK and will visit the study clinic up to 16 times to have tests and procedures (such as blood draws, biopsies, and CT scans). Participants will receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) for 3 days in a row. Participants will receive cyclophosphamide and fludarabine by vein over about 3 hours total.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Amir Jazeri, MD
[email protected]
713-745-1613
Amir Jazeri, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Ovarian cancerPancreatic cancer
By specialty
OncologyGynecologic oncologyWomen's healthGI oncology
By research site
M D Anderson Cancer Center· Houston, TX

Related Studies