Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Patients With Advanced Solid Tumors (TROPIKANA)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06066424
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Rimiducid — DRUG
    Given by (IV) vein
  • TROP2-CAR-NK Cells — DRUG
    Given by (IV) vein
  • Fludarabine phosphate — DRUG
    Given by (IV) vein
  • Cyclophosphamide — DRUG
    Given by (IV) vein

Study Details

To find the recommended dose of TROP2- CAR-NK cells that can be given to participants with advanced forms of solid tumors.

Key Dates

Start date
Oct 24, 2023
Status verified
May 2026
Primary completion
Apr 30, 2038
Completion
Apr 30, 2040

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Participants who are enrolled in Dose Escalation, Participants will be assigned to a dose level of TROP2- CAR-NK cells based on when you join this study. Up to 5 dose levels of TROP2-CARNK cells will be tested. At least 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of TROP2-CAR-NK cells is found. Participants who are enrolled in the Dose Expansion, Participants will receive TROP2-CAR-NK cells at the recommended dose that was found in the Dose Escalation.
  • Experimental: Dose Expansion Cohort 1
    Participants who are enrolled in Dose Escalation, Participants will be assigned to a dose level of TROP2- CAR-NK cells based on when you join this study. Up to 5 dose levels of TROP2-CARNK cells will be tested. At least 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of TROP2-CAR-NK cells is found. Participants who are enrolled in the Dose Expansion, Participants will receive TROP2-CAR-NK cells at the recommended dose that was found in the Dose Escalation.
  • Experimental: Dose Expansion Cohort 2
    Participants who are enrolled in Dose Escalation, Participants will be assigned to a dose level of TROP2- CAR-NK cells based on when you join this study. Up to 5 dose levels of TROP2-CARNK cells will be tested. At least 3 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of TROP2-CAR-NK cells is found. Participants who are enrolled in the Dose Expansion, Participants will receive TROP2-CAR-NK cells at the recommended dose that was found in the Dose Escalation.

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
Ecaterina Dumbrava, M D
[email protected]
713-792-3934
Ecaterina Dumbrava, M D (PRINCIPAL_INVESTIGATOR)

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