Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06358430
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Fludarabine Phosphate — DRUG
    Given by IV
  • Cyclophosphamide — DRUG
    Given by IV
  • Cetuximab — DRUG
    Given by IV
  • TROP2-CAR-NK Cells — DRUG
    Given by IV
  • Rimiducid (AP1903) — DRUG
    Given by IV
  • Lymphodepleting Chemotherapy — PROCEDURE
    Given by Chemotherapy

Study Details

To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.

Key Dates

Start date
Dec 2, 2024
Status verified
May 2026
Primary completion
Jan 18, 2029
Completion
Jan 18, 2029

Study Design

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

Arms

  • Experimental: Dose Escalation + Dose Expansion
    Up to 5 dose levels of TROP2-CAR-NK cells will be tested in the Dose Escalation phase. Up to 12 participants maximum will be enrolled at any dose level, in groups of 3 participants at a time. 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 recommended dose of TROP2-CAR-NK cells is found. When that dose level is confirmed, the final group of 12 participants will be enrolled at that dose level.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Maria Pia Morelli, MD, PhD
[email protected]
713-792-2828
Maria Pia Morelli, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
MD Anderson Cancer Center· Houston, TX

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