Phase 1 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)
M.D. Anderson Cancer Center
Summary
To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.
Description
Primary Objective: 1. To determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of TROP2-CAR-NK cells combined with cetuximab in patients with MRD CRC. 2. To evaluate circulating tumor DNA (ctDNA) clearance (undetectable) at 3 months Secondary Objectives: 1. Determine progression-free survival. 2. To quantify the persistence of infused allogeneic donor TROP2-CAR-NK cells in the peripheral blood of the recipient. 3. To evaluate blood- and tissue-based biomarkers at baseline associated with response and resistance to TROP2-CAR-NK cell infusion in…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must be 18 years or older. 2. Participants must be willing and able to provide informed consent. 3. Willing and able to comply with clinical trial instructions and requirements. Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation. 4. In both the dose escalation and dose expansion cohorts, participants must have documented colorectal cancer (CRC) with MRD following complete disease resection followed by standard-of…
Interventions
- DrugFludarabine Phosphate
Given by IV
- DrugCyclophosphamide
Given by IV
- DrugCetuximab
Given by IV
- DrugTROP2-CAR-NK Cells
Given by IV
- DrugRimiducid (AP1903)
Given by IV
- ProcedureLymphodepleting Chemotherapy
Given by Chemotherapy
Location
- MD Anderson Cancer CenterHouston, Texas