M.D. Anderson Cancer Center
To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.
Colorectal Cancer
Minimal Residual Disease
Fludarabine Phosphate
Cyclophosphamide
Cetuximab
TROP2-CAR-NK Cells
Rimiducid (AP1903)
Lymphodepleting Chemotherapy
Phase 1
Primary Objective: To determine the safety, tolerability, optimal cell dose (OCD), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC. To evaluate circulating tumor DNA (ctDNA) clearance (undetectable) at 3 months Secondary Objectives: Determine progression-free survival. To quantify the persistence of infused allogeneic donor TROP2-CAR-NK cells in the peripheral blood of the recipient. To evaluate blood- and tissue-based biomarkers at baseline associated with response and resistance to TROP2-CAR-NK cell infusion in combination with cetuximab. Exploratory Objectives: To profile and assess dynamic immune changes in the tumor microenvironment. Quantify the average circulating ctDNA change from TROP2-CAR-NK infusion to progression or initiation of a new cancer therapy and association with PFS. To evaluate patient-reported quality of life (QoL).
Study Type : | Interventional |
Estimated Enrollment : | 42 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | 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) |
Actual Study Start Date : | October 31, 2024 |
Estimated Primary Completion Date : | January 18, 2027 |
Estimated Study Completion Date : | January 18, 2029 |
Arm | Intervention/treatment |
---|---|
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. |
Drug: Fludarabine Phosphate Drug: Cyclophosphamide Drug: Cetuximab Drug: TROP2-CAR-NK Cells Drug: Rimiducid (AP1903) Procedure: Lymphodepleting Chemotherapy |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
MD Anderson Cancer Center
Houston, Texas, United States, 77030