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)

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

Primary Objective:

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.
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).

Eligibility

Relevant conditions:

Colorectal Cancer

Minimal Residual Disease

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.

locations

Contact Information

Overall Contact

Maria Pia Morelli, MD, PhD

mpmorelli@mdanderson.org

(713) 745-1297

Data sourced from ClinicalTrials.gov