Actively Recruiting
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)
Led by M.D. Anderson Cancer Center · Updated on 2026-01-15
42
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
Bellicum Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Ability and willingness to provide informed consent
- Willingness and ability to comply with all clinical trial procedures
- Documented colorectal cancer with minimal residual disease after complete resection and standard adjuvant treatment
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Female participants must not be women of childbearing potential or agree to contraception during and 6 months post treatment
- Female participants must have a negative pregnancy test within 72 hours before lymphodepleting chemotherapy
- Male participants must agree to contraception during and 6 months post treatment
- Adequate organ function as defined by blood counts, liver, kidney, and coagulation tests within 10 days before chemotherapy
- Left ventricular ejection fraction above 50%
- Adequate respiratory function with oxygen saturation above 92% on room air
- Willingness to undergo required blood collections and biopsies
- Willingness to stay within about 100 miles of the study site for 4 weeks after cell infusion
You will not qualify if you...
- Have active disease as defined by RECIST v1.1
- Pregnant, breastfeeding, or planning to conceive during the study and 6 months after cell infusion
- Received systemic anticancer therapy within 2 weeks or 3 half-lives prior to chemotherapy start
- Not fully recovered from prior treatment side effects above Grade 1 except certain mild conditions
- Received radiotherapy within 2 weeks prior to chemotherapy start or have unresolved radiation side effects
- Received live vaccines within 6 weeks before infusion or planned for 24 months after
- Prior genetically modified T or NK cell therapy
- Have immunodeficiency or on high-dose chronic steroids
- History of a second cancer unless cured for 2 years, with some exceptions
- Active autoimmune disease needing recent systemic treatment
- History or current interstitial lung disease or pneumonitis
- Active infection requiring systemic therapy
- Known HIV, active or chronic hepatitis B or C
- Active tuberculosis history
- Conditions or therapies interfering with study participation or safety
- Psychiatric or substance abuse disorders affecting cooperation
- History of allogeneic tissue or organ transplant
- Significant cardiovascular disease within 12 months
- Prolonged QT interval unless cleared by cardiology
- Bleeding or clotting disorders or at risk of severe hemorrhage, except treated deep vein thrombosis or pulmonary embolism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Maria Pia Morelli, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here