Health Trials

About this trial

This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic colorectal cancer (CRC). Participants are assigned to one of three dual-target arms based on tumor antigen co-expression: (1) CEA+GUCY2C, (2) CEA+HER2, or (3) GUCY2C+HER2. Following dose escalation, the most suitable target pair (based on safety, feasibility, and early efficacy/biomarker signals) will be selected for dose expansion.

Eligibility criteria

Qualifiers

Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible for standard therapies.

Measurable disease per RECIST v1.1 (unless in minimal residual disease (MRD) or post-resection cohorts if a future amendment is planned).

Tumor antigen co-expression meeting central lab thresholds for one of the following pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2.

ECOG performance status 0-1.

Disqualifiers

Active, uncontrolled infection (including uncontrolled HBV/HCV) or known uncontrolled HIV infection.

Active CNS metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.)

Prior gene-modified cellular therapy (CAR-T/CAR-NK/TCR-T) within 6 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.

Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.

Trial design

Treatments tested in this trial

  • EB-DUO-CAR-NK-CEA/GCC
  • Lymphodepletion

Treatment groups

48 Participants
are divided into 3 treatment groups

Locations

1
Peking University Shenzhen Hospital518036, ShenzhenGuangdong, China

Sponsors and collaborators

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov