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Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllBeijing Biotech
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. * Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in protocol. * Recovered to Grade โ‰ค1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia). * Life expectancy โ‰ฅ 12 weeks. * Willingness to use effective contraception during study and for a protocol-defined period after cell infusion. Exclusion Criteria: * 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. * Concurrent anti-cancer therapy (other than protocol-permitted bridging) during the DLT window. * Pregnant or breastfeeding. * Significant cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia), uncontrolled pulmonary disease, or other severe comorbidity that would increase risk. * Known hypersensitivity to study chemotherapy components (fludarabine/cyclophosphamide) or required supportive medications. * Any condition that, in the investigator's opinion, would interfere with study participation, safety monitoring, or interpretation of results.
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What it tests

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

1 site
Peking University Shenzhen Hospital
Shenzhen, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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