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OncoMatch/Clinical Trials/NCT06055439

A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy

Is NCT06055439 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies CHM-2101 CAR-T cells for neuroendocrine tumors.

Phase 1/2RecruitingChimeric TherapeuticsNCT06055439Data as of Jun 2026

Treatment: CHM-2101 CAR-T cellsThe goal of this clinical trial is to evaluate CHM-2101, an autologous CDH17 CAR T-cell therapy for the treatment of advanced gastrointestinal (GI) cancers that are relapsed or refractory to at least 1 standard treatment regimen in the metastatic or locally advanced setting.

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Extracted eligibility criteria

Treatments studied

Other

CHM-2101 CAR-T cells

Cancer type

Neuroendocrine Tumor

Colorectal Cancer

Gastric Cancer

Biomarker criteria

Required: CDH17 overexpression (CDH17+)

for gastric adenocarcinoma patients only, central laboratory confirmation of CDH17+ tumor expression is required

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 85

Prior therapy

Min 1 prior line

Must have received: systemic anti-cancer treatment — locally advanced or metastatic

Have received at least 1 prior line of systemic anti-cancer treatment in the locally advanced or metastatic setting

Cannot have received: CDH17-targeted therapy

Previous treatment with CDH17-targeted therapies

Lab requirements

Blood counts

White blood cell count > 4,000/mm3; ANC ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 10 g/dL

Kidney function

Creatinine clearance by Cockroft-Gault equation 60 mL/min

Liver function

Total bilirubin ≤ 1.5 x ULN; AST ≤ 3 x ULN; ALT ≤ 3 x ULN; Albumin ≥ 3 g/dL

Cardiac function

Left ventricular ejection fraction ≥ 50%

Minimum Laboratory Values for Study Entry Laboratory Assessment Criteria White blood cell count > 4,000/mm3 Absolute neutrophil count (ANC) ≥ 1,500/mm3 Platelets ≥ 100,000/mm3 Hemoglobin ≥ 10 g/dL Total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate amino transferase (AST) ≤ 3 x ULN Alanine transaminase (ALT) ≤ 3 x ULN Creatinine clearance by Cockroft-Gault equation 60 mL/min Oxygen saturation ≥ 92% on room air Albumin ≥ 3 g/dL; Left ventricular ejection fraction ≥ 50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Emory University · Atlanta, Georgia
  • University of Chicago · Chicago, Illinois
  • University of Pennsylvania · Philadelphia, Pennsylvania
  • Sarah Cannon Research Institute · Nashville, Tennessee

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06055439 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CDH17-targeted therapy disqualifies patients from enrollment.

Does this trial require CDH17?

Yes, CDH17 overexpression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 85 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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