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

Last updated: January 28, 2026
Sponsor: Chimeric Therapeutics
Overall Status: Active - Recruiting

Phase

1/2

Condition

Gastric Cancer

Stomach Cancer

Colon Cancer; Rectal Cancer

Treatment

CHM-2101 CAR-T cells

Clinical Study ID

NCT06055439
CHM-2101-001
  • Ages 18-85
  • All Genders

Study Summary

The 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Documented informed consent of the participant and/or legally authorizedrepresentative.

  2. Confirmed histologic diagnosis of one of the following solid tumors of GI origin:

  3. Gastric adenocarcinoma Note: for gastric adenocarcinoma patients only, centrallaboratory confirmation of CDH17+ tumor expression is required.

  4. Colon and/or rectal adenocarcinoma

  5. G1, G2, and well-differentiated G3 neuroendocrine tumors of the midgut andhindgut (ileal, jejunal, cecal, distal colonic, or rectal; with ≤ 55% Ki67expression)

  6. Availability of unstained tumor tissue slides from archived tumor tissue or a newtumor biopsy, if medically feasible. Note: for gastric adenocarcinoma patients only,confirmation of CDH17+ is required prior to study inclusion.

  7. Have received at least 1 prior line of systemic anti-cancer treatment in the locallyadvanced or metastatic setting, as defined by National Comprehensive Cancer Network (NCCN) guidelines. Participants must have received or declined FDA-approved andavailable treatment options, including targeted therapies for disease mutation orantigen expression status.

  8. Age ≥ 18 years and ≤ 85 years.

  9. For Phase 1 Dose Expansion and Phase 2 only: Measurable disease as per RECIST v1.1criteria (Note: Measurable disease is NOT required for Phase 1 Dose Escalation).

  10. Eastern Cooperative Oncology Group (ECOG) ≤ 1.

  11. Life expectancy ≥ 12 weeks.

  12. No known contraindications to leukapheresis, cyclophosphamide, fludarabine, orsteroids.

  13. Baseline laboratory values as shown in the following table: Minimum Laboratory Values for Study Entry Laboratory Assessment Criteria White bloodcell 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 ULNCreatinine clearance by Cockroft-Gault equation 60 mL/min Oxygen saturation ≥ 92% onroom air Albumin ≥ 3 g/dL

  14. Left ventricular ejection fraction ≥ 50%.

  15. Seronegative for human immunodeficiency virus (HIV) by antigen/antibody (Ag/Ab)testing.

  16. Seronegative for hepatitis B and/or hepatitis C virus.

  17. Women of childbearing potential (WOCBP) must have a negative urine or serumpregnancy test. If the urine test is positive or cannot be confirmed as negative, aserum pregnancy test is required.

  18. Agreement by women and men of childbearing potential to use an effective method ofbirth control or abstain from heterosexual activity through at least 3 months afterthe last dose of CHM-2101.

Exclusion

Exclusion Criteria:

  1. Previous treatment with CDH17-targeted therapies.

  2. Unresolved toxicities from prior therapy except for chronic toxicity no greater thanGrade 1 and stable > 30 days (Note: alopecia of any grade is not exclusionary).

  3. Uncontrolled seizure activity and/or known central nervous system (CNS) metastases.

  4. History of allergic reactions attributed to compounds of similar chemical orbiologic composition to study agent.

  5. Uncontrolled Crohn's disease, ulcerative colitis, or other autoimmune orinflammatory disorders of the GI tract. "Uncontrolled" is defined as requiringhospitalization, corticosteroids, or chronic medication increase (dosage orfrequency) within the previous 6 months.

  6. Liver involvement ≥ 50%.

  7. Active infection requiring oral or IV antibiotics.

  8. Current diagnosis of pleural effusions, interstitial lung disease, or heart failureof New York Heart Association Classification of Heart Failure Class III or IV.

  9. Ongoing treatment with systemic corticosteroid therapy at doses of prednisone ≥ 20mg/day or equivalent (lower doses of corticosteroid therapy are allowed until 7 daysprior to leukapheresis).

  10. No prior malignancy within 5 years except for non-melanomatous skin cancer orcervical cancer treated with curative intent

  11. Currently breastfeeding or planning to become pregnant within 9 months of studyenrollment.

  12. Any other clinically significant uncontrolled illness or other comorbid conditionthat would, in the investigator's judgment, contraindicate the participant'sparticipation in the clinical study.

Study Design

Total Participants: 135
Treatment Group(s): 1
Primary Treatment: CHM-2101 CAR-T cells
Phase: 1/2
Study Start date:
May 15, 2024
Estimated Completion Date:
May 31, 2027

Study Description

This is a Phase 1/2 open-label study 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.

The study has 2 parts: Phase 1, Dose Escalation and Expansion, and Phase 2. Potential participants will provide written consent and be screened for study eligibility prior to undergoing any screening procedures, including leukapheresis. Protocol-specified criteria must be met prior to the start of leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). Eligible participants will undergo leukapheresis to collect PBMCs for product manufacturing, which comprises enrichment of T cells, lentiviral transduction, ex vivo expansion, and cryopreservation of the CHM-2101 cell product. Participants who have a leukapheresis or manufacturing failure may be permitted a second attempt at leukapheresis.

Bridging chemotherapy (treatment between the time of leukapheresis and first dose of lymphodepleting chemotherapy [LDC]) is permitted at the discretion of the investigator, if needed to maintain disease stability during CHM-2101 manufacturing time. Bridging chemotherapy is prohibited within the 2 weeks prior to leukapheresis and 2 weeks prior to planned CHM-2101 infusion. Specific criteria to proceed should be reviewed prior to leukapheresis, LDC, and CHM-2101 infusion. Participants will be followed in this study for 18 months or until disease progression.

Connect with a study center

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Emory University

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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