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Official Title

A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 (CDH17) Chimeric Antigen Receptor (CAR) T Cell Therapy for the Treatment of Relapsed or Refractory Gastrointestinal Cancers

Phase
Phase 1/Phase 2
Sponsor
Chimeric Therapeutics
Enrollment
135
Timeline
May 2024 → May 2027
About This Study

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 Criteria

  • 1Documented informed consent of the participant and/or legally authorized representative.
  • 2Confirmed histologic diagnosis of one of the following solid tumors of GI origin:
  • 3Gastric adenocarcinoma Note: for gastric adenocarcinoma patients only, central laboratory confirmation of CDH17+ tumor expression is required.
  • 4Colon and/or rectal adenocarcinoma
  • 5G1, G2, and well-differentiated G3 neuroendocrine tumors of the midgut and hindgut (ileal, jejunal, cecal, distal colonic, or rectal; with ≤ 55% Ki67 expression)
  • 6Availability of unstained tumor tissue slides from archived tumor tissue or a new tumor biopsy, if medically feasible. Note: for gastric adenocarcinoma patients only, confirmation of CDH17+ is required prior to study inclusion.
  • 7Have received at least 1 prior line of systemic anti-cancer treatment in the locally advanced or metastatic setting, as defined by National Comprehensive Cancer Network (NCCN) guidelines. Participants must have received or declined FDA-approved and available treatment options, including targeted therapies for disease mutation or antigen expression status.
  • 8Age ≥ 18 years and ≤ 85 years.
  • 9For Phase 1 Dose Expansion and Phase 2 only: Measurable disease as per RECIST v1.1 criteria (Note: Measurable disease is NOT required for Phase 1 Dose Escalation).
  • 10Eastern Cooperative Oncology Group (ECOG) ≤ 1.
  • 11Life expectancy ≥ 12 weeks.
  • 12No known contraindications to leukapheresis, cyclophosphamide, fludarabine, or steroids.
  • 13Baseline laboratory values as shown in the following table:
  • 14Minimum 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
  • 15Left ventricular ejection fraction ≥ 50%.
  • 16Seronegative for human immunodeficiency virus (HIV) by antigen/antibody (Ag/Ab) testing.
  • 17Seronegative for hepatitis B and/or hepatitis C virus.
  • 18Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.
  • 19Agreement by women and men of childbearing potential to use an effective method of birth control or abstain from heterosexual activity through at least 3 months after the last dose of CHM-2101.

Exclusion Criteria

  • 1Previous treatment with CDH17-targeted therapies.
  • 2Unresolved toxicities from prior therapy except for chronic toxicity no greater than Grade 1 and stable \> 30 days (Note: alopecia of any grade is not exclusionary).
  • 3Uncontrolled seizure activity and/or known central nervous system (CNS) metastases.
  • 4History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
  • 5Uncontrolled Crohn's disease, ulcerative colitis, or other autoimmune or inflammatory disorders of the GI tract. "Uncontrolled" is defined as requiring hospitalization, corticosteroids, or chronic medication increase (dosage or frequency) within the previous 6 months.
  • 6Liver involvement ≥ 50%.
  • 7Active infection requiring oral or IV antibiotics.
  • 8Current diagnosis of pleural effusions, interstitial lung disease, or heart failure of New York Heart Association Classification of Heart Failure Class III or IV.
  • 9Ongoing treatment with systemic corticosteroid therapy at doses of prednisone ≥ 20 mg/day or equivalent (lower doses of corticosteroid therapy are allowed until 7 days prior to leukapheresis).
  • 10No prior malignancy within 5 years except for non-melanomatous skin cancer or cervical cancer treated with curative intent
  • 11Currently breastfeeding or planning to become pregnant within 9 months of study enrollment.
  • 12Any other clinically significant uncontrolled illness or other comorbid condition that would, in the investigator's judgment, contraindicate the participant's participation in the clinical study.

Locations

4 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Daniel M Halperin, MD

University of Chicago

Chicago, Illinois 60637

Recruiting

Daniel Olson, MD

University of Pennsylvania

Philadelphia, Pennsylvania 19104

Recruiting

Jennifer Eads, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →