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

Inclusion Criteria

• •1. Documented informed consent of the participant and/or legally authorized representative.
• •2. Confirmed histologic diagnosis of one of the following solid tumors of GI origin:
• •1. Gastric adenocarcinoma Note: for gastric adenocarcinoma patients only, central laboratory confirmation of CDH17+ tumor expression is required.
• •2. Colon and/or rectal adenocarcinoma
• •3. G1, G2, and well-differentiated G3 neuroendocrine tumors of the midgut and hindgut (ileal, jejunal, cecal, distal colonic, or rectal; with ≤ 55% Ki67 expression)
• •3. Availability 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.
• •4. Have 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.
• •5. Age ≥ 18 years and ≤ 85 years.
• •6. For 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).
• •7. Eastern Cooperative Oncology Group (ECOG) ≤ 1.
• •8. Life expectancy ≥ 12 weeks.
• •9. No known contraindications to leukapheresis, cyclophosphamide, fludarabine, or steroids.
• •10. Baseline laboratory values as shown in the following table:
• •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
• •11. Left ventricular ejection fraction ≥ 50%.
• •12. Seronegative for human immunodeficiency virus (HIV) by antigen/antibody (Ag/Ab) testing.
• •13. Seronegative for hepatitis B and/or hepatitis C virus.
• •14. Women 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.
• •15. Agreement 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.