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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Documented informed consent of the participant and/or legally authorized representative.

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

∙ Gastric adenocarcinoma Note: for gastric adenocarcinoma patients only, central laboratory confirmation of CDH17+ tumor expression is required.

‣ Colon and/or rectal adenocarcinoma

‣ G1, G2, and well-differentiated G3 neuroendocrine tumors of the midgut and hindgut (ileal, jejunal, cecal, distal colonic, or rectal; with ≤ 55% Ki67 expression)

• 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.

• 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.

• Age ≥ 18 years and ≤ 85 years.

• 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).

• Eastern Cooperative Oncology Group (ECOG) ≤ 1.

• Life expectancy ≥ 12 weeks.

• No known contraindications to leukapheresis, cyclophosphamide, fludarabine, or steroids.

⁃ 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

⁃ Left ventricular ejection fraction ≥ 50%.

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

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

⁃ 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.

⁃ 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.

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Illinois
University of Chicago
RECRUITING
Chicago
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Sarah Cannon Research Institute
RECRUITING
Nashville
Contact Information
Primary
Jason B Litten, MD
jlitten@chimerictherapeutics.com
(415) 802-4360
Time Frame
Start Date: 2024-05-15
Estimated Completion Date: 2027-05
Participants
Target number of participants: 135
Treatments
Experimental: Autologous CDH17 CAR T-cell Therapy
After receiving three daily doses of IV fludarabine and cyclophosphamide, participants will receive a single dose of IV CHM-2101.~The dose of CHM-2101 during Phase 1 will be based on 3+3 rules of dose escalation.~The recommended Phase 2 dose will be based on results from the Phase 1.
Sponsors
Leads: Chimeric Therapeutics

This content was sourced from clinicaltrials.gov