Actively Recruiting
A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy
Led by Chimeric Therapeutics · Updated on 2026-01-29
135
Participants Needed
4
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from participant or legal representative
- Confirmed diagnosis of gastric adenocarcinoma, colorectal adenocarcinoma, or certain midgut/hindgut neuroendocrine tumors with 3% Ki67 expression
- Availability of tumor tissue slides or biopsy for CDH17 testing (required for gastric adenocarcinoma)
- Received at least one prior systemic anti-cancer treatment in advanced or metastatic setting
- Age between 18 and 85 years
- Measurable disease per RECIST v1.1 for Phase 1 Dose Expansion and Phase 2 (not required for Phase 1 Dose Escalation)
- ECOG performance status of 0 or 1
- Life expectancy of at least 12 weeks
- No contraindications to leukapheresis, cyclophosphamide, fludarabine, or steroids
- Adequate baseline laboratory values including white blood cell count, neutrophil count, platelets, hemoglobin, liver enzymes, creatinine clearance, oxygen saturation, and albumin
- Left ventricular ejection fraction of at least 50%
- Seronegative for HIV, hepatitis B, and hepatitis C
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control or abstain from heterosexual activity during and for 3 months after treatment
You will not qualify if you...
- Previous treatment with CDH17-targeted therapies
- Unresolved toxicities from prior therapies above Grade 1 except alopecia
- Uncontrolled seizures or known CNS metastases
- Allergic reactions to similar compounds as study agent
- Uncontrolled Crohn's disease, ulcerative colitis, or other autoimmune/inflammatory GI disorders requiring recent hospitalization or medication increase
- Liver involvement of 50% or more
- Active infections needing antibiotics
- Diagnosis of pleural effusions, interstitial lung disease, or severe heart failure (NYHA Class III or IV)
- Ongoing high-dose systemic corticosteroids (prednisone 6 20 mg/day) within 7 days before leukapheresis
- Prior malignancy within 5 years except certain treated skin or cervical cancers
- Currently breastfeeding or planning pregnancy within 9 months
- Other significant uncontrolled illnesses or conditions that contraindicate participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
C
Chimeric Clinical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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