Actively Recruiting
Phase 12 Study of CHM-2101, a Personalized CDH17 CAR T-Cell Therapy for Advanced Gastrointestinal Cancers Resistant to Previous Treatments
Led by Chimeric Therapeutics · Updated on 2026-01-29
135
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying CHM-2101, an autologous CDH17 CAR T-cell therapy, in a Phase 12 open-label trial for patients with advanced gastrointestinal cancers that have returned or not responded to at least one standard treatment in metastatic or locally advanced stages. The study aims to evaluate the safety and effects of this therapy in treating gastric adenocarcinoma, colorectal cancer, and certain neuroendocrine tumors. It is sponsored by Chimeric Therapeutics and focuses on patients who have undergone prior treatments. The trial includes two parts Phase 1 with dose escalation and expansion, and Phase 2. Participants first provide consent and undergo screening before leukapheresis, a procedure to collect immune cells for manufacturing the CHM-2101 therapy. After cell collection, participants may receive bridging chemotherapy to maintain disease stability if needed. Treatment involves three daily intravenous doses of fludarabine and cyclophosphamide followed by a single intravenous infusion of CHM-2101. The dose in Phase 1 follows a 33 escalation design to determine the recommended dose for Phase 2. Participants will be monitored for up to 18 months or until their disease progresses. Assessments include safety evaluations focusing on dose-limiting toxicities, cytokine release syndrome, adverse events, and objective tumor response. Secondary outcomes include disease control, response duration, and survival measures. Laboratory tests, imaging, and clinical evaluations will be used to follow participants health and treatment effects throughout the study.
CONDITIONS
Brief 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...
- Provided documented informed consent.
- Confirmed diagnosis of gastric adenocarcinoma, colon or rectal adenocarcinoma, or certain well-differentiated neuroendocrine tumors of the midgut and hindgut.
- For gastric adenocarcinoma, tumor must express CDH17 confirmed by central lab.
- Availability of tumor tissue slides or biopsy for analysis.
- Received at least one prior systemic anti-cancer treatment in locally advanced or metastatic setting.
- Age between 18 and 85 years.
- Measurable disease required for Phase 1 Dose Expansion and Phase 2; not required for Phase 1 Dose Escalation.
- Eastern Cooperative Oncology Group (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 blood counts, liver enzymes, kidney function, oxygen saturation, and albumin.
- Left ventricular ejection fraction of 50% or higher.
- Seronegative for HIV and hepatitis B and 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 central nervous system metastases.
- Allergic reactions to similar biological compounds.
- Uncontrolled autoimmune or inflammatory GI disorders requiring recent hospitalization or medication increase.
- Liver involvement of 50% or more.
- Active infection requiring oral or IV antibiotics.
- Current pleural effusions, interstitial lung disease, or severe heart failure (Class III or IV).
- Ongoing systemic corticosteroid therapy at prednisone 20 mg/day or higher (lower doses allowed until 7 days before leukapheresis).
- Prior malignancy within 5 years except certain skin or cervical cancers treated curatively.
- Currently breastfeeding or planning pregnancy within 9 months.
- Other clinically significant uncontrolled illnesses or conditions that contraindicate participation.
Research Team
C
Chimeric Clinical
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here