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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Chimeric Therapeutics
Study ID
NCT06055439
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • CHM-2101 CAR-T cells — BIOLOGICAL
    Cadherin 17 (CDH17) Chimeric Antigen Receptor (CAR)-positive T cells

Study Details

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.

Key Dates

Start date
May 15, 2024
Status verified
Jan 2026
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
135 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Dose-Limiting Toxicity (DLT) [ Time Frame: 28 Days ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322
Daniel M Halperin, MD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Daniel Olson, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Jennifer Eads, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203
Meredith Pelster, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Colorectal cancerGastric cancerNeuroendocrine tumors
By specialty
OncologyGI oncology
By research site
Emory University· Atlanta, GAUniversity of Chicago· Chicago, ILUniversity of Pennsylvania· Philadelphia, PASarah Cannon Research Institute· Nashville, TN

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