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CAR T-cell Therapy

CAR-T Cell Therapy for Gastrointestinal Cancers

Phase 1 & 2

Recruiting

Led By Meredith Pelster, MD

Research Sponsored by Chimeric Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received at least 1 prior line of systemic anti-cancer treatment in the locally advanced or metastatic setting

Eastern Cooperative Oncology Group (ECOG) score of 1 or less

Must not have

Prior malignancy within 5 years except for specified exceptions

Liver involvement of 50% or more

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new treatment called CHM-2101, which uses a patient's own modified immune cells to target and treat advanced gastrointestinal cancers that have not responded to standard treatments.

Who is the study for?

This trial is for adults aged 18-85 with advanced GI cancers, including neuroendocrine tumors and colorectal or stomach cancer, that didn't respond to at least one standard treatment. Participants must have measurable disease (except in early phase), provide tissue samples, and be physically able to undergo the therapy.

What is being tested?

CHM-2101 CAR-T cell therapy is being tested on patients with specific gastrointestinal cancers. This personalized treatment involves modifying a patient's own immune cells to target and destroy cancer cells.

What are the potential side effects?

CAR-T cell therapies like CHM-2101 can cause side effects such as fever, fatigue, low blood pressure, difficulty breathing, rapid heartbeat, and may lead to more serious conditions affecting different organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least one treatment for cancer that has spread.

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I am fully active or can carry out light work.

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I have been diagnosed with a specific type of stomach, colon, rectal cancer, or a certain neuroendocrine tumor.

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I am between 18 and 85 years old.

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I have no allergies or adverse reactions to specific cancer treatments or procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had any cancer except for certain types in the last 5 years.

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Half or more of my liver is affected by cancer.

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I am currently taking antibiotics for an infection.

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I am currently on high-dose corticosteroid therapy.

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I have not been treated with CDH17-targeted therapies before.

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I have been diagnosed with severe heart failure or lung problems.

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I have seizures or brain metastases that are not under control.

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I do not have uncontrolled Crohn's, ulcerative colitis, or similar GI disorders.

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I do not have any severe illnesses that would prevent me from joining.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

All other adverse events and toxicities

Dose-Limiting Toxicity (DLT)

Objective Response Rate (ORR)

+1 more

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Autologous CDH17 CAR T-cell TherapyExperimental Treatment1 Intervention

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.

0 / 14Eligibility criteria met