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Neuroendocrine TumorsPhase 1/2NCT06055439

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

A Phase 1/2 study testing CHM-2101 CAR-T cells in people with Neuroendocrine Tumors and Colorectal Cancer, run by Chimeric Therapeutics at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
CHM-2101 CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
4 sitesUnited States
Study dates
15 May 2024to 31 Dec 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Previous treatment with CDH17-targeted therapies.
  • Unresolved toxicities from prior therapy except for chronic toxicity no greater than Grade 1 and stable > 30 days (Note: alopecia of any grade is not exclusionary).
  • Uncontrolled seizure activity and/or known central nervous system (CNS) metastases.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
  • Uncontrolled Crohn's disease, ulcerative colitis, or other autoimmune or inflammatory disorders of the GI tract. "Uncontrolled" is defined as requiring hospitalization, corticosteroids, or chronic medication increase (dosage or frequency) within the previous 6 months.
  • Liver involvement ≥ 50%.
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  • Active infection requiring oral or IV antibiotics.
  • Current diagnosis of pleural effusions, interstitial lung disease, or heart failure of New York Heart Association Classification of Heart Failure Class III or IV.
  • Ongoing treatment with systemic corticosteroid therapy at doses of prednisone ≥ 20 mg/day or equivalent (lower doses of corticosteroid therapy are allowed until 7 days prior to leukapheresis).
  • No prior malignancy within 5 years except for non-melanomatous skin cancer or cervical cancer treated with curative intent
  • Currently breastfeeding or planning to become pregnant within 9 months of study enrollment.
  • Any other clinically significant uncontrolled illness or other comorbid condition that would, in the investigator's judgment, contraindicate the participant's participation in the clinical study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Chicago

    Chicago, Illinois, 60637

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

This is a Phase 1/2 open-label study 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.

The study has 2 parts: Phase 1, Dose Escalation and Expansion, and Phase 2. Potential participants will provide written consent and be screened for study eligibility prior to undergoing any screening procedures, including leukapheresis. Protocol-specified criteria must be met prior to the start of leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). Eligible participants will undergo leukapheresis to collect PBMCs for product manufacturing, which comprises enrichment of T cells, lentiviral transduction, ex vivo expansion, and cryopreservation of the CHM-2101 cell product. Participants who have a leukapheresis or manufacturing failure may be permitted a second attempt at leukapheresis.

Bridging chemotherapy (treatment between the time of leukapheresis and first dose of lymphodepleting chemotherapy [LDC]) is permitted at the discretion of the investigator, if needed to maintain disease stability during CHM-2101 manufacturing time. Bridging chemotherapy is prohibited within the 2 weeks prior to leukapheresis and 2 weeks prior to planned CHM-2101 infusion. Specific criteria to proceed should be reviewed prior to leukapheresis, LDC, and CHM-2101 infusion. Participants will be followed in this study for 18 months or until disease progression.

Being tested
CHM-2101 CAR-T cells
Medical subject headings
Neuroendocrine Tumors, Colorectal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHM-2101 CAR-T cellsBiological

    Cadherin 17 (CDH17) Chimeric Antigen Receptor (CAR)-positive T cells

Study groups in NCT06055439
Study groupRoleWhat they receive
Autologous CDH17 CAR T-cell TherapyExperimentalAfter 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.
Receives: Biological: CHM-2101 CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT)

    Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

    Measured: 28 Days

  2. Rates and Grades of Cytokine Release Syndrome (CRS)

    Assessed per American Society for Transplant and Cellular Therapy (ASTCT) consensus grading guideline

    Measured: up to 15 years

  3. All other adverse events and toxicities

    Assessed per NCI CTCAE v5.0

    Measured: up to 15 years

  4. Objective Response Rate (ORR)

    Assessed by RECIST v 1.1

    Measured: up to 15 years

Secondary outcomes (5)

  1. Disease control rate (DCR)

    Assessed as the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, and stable disease to a therapeutic intervention in clinical trials of anticancer agents.

    Measured: up to 15 years

  2. Time to response (TTR)

    Measured as the amount of time elapsed until drug response is achieved for the first time.

    Measured: up to 15 years

  3. Duration of response (DOR)

    Measured as the amount of time a patient responds to a treatment before disease progresses or the patient dies.

    Measured: up to 15 years

  4. Progression-free survival (PFS)

    Measured from the date of first infusion of CAR-T cells until the first date when progressive disease (PD) is objectively documented or death from any cause, whichever is earlier.

    Measured: up to 15 years

  5. Overall survival (OS)

    Measured from the date of first infusion of CAR-T cells until death.

    Measured: up to 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start15 May 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06055439
Sponsor's protocol ID
CHM-2101-001
Status last verified
Oct 2026
First submitted
13 Sep 2023
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CHM-2101 CAR-T cells in people with Neuroendocrine Tumors and Colorectal Cancer, run by Chimeric Therapeutics at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: 28 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06055439.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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