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 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 18 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will be followed in this study for 18 months or until disease progression."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests CHM-2101, a treatment made from a person's own immune cells that are changed to attack cancer. It is for adults with certain advanced cancers of the digestive system that came back or did not respond to at least one standard treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18 to 85 years old. You or your legal representative must give consent to join.
- Have a confirmed stomach, colon, or rectal adenocarcinoma (a cancer of gland cells), or certain neuroendocrine tumors (cancers of hormone-making cells) in the intestines.
- Provide stored tumor tissue or a new sample, if medically possible. Stomach cancer must test positive for the CDH17 protein.
- Have had at least one drug treatment for cancer that has spread nearby or to other parts of the body. You must have tried or declined available FDA-approved treatments.
- Be able to do most daily activities and be expected to live at least 12 weeks. Some parts of the study require cancer that can be measured on scans.
- Meet blood count, liver, kidney, oxygen, and heart test requirements. Be able to safely have blood cells collected and receive the required medicines.
- Test negative for HIV, hepatitis B, and hepatitis C.
- If able to become pregnant, have a negative pregnancy test. People who can have children must use effective birth control or avoid sex that could cause pregnancy until at least 3 months after the last dose.
Who can't join
- Have had treatment targeting CDH17, or have had an allergic reaction to a treatment similar to the study drug.
- Still have side effects from past treatment, unless they are mild and have been stable for more than 30 days. Hair loss is allowed.
- Have uncontrolled seizures or cancer that has spread to the brain or spinal cord.
- Have uncontrolled Crohn's disease, ulcerative colitis, or another immune or swelling disorder of the digestive tract. This includes needing hospital care, steroids, or an increase in regular medicine within the past 6 months.
- Have cancer involving at least half of the liver, an active infection needing antibiotics, fluid around the lungs, interstitial lung disease (a disorder affecting lung tissue), or severe heart failure.
- Take prednisone at 20 mg a day or more, or a similar steroid dose. Lower doses are allowed only until 7 days before blood cell collection.
- Have had another cancer within 5 years, except non-melanoma skin cancer or cervical cancer treated with the goal of a cure.
- Are breastfeeding, plan to become pregnant within 9 months of joining, or have another uncontrolled illness that the study doctor believes makes joining unsafe.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Documented informed consent of the participant and/or legally authorized representative. 2. Confirmed histologic diagnosis of one of the following solid tumors of GI origin: 1. Gastric adenocarcinoma Note: for gastric adenocarcinoma patients only, central laboratory confirmation of CDH17+ tumor expression is required. 2. Colon and/or rectal adenocarcinoma 3. G1, G2, and well-differentiated G3 neuroendocrine tumors of the midgut and hindgut (ileal, jejunal, cecal, distal colonic, or rectal; with ≤ 55% Ki67 expression) 3. 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. 4. 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. 5. Age ≥ 18 years and ≤ 85 years. 6. 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). 7. Eastern Cooperative Oncology Group (ECOG) ≤ 1. 8. Life expectancy ≥ 12 weeks. 9. No known contraindications to leukapheresis, cyclophosphamide, fludarabine, or steroids. 10. 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 11. Left ventricular ejection fraction ≥ 50%. 12. Seronegative for human immunodeficiency virus (HIV) by antigen/antibody (Ag/Ab) testing. 13. Seronegative for hepatitis B and/or hepatitis C virus. 14. 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. 15. 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. Exclusion Criteria: 1. Previous treatment with CDH17-targeted therapies. 2. 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). 3. Uncontrolled seizure activity and/or known central nervous system (CNS) metastases. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent. 5. 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. 6. Liver involvement ≥ 50%. 7. Active infection requiring oral or IV antibiotics. 8. Current diagnosis of pleural effusions, interstitial lung disease, or heart failure of New York Heart Association Classification of Heart Failure Class III or IV. 9. 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). 10. No prior malignancy within 5 years except for non-melanomatous skin cancer or cervical cancer treated with curative intent 11. Currently breastfeeding or planning to become pregnant within 9 months of study enrollment. 12. 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.
Study sites (4)
GA
- Emory University · Atlanta, GA 30322Daniel M Halperin, MD · Principal investigatorMore trials in Atlanta
IL
- University of Chicago · Chicago, IL 60637Daniel Olson, MD · Principal investigatorMore trials in Chicago
PA
- University of Pennsylvania · Philadelphia, PA 19104Jennifer Eads, MD · Principal investigatorMore trials in Philadelphia
TN
- Sarah Cannon Research Institute · Nashville, TN 37203Meredith Pelster, MD · Principal investigatorMore trials in Nashville