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New treatment option for Neuroendocrine Tumors
Official title A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy
ClinicalTrials.gov ID: NCT06055439
What this study is testing
What is CHM-2101 CAR-T cells?
CHM-2101 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroendocrine tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Liver involvement ≥ 50%.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- 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...
- Liver involvement ≥ 50%.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Chicago, Illinois, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.