Clinical trialPhase 1Unknown
A Phase I Trial to Evaluate the Safety of IMC002 in Advanced Digestive System Tumors
A Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of IMC002 in Patients With Claudin18.2-positive Advanced Digestive System Tumors
- Outcome
- Outcome unknown
- Cell product
- CAR-T cells
Biological: IMC002 injection (Autologous Claudin 18.2 specific CAR-T cell injection)
- Target antigen
- CLDN18.2
A Phase I, Open-label, Multi-center, Dose-escalation Study to Evaluate the Safety, Feasibility, and Preliminary Efficacy of IMC002 in Patients With Claudin18.2-positive Advanced Digestive System Tumors
- Cell source
- Autologous
Biological: IMC002 injection (Autologous Claudin 18.2 specific CAR-T cell injection)
- Lymphodepletion
- Cyclophosphamide + fludarabine
After treatment with cyclophosphamide, fludarabine and nab-paclitaxel lymphodepletion, patients will be assigned to one of three dose escalation cohorts 1.0×108, 2.5×108, or 5.0×108 CAR-T cells.
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 7 September 2023
- Listed end
- 31 December 2025
- Enrollment
- 18 participants
- Sites
- 7
- Primary outcomes
- Incidence and severity of dose-limiting toxicity (DLTs) within 28 days after IMC002 infusion
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 28 September 2023
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
This is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer.
Detailed description public domain (ClinicalTrials.gov)
This is an open-label, multi-center, dose-escalation clinical study to evaluate the safety, feasibility, and preliminary efficacy of IMC002 in patients with CLDN18.2 positive digestive system tumors including but not limited to advanced gastric cancer, esophagogastric junction adenocarcinoma, and advanced pancreatic cancer. Approximately 9-18 patients with CLDN18.2-positive advanced digestive system tumors will be sequentially enrolled into 3 dose escalation cohorts to evaluate the safety and feasibility of autologous IMC002 treatment. Following enrolment, patients will undergo leukapheresis and IMC002 product preparation. Patients may receive bridging therapies if the disease progresses rapidly as determined by the investigator. After treatment with cyclophosphamide, fludarabine and nab-paclitaxel lymphodepletion, patients will be assigned to one of three dose escalation cohorts 1.0×108, 2.5×108, or 5.0×108 CAR-T cells. All patients will be given a single dose of IMC002 infusion. All patients will be followed as inpatient for 14 days. When all patients of a cohort have been observed for 28 days and no DLT criteria have been met, patients will be enrolled in next higher dose cohort. All enrolled patients will follow the same study treatment schedule and procedural requirements. This study is divided into a screening period, a lymphodepleting (LD) chemotherapy period, a treatment period, a primary follow-up period up to 12 weeks and a long-term follow-up period for up to 15 years post infusion.
Intervention public domain (ClinicalTrials.gov)
Biological: IMC002 injection (Autologous Claudin 18.2 specific CAR-T cell injection). three different IMC002 Doses will be escalated in "3+3" design
Arm public domain (ClinicalTrials.gov)
IMC002 dose 1-3 (experimental): IMC002 single infusion