Trials / Active Not Recruiting
Active Not RecruitingNCT04581473
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
An Open, Multicenter, Phase Ib/II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection in Patients With Advanced Gastric/ Gastroesophageal Junction Adenocarcinoma and Pancreatic Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- Sponsor
- CARsgen Therapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer
Detailed description
This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CT041 autologous CAR T-cell injection | Up to 3 times CT041 autologous CAR T-cell injection infusion |
| DRUG | Physician's Choice（Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody） | Physician's choice of any BSC listed above |
Timeline
- Start date
- 2020-10-23
- Primary completion
- 2024-10-18
- Completion
- 2038-06-30
- First posted
- 2020-10-09
- Last updated
- 2025-06-05
Locations
24 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04581473. Inclusion in this directory is not an endorsement.