Clinical trialPhase 1Unknown
A Study of IMC008 for Advanced Solid Tumors
A Clinical Study on the Safety and Preliminary Efficacy of IMC008 in the Treatment of CLDN18.2- Positive Advanced Solid Tumors
- Outcome
- Outcome unknown
- Cell product
- Other cell therapies
Drug: IMC008 (NKG2D receptor-modified autologous CAR -T cells targeting CLDN18.2)
- Target antigen
- CLDN18.2, NKG2D ligands
A Clinical Study on the Safety and Preliminary Efficacy of IMC008 in the Treatment of CLDN18.2- Positive Advanced Solid Tumors … Drug: IMC008 (NKG2D receptor-modified autologous CAR -T cells targeting CLDN18.2)
- Cell source
- Autologous
Drug: IMC008 (NKG2D receptor-modified autologous CAR -T cells targeting CLDN18.2)
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 2 April 2023
- Listed end
- 31 March 2026
- Enrollment
- 18 participants
- Sites
- 1
- Primary outcomes
- DLT
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 1 May 2023
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Source text
Brief summary public domain (ClinicalTrials.gov)
An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.
Detailed description public domain (ClinicalTrials.gov)
This study is an open label, multi-center, dose-escalating clinical study to evaluate the safety and preliminary efficacy of IMC008 in the treatment of CLDN18.2 positive advanced solid tumors. DLTs observations will be performed 28 days after IMC008 administration. During the study, regular safety meetings will be held according to the progress of the study, and recommendations will be made on dose escalation, safety of subjects and possible study change.
Intervention public domain (ClinicalTrials.gov)
Drug: IMC008 (NKG2D receptor-modified autologous CAR -T cells targeting CLDN18.2). allowing 10% dose error
Arm public domain (ClinicalTrials.gov)
IMC008 dose 1-3 (experimental): a certain number of IMC008 cell per kg will be infused