Clinical trialEarly Phase 1Recruiting
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Gastrointestinal Tumors
- Outcome
- Ongoing
- Phase
- Early Phase 1
- Status
- Recruiting
- Study type
- Interventional
- Start
- 9 October 2023
- Expected end
- 19 July 2027
- Enrollment
- 14 participants
- Sites
- 1
- Primary outcomes
- Dose-Limiting Toxicity (DLT); Maximum tolerated dose; AE, SAE, AESI, CRS, ICANS, TEAE
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 1 December 2023
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Brief summary public domain (ClinicalTrials.gov)
This study is an exploratory single-arm, open, modified "3+3" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent/refractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection. Four dose levels were designed for this study: 1.0×10\^8cells, 3.0×10\^8cells, 1.0×10\^9cells, and 3.0×10\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent/refractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.
Detailed description public domain (ClinicalTrials.gov)
Main research objectives: Evaluation of the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors Secondary research objectives: 1. Evaluate the pharmacokinetic (PK) characteristics of BGT007H cells after reinfusion; 2. Evaluation of the initial effectiveness of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors Exploratory Purpose 1. Exploring the correlation between the proliferation and survival of BGT007H cells in vivo and their therapeutic effects; 2. Exploring the correlation between target expression levels and efficacy