Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced/Metastatic Solid Tumors
NCT05693844 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2024-05-10
Summary
In preclinical study, investigators have demonstrated that the newly developed pan-T booster (harbouring CD40 agonist and one T cell costimulator agonist) co-expressing MSLN CAR T cell possess more powerful antitumor activity than previously reported MSLN-CAR T cells. In this clinical trial, enrolled patients receive an initial dose of pan-T booster co-expressing MSLN CAR T cells at 1×10\^6 cells/kg based on the basic principle of dose escalation design, in order to evaluate the safety, feasibility, pharmacokinetics/pharmacodynamics, and efficacy of pan-T booster co-expressing MSLN CAR T cell in vivo.
Conditions
- Advanced or Metastatic Solid Tumors
Interventions
- BIOLOGICAL
-
Pan-T booster co-expressing MSLN CAR T cell
Starting Dose: 1×10\^6 cells/kg
- DRUG
-
Albumin-bound paclitaxel
Administered intravenously at dose of 100-200mg/m2 on day -5
- DRUG
-
Administered intravenously at a total dose of 15-30mg/kg on day -3 and day -2
- DRUG
-
Administered intravenously at dose of 30mg/m2/d on day -3 and day -2
Sponsors & Collaborators
-
UTC Therapeutics Inc.
collaborator INDUSTRY -
Chinese PLA General Hospital
lead OTHER
Principal Investigators
-
Yangbin Zhao, PhD · UTC Therapeutics Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-20
- Primary Completion
- 2025-12-31
- Completion
- 2026-12-31
Countries
- China
Study Locations
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