Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

Sponsor
CARsgen Therapeutics Co., Ltd.
Study ID
NCT04581473
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Oct 23, 2020
Status verified
Jun 2025
Primary completion
Oct 18, 2024
Completion
Jun 30, 2038

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CT041 autologous CAR T-cell injection
    Two stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety
  • Active Comparator: Physician's Choice
    Participants will receive physician's choice of treatment in Phase II

Primary Outcome Measure

Phase Ib: Incidence of Treatment Related adverse events (AEs) [ Time Frame: Up to 18 months ]

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