Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Tcelltech Inc.
Study ID
NCT06482905
Phase
PHASE1
Status
Recruiting
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Conditions

  • High-grade Glioma
  • WHO Grade Ⅳ Glioma

Eligibility Criteria

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

Interventions

  • Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103 — BIOLOGICAL
    Safety Run-In: Dose:6×10\^7 CAR+ T cells Cohort A Single delivery route(Multi-dose)、Cohort B Dual delivery route(Multi-dose)： 3+3 dose escalation design： Dose Level 1: 6×10\^7 CAR+ T cells Dose Level 2: 1.5×10\^8 CAR+ T cells Dose Level 3: 2.5×10\^8 CAR+ T cells

Study Details

This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.

Key Dates

Start date
Sep 4, 2024
Status verified
Apr 2025
Primary completion
Sep 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-In
    Single-dose administration of TX103 via intraventricular(ICV) or intracavitary (ICT) .
  • Experimental: Cohort A Single delivery route(Multi-dose)
    Administration of TX103 via intraventricular(ICV) on Days 1 and 8 in a 21-day treatment cycle.
  • Experimental: Cohort B Dual delivery route(Multi-dose)
    Administration of TX103 on Day 1 via intracavitary (ICT) and on Day 8 via intraventricular(ICV) in a 21-day treatment cycle.

Primary Outcome Measure

Safety：Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: 28 days after the first TX103 infusion. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaPhoenixArizona85054
Maciej M. Mrugala, M.D., Ph.D.
Mayo Clinic in FloridaJacksonvilleFlorida32224
Wendy J. Sherman, M.D.
Mayo Clinic in RochesterRochesterMinnesota55905
Lia Tipton, MD.,PhD.
[email protected]

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