Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas

Sponsor
Shenzhen Geno-Immune Medical Institute
Study ID
NCT03356782
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Ewing Sarcoma
  • Osteoid Sarcoma
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Sarcoma-specific CAR-T cells — BIOLOGICAL
    1 infusion, for 1x10\^6\~1x10\^7 cells/kg via IV

Study Details

The aim of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cells immunotherapy in patients who have sarcoma that is relapsed or late staged. Another goal of the study is to assess the safety and efficacy of the therapy that combines CAR T cells and IgT cells to treat sarcoma.

Key Dates

First listed
Nov 29, 2017
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sarcoma-specific CAR-T cells
    Peripheral blood mononuclear cells (PBMCs) of patients who have CD133, GD2, Muc1, CD117 or other marker positive sarcoma will be obtained through apheresis, and T cells will be activated and modified to sarcoma-specific CAR-T cells.

Primary Outcome Measure

Safety of CART cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events [ Time Frame: 3 months ]

Central Contacts

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