Clinical Study of the Safety and Efficacy of Allogeneic TCR-enhanced Vδ2 T Cell in Patients With Malignant Tumors.

Sponsor
Chinese PLA General Hospital
Study ID
NCT07570563
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Hematologic Malignancy
  • Solid Tumor

Eligibility Criteria

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

Interventions

  • Allogeneic TCR-enhanced Vδ2 T cell Injection — BIOLOGICAL
    Allogeneic TCR-enhanced Vδ2 T cells in a standard 3+3 dose-escalation design. Three predefined dose levels are investigated: Dose 1: 1×10\^7 enTCR Vδ2T cells/kg, Dose 2: 3×10\^7 enTCR Vδ2T cells/kg, and Dose 3: 6×10\^7 enTCR Vδ2T cells/kg.
  • Cyclophosphamide injection — DRUG
    For patients with hematological tumors, cyclophosphamide should be administered from day 5 to day 3 before cell infusion, with a recommended dose of 500 - 1000 mg/m² per day. For patients with solid tumors, cyclophosphamide should be administered from day 4 to day 3 before cell infusion, with a recommended dose of 500 - 700 mg/m² per day.
  • Fludarabine Injection — DRUG
    For patients with hematological tumors, fludarabine should be administered from day 5 to day 3 before cell infusion, and the recommended dose is 30 - 50 mg/m² per day. For patients with solid tumors, fludarabine should be administered from day 4 to day 3 before cell infusion, with a recommended dose of 30 - 40 mg/m² per day.
  • Albumin paclitaxel injection — DRUG
    This is only applicable to patients with solid tumors. It should be administered on the fifth day before cell infusion. The recommended dosage is 150-200 mg/m² per day.

Study Details

The allogeneic TCR-enhanced Vδ2 T cell product is a novel genetically engineered cellular therapeutic. By engineering a specific BTN protein-binding moiety on its cell surface, this product harnesses the intrinsic tumoricidal potential of endogenous Vδ2 T cells and augments BTN protein recognition capability, thereby significantly boosting tumor cell killing potency. Notably, this engineered cell product exhibits no expression of co-stimulatory signaling domains and CD3ζ domains. This design circumvents T cell exhaustion triggered by overactivation and markedly enhances the in vivo persistence of therapeutic cells. This is an open, prospective, open-label Phase I/II clinical trial designed to assess the safety and therapeutic efficacy of allogeneic TCR-enhanced Vδ2 T cell injection in patients with relapsed or refractory hematologic malignancies and advanced solid tumors.

Key Dates

First listed
May 6, 2026
Start date
Jun 5, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2031

Study Design

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

Arms

  • Experimental: Patients with Relapsed/refractory hematologic malignancies and advanced solid tumor
    A conditional chemotherapy regimen of fludarabine and cyclophosphamide(for patients with solid tumors, albumin paclitaxel will be used additionally) will be administered, followed by investigational therapy, allogeneic TCR-enhanced Vδ2 T cell.

Primary Outcome Measure

Adverse Event [ Time Frame: 12 months ]

Central Contacts

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