NCT07570563 Clinical Study of the Safety and Efficacy of Allogeneic TCR-enhanced Vδ2 T Cell in Patients With Malignant Tumors.

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 24 participants in total. It began in 2026-06-05 with a primary completion date of 2029-06-30.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age 18-75 (inclusive). * Expected survival time ≥ 3 months. * Meets current clinical diagnostic criteria with a confirmed diagnosis of a malignant hematologic tumor or solid tumor, and has failed standard therapy (for solid tumors, at least one evaluable lesion according to RECIST v1.1 is required). * Adequate bone marrow reserve and essentially normal liver and kidney function (laboratory tests must meet the following criteria prior to the first allogeneic TCR-enhanced Vδ2 T cell treatment): * Hematology: White Blood Cell Count (WBC) ≥ 2.5×10⁹/L, Lymphocyte Count (LY) ≥ 0.8×10⁹/L, Hemoglobin (Hb) ≥ 80 g/L, Platelets (PLT) ≥ 75×10⁹/L. * Liver: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; Total Bilirubin ≤ 3.0 × ULN. * Kidney: Serum Creatinine ≤ 1.5 × ULN. * Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as measured by echocardiogram. * Pulmonary: Normal oxygen saturation without supplemental oxygen. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1. * A negative pregnancy test is required for women of childbearing potential. Both male and female subjects must agree to use effective contraception during the treatment period and for 1 year thereafter. * Able to understand the trial requirements and is willing to participate in the clinical study as required. * Voluntarily signs the informed consent form for the clinical trial. Exclusion Criteria: * Known history of allergy, hypersensitivity, intolerance, or contraindication to allogeneic TCR-enhanced Vδ2 T cell or any components of the study drugs (including fludarabine, cyclophosphamide and albumin paclitaxel). * Continuous use of immunosuppressants within 1 month prior to allogeneic TCR-enhanced Vδ2 T cell infusion. * History of cerebrovascular accident or seizure within 6 months prior to signing the informed consent. * Symptomatic brain metastases. * Known psychiatric or substance abuse disorders that would compromise compliance with study requirements. * Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) with detectable Hepatitis B virus (HBV) DNA levels outside the normal reference range; positive for Hepatitis C virus (HCV) antibody with detectable HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibody; positive for syphilis. * Severe cardiac disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA Class ≥ III), and severe arrhythmia. * Active or uncontrolled infection requiring systemic therapy (except for mild urogenital and upper respiratory tract infections). * Has not recovered from acute toxic effects of prior therapy (i.e., persisting hematological or organ toxicity ≥ Grade 2 related to prior therapy, excluding abnormalities associated with the study disease and its history). * Diagnosed with immunodeficiency. * Active infection requiring systemic treatment. * Female subjects of childbearing potential planning pregnancy within 2 years after cell infusion; or male subjects whose partners are planning pregnancy within 2 years after cell infusion. * Participation in another investigational drug clinical study within 1 month prior to screening. * Last anti-tumor therapy administered less than 5 half-lives of the drug prior to planned allogeneic TCR-enhanced Vδ2 T cell infusion. * Any other condition deemed by the investigator to make the subject unsuitable for participation in this study.

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