🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07570563
Recruiting Phase 1/2

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

NCT07570563 · tracked via the Priya Life Science China tracker
Sponsor
Chinese PLA General Hospital
Phase
Phase 1/2
Started
2026-06-05
Last updated
2026-06-08

Condition(s) studied

Hematologic MalignancySolid Tumor

Investigational drug(s) / intervention(s)

Allogeneic TCR-enhanced Vδ2 T cell InjectionCyclophosphamide injectionFludarabine InjectionAlbumin paclitaxel injection

Allogeneic TCR-enhanced Vδ2 T cell Injection: 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: 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: 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: 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 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Biotherapeutic Department of Chinsese PLA Gereral Hospital Beijing Beijing Municipality Recruiting

More Chinese PLA General Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07570563 on ClinicalTrials.gov ↗ ← All trials in China