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

NCT07570563 | Recruiting Phase 1 DMC

• 1 other identifier: CHN-PLAGH-BT-100
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy; Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Adverse Event

  AE is defined as any adverse medical event from the date of leukapheresis to 12 months after allogeneic TCR-enhanced Vδ2 T cells infusion. Among them, cytokine release syndrome (CRS), immune cell-associated neurotoxicity syndrome (ICANS) , graft-versushost disease (GVHD) are excluded . Other AEs were graded according to the regulatory agency's Medical Dictionary for Regulatory Activities (MedDRA) and common terminology criteria for adverse events (CTCAE) v5.0

  12 months

• DLTs

  DLT was defined as allogeneic TCR-enhanced Vδ2 T cells-related events with onset within first 28 days following infusion

  28 days after cell infusion

Secondary Outcomes (5)

• PK(Pharmacokinetics):Number and Copy Number of allogeneic TCR-enhanced Vδ2 T cell

  12 months

• PD(Pharmacodynamics):changes over time

  12 months

• Objective Response Rate

  12 months after cell infusion

• Overall Survival(OS)

  12 months

• Progression Free Survival (PFS)

  12 months

Study Arms (1)

Patients with Relapsed/refractory hematologic malignancies and advanced solid tumor

EXPERIMENTAL

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.

Biological: Allogeneic TCR-enhanced Vδ2 T cell Injection; Drug: Cyclophosphamide injection; Drug: Fludarabine Injection; Drug: Albumin paclitaxel injection

Interventions

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.

Patients with Relapsed/refractory hematologic malignancies and advanced solid tumor

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.

Also known as: Fludarabine

Patients with Relapsed/refractory hematologic malignancies and advanced solid tumor

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.

Patients with Relapsed/refractory hematologic malignancies and advanced solid tumor

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.

Patients with Relapsed/refractory hematologic malignancies and advanced solid tumor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Biotherapeutic Department of Chinsese PLA Gereral Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Weidong Han

CONTACT

+86-010-55499341; hanwdrsw@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Division of Biotherapy, Department of Oncology

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)