QH101 Vδ2 T-cell therapy for adults with relapsed or advanced malignant tumors

A Clinical Study on the Safety and Efficacy of QH101 Cell Injection in the Treatment of Patients With Malignant Tumors

This study will try QH101, an off-the-shelf Vδ2 T-cell therapy, in adults with relapsed or advanced blood cancers or solid tumors to see if it is safe and helps fight tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Drugs / interventions: cyclophosphamide, fludarabine
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07570563 on ClinicalTrials.gov

What this trial studies

This is an open-label, phase I/II trial of QH101, an allogeneic TCR-enhanced Vδ2 T-cell product engineered with a BTN protein–binding moiety to improve tumor recognition while omitting co-stimulatory and CD3ζ domains to reduce exhaustion and increase in vivo persistence. Eligible adults with relapsed/refractory hematologic malignancies or advanced solid tumors receive lymphodepleting chemotherapy (cyclophosphamide and fludarabine) followed by QH101 cell infusions. The trial primarily monitors safety and tolerability and secondarily looks for signs of anti-tumor activity and persistence of the infused cells. Treatment and follow-up occur at the sponsoring center with serial laboratory, imaging, and clinical assessments.

Who should consider this trial

Good fit: Adults 18–75 with confirmed relapsed or refractory hematologic malignancy or advanced solid tumor who have failed standard therapies, have ECOG 0–1, measurable disease (for solid tumors), and adequate organ and marrow function are the intended participants.

Not a fit: Patients with poor organ or bone marrow function, ECOG performance >1, active need for supplemental oxygen, pregnancy, or very limited life expectancy are unlikely to be eligible or to benefit from this treatment.

Why it matters

Potential benefit: If successful, QH101 could offer an off-the-shelf cellular therapy that kills tumor cells more effectively and persists longer in the body than unmodified cells.

How similar studies have performed: Early clinical and preclinical work with γδ/Vδ2 T-cell and BTN-targeting approaches has shown encouraging signals but remains investigational without definitive, large-scale proof of benefit.

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 QH101 treatment):
* Hematology: White Blood Cell Count (WBC) ≥ 3×10⁹/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 QH101 or any components of the study drugs (including fludarabine and cyclophosphamide).
* Continuous use of immunosuppressants within 1 month prior to QH101 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 QH101 infusion.
* Any other condition deemed by the investigator to make the subject unsuitable for participation in this study.

Where this trial is running

Beijing, Beijing Municipality

• Biotherapeutic Department of Chinsese PLA Gereral Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Weidong Han

Conditions Hematologic Malignancy; Solid Tumor