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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Weidong Han
• Email: hanwdrsw@163.com
• Phone: +86-010-55499341

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.