Actively Recruiting
Clinical Study of the Safety and Efficacy of QH101 Cell in Patients With Malignant Tumors.
Led by Chinese PLA General Hospital · Updated on 2026-05-06
24
Participants Needed
1
Research Sites
293 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
QH101 is an allogeneic TCR-enhanced Vδ2 T cell therapeutic product. By introducing a specific BTN protein-binding moiety onto the cell surface, it leverages the inherent tumoricidal capacity of Vδ2 T cells and enhances their recognition of BTN proteins, thereby improving the killing efficiency against tumor cells. Meanwhile, QH101 does not express co-stimulatory signaling domains or the CD3ζ domain, which avoids cell exhaustion caused by excessive activation and effectively improves the persistence of cells in vivo. This study is an open, prospective, open-label, phase I/II clinical trial designed to evaluate the safety and efficacy of QH101 Cell Injection in subjects with relapsed/refractory hematologic malignancies and advanced solid tumors.
CONDITIONS
Official Title
Clinical Study of the Safety and Efficacy of QH101 Cell in Patients With Malignant Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years (inclusive)
- Expected survival time of at least 3 months
- Confirmed diagnosis of malignant hematologic tumor or solid tumor that has failed standard therapy
- For solid tumors, at least one evaluable lesion according to RECIST v1.1
- Adequate bone marrow function: WBC ≥ 3×10⁹/L, lymphocytes ≥ 0.8×10⁹/L, hemoglobin ≥ 80 g/L, platelets ≥ 75×10⁹/L
- Liver function within limits: ALT and AST ≤ 3× upper limit of normal, total bilirubin ≤ 3× upper limit of normal
- Kidney function within limits: serum creatinine ≤ 1.5× upper limit of normal
- Heart function with LVEF ≥ 50% by echocardiogram
- Normal oxygen saturation without supplemental oxygen
- ECOG performance status 0 or 1
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during treatment and for 1 year after
- Ability to understand and willing to participate in the clinical trial
- Voluntary signing of informed consent
You will not qualify if you...
- Allergy, hypersensitivity, intolerance, or contraindication to QH101 or any study drug components
- Continuous use of immunosuppressants within 1 month before QH101 infusion
- History of stroke or seizure within 6 months before consent
- Symptomatic brain metastases
- Psychiatric or substance abuse disorders affecting compliance
- Positive for hepatitis B or C with active infection, HIV, or syphilis
- Severe cardiac disease including unstable angina, recent myocardial infarction, congestive heart failure (NYHA Class III or higher), or severe arrhythmia
- Active or uncontrolled infection needing systemic therapy (except mild urogenital or upper respiratory infections)
- Unrecovered acute toxic effects from prior therapy (grade 2 or higher hematological or organ toxicity)
- Diagnosed immunodeficiency
- Active infection requiring systemic treatment
- Planning pregnancy within 2 years after cell infusion (female of childbearing potential) or partner planning pregnancy (male)
- Participation in another investigational drug study within 1 month before screening
- Last anti-tumor therapy given less than 5 drug half-lives before planned QH101 infusion
- Any other condition making participation unsuitable as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
W
Weidong Han
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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