Clinical Study of the Safety and Efficacy of QH101 Cell in Patients With Malignant Tumors.

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Hematologic Malignancy
• Intervention / Treatment: Biological: QH101 Cell Injection; Drug: Cyclophosphamide injection; Drug: Fludarabine Injection

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Weidong Han; Phone Number: +86-010-55499341; Email: hanwdrsw@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100853
      • Recruiting
      • Biotherapeutic Department of Chinsese PLA Gereral Hospital
      • Contact: Yang Liu, M.D; Phone Number: +86 010-66939460; Email: liuyang301blood@163.com
      • Contact: Weidong Han, PH.D; Phone Number: +86 +86-010-66937463; Email: hanwdrsw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with Relapsed/refractory hematologic malignancies and relapsed/refractory solid tumor; A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH101 cell Interventions. Biological: QH101 cell Injection Drug: Fludarabine and Cyclophosphamide

Biological: QH101 Cell Injection; Biological: QH101 cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10^7 CAR+cells) ,dose 2 (3× 10^7 CAR+cells)，dose 3 (6× 10^7 CAR+cells). After the MTD and/or RP2D is determined in the dose escalation phase, a cohort expansion study may be initiated upon the investigator's decision. Enrolled subjects will receive QH101 infusion following lymphodepleting conditioning at the MTD and/or RP2D dose level established during the dose escalation phase.; Drug: Cyclophosphamide injection; Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (500-1000 mg/m² administered 3 days).; Drug: Fludarabine Injection; Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-50 mg/m² administered 3 days).; Other Names: Fludarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	AE is defined as any adverse medical event from the date of leukapheresis to 12 months after QH101 cell 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 QH101-related events with onset within first 28 days following infusion	28 days after cell infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK(Pharmacokinetics):Number and Copy Number of QH101 cells	Number and copy number of QH101 cells were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (until QH101 cells were not detected for two consecutive times) to detect the number and copy number of QH101 cells, and to evaluate the pharmacokinetics of QH101.	12 months
PD(Pharmacodynamics):changes over time	To monitor changes over time in the cytokines mainly include interleukin-2 (IL-2 ), IL-4,IL-6, interferon-γ（IFN-γ), Tumor Necrosis Factor-alpha (TNF-α).	12 months
Objective Response Rate	The incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) are the response to treatment assessed by investigators.	12 months after cell infusion
Overall Survival(OS)	OS is defined as the time from QH101 infusion to the date of death.	12 months
Progression Free Survival (PFS)	PFS is defined as the time from the QH101 infusion date to the date of disease progression assessed by investigators.	12 months

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Organic Chemicals; Hydrocarbons; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclophosphamide; fludarabine
• Other Study ID Numbers: CHN-PLAGH-BT-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No