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

NCT07570563 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-06

No results posted yet for this study

Summary

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

Interventions

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).

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2029-06-30
Completion
2031-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570563 on ClinicalTrials.gov