Clinical Study of Universal CD19 CAR-γδ T Cell Infusion in the Treatment of Relapsed/Refractory Acute B Lymphoblastic Leukemia

NCT07491263 | Not Yet Recruiting Phase 1

• 1 other identifier: QH10309-NHB-01（0）
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell infusion in subjects with CD19-positive R/R B-ALL.

Conditions

Relapsed/Refractory CD19-positive B-ALL

Keywords

CD19; CAR-γδT; cell therapy

Outcome Measures

Primary Outcomes (2)

• Adverse Event

  12 months

• Incidence of Dose-Limiting Toxicities (DLTs)

  DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.

  28 days

Secondary Outcomes (3)

• PK(Pharmacokinetics):Number and Copy Number of CD19 CAR-γδT cells

  12 months

• PK: Persistence of CD19 CAR-γδT

  12 months

• PD(Pharmacodynamics) ：Changes in Various Cytokine Levels (IL-2, IL-4, IL-6, IFN-γ, TNF α, etc.) from Baseline

  12 months

Study Arms (1)

Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia

EXPERIMENTAL

A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells Interventions: Biological: QH103 Cell Injection Drug: Fludarabine Drug: Cyclophosphamide

Drug: Cyclophosphamide; Drug: Fludarabine; Biological: QH103 Cell Injection

Interventions

Cyclophosphamide DRUG

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).

Also known as: CD19CAR-γδT cell injection

Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia

Fludarabine DRUG

Eligible subjects will receive lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30-40 mg/m² administered 3 days).

Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia

QH103 Cell Injection BIOLOGICAL

Biological: CD19 CAR-γδT cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (1×10\^8 CAR+cells) ,dose 2 (3× 10\^8 CAR+cells).

Also known as: CD19CAR-γδT cell injection

Patients with relapsed/refractory CD19-positive acute B-lymphoblastic leukemia

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 14 years, gender unrestricted;
• Clinically diagnosed with relapsed/refractory acute B-lymphoblastic leukemia, with bone marrow blast/immature lymphocyte proportion ≥5% (morphology) (excluding cases with isolated extramedullary involvement), meeting any of the following criteria:
• Failure to achieve CR after 2 cycles of standard chemotherapy;
• Initial induction achieved CR, but CR duration ≤12 months;
• Relapsed/refractory B-ALL refractory to first or multiple salvage therapies;
• Post-hematopoietic stem cell transplantation relapse, including hematological relapse and minimal residual disease (MRD) positivity;
• Patients for whom no standard therapy exists.
• Cytology or histology confirms tumor cell immunophenotype as CD19-positive;
• Expected survival time exceeding 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
• Key organ functions meeting the following criteria: left ventricular ejection fraction ≥50% by echocardiography; serum creatinine ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN; total bilirubin ≤1.5 × ULN;
• Negative pregnancy test for women of childbearing potential; both males and females agree to use effective contraception during treatment and for 1 year thereafter;

You may not qualify if:

• No significant hereditary diseases;
• Able to comprehend the trial requirements and procedures, and willing to participate in the clinical study as required;
• Signed informed consent form for the trial
• Presence of central nervous system (CNS) involvement or a clinically significant history of CNS diseases, such as epilepsy and cerebrovascular diseases;
• Pregnant or lactating women, or women who disagree to use effective contraception during treatment and within 1 year after treatment;
• Other malignancies that are not in remission;
• Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
• Patients who have received allogeneic immune cell therapy within 6 months before enrollment, or donor lymphocyte infusion within 6 weeks before enrollment;
• Confirmed positive anti-FMC63 and DSA responses in the patient's serum;
• Patients who have participated in other clinical trials within 4 weeks before enrollment;
• Uncontrolled infectious diseases or other serious conditions, including but not limited to infections (human immunodeficiency virus, acute or chronic active hepatitis B or C), congestive heart failure, unstable angina, arrhythmia, or conditions considered by the treating physician to pose unpredictable risks;
• History of stroke or intracranial hemorrhage within 3 months before enrollment;
• Major surgery or trauma within 28 days before enrollment, or main side effects not yet recovered;
• History of allergy to any component of the cell product;
• Inability to understand or unwillingness to sign the informed consent form;

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

The first affiliated hospital of fujian medical university

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Recurrence

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Ting Yang

CONTACT

+86 13950210357; yang.hopeting@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Second Hematology Department and Hematopoietic Stem Cell Transplantation Center

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)