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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed/Refractory CD19-positive B-ALL
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: QH103 Cell Injection

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ting Yang; Phone Number: +86 13950210357; Email: yang.hopeting@gmail.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • The First Affiliated Hospital of Fujian Medical University
      • Contact: Ting Yang; Phone Number: +86 13950210357; Email: yang.hopeting@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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:

  1. Failure to achieve CR after 2 cycles of standard chemotherapy;
  2. Initial induction achieved CR, but CR duration ≤12 months;
  3. Relapsed/refractory B-ALL refractory to first or multiple salvage therapies;
  4. Post-hematopoietic stem cell transplantation relapse, including hematological relapse and minimal residual disease (MRD) positivity;
  5. 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;
• Toxicity from prior anti-tumor therapy ≤ Grade 1 (according to CTCAE v5.0) or at an acceptable level per inclusion/exclusion criteria;
• 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

Exclusion Criteria:

• 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;
• Other reasons deemed by the researchers as unsuitable for the clinical trial.

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 CD19-positive acute B-lymphoblastic leukemia; 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; 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).; Other Names: CD19CAR-γδT cell injection; Drug: Fludarabine; 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).; Biological: QH103 Cell Injection; 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).; Other Names: CD19CAR-γδT cell injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cell therapy; CD19; CAR-γδT
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence; Organic Chemicals; Hydrocarbons; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclophosphamide; fludarabine
• Other Study ID Numbers: QH10309-NHB-01（0）

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