Clinical Study of Universal CD19 CAR-γδT Cell Injection in the Treatment of Adult Relapsed/Refractory B-cell Lymphoma

January 19, 2026 updated by: Meiling Li, The Second Affiliated Hospital of Fujian Medical University
This study is an open-label, single-arm clinical trial designed to evaluate the safety and tolerability of QH103 cell injection solution in adult subjects with relapsed/refractory CD19-positive B-cell lymphoma.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Quanzhou, Fujian, China, 362000
        • The Second Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years, no gender restrictions;

  • Clinically diagnosed with relapsed/refractory B-cell lymphoma, malignant B- cell lymphoma (according to the Lugano (2014) criteria, with at least one evaluable tumour lesion, defined as: Lymph node lesions with a longest diameter exceeding 1.5 cm, or extranodal lesions with a longest diameter exceeding 1.0 cm), including diffuse large B-cell lymphoma (DLBCL-NOS), encompassing activated B-cell (ABC)/grossly centre B-cell (GCB) subtypes, primary mediastinal (thymic) large B-cell lymphoma (PMBCL), transformative follicular lymphoma (TFL), high-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6 rearrangements,follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL)

    1. Relapsed B-cell lymphoma is defined as disease progression following ≥2 systemic therapies;
    2. Refractory disease is defined as failure to achieve complete remission (CR) on first-line therapy, or best response to first-line therapy being disease progression (PD), or best response after at least 4 cycles of first-line therapy being stable disease (SD)(e.g., 4 cycles of R-CHOP), or best response after at least 6 cycles being partial remission (PR) with biopsy-confirmed residual disease or disease progression within ≤6 months of treatment.
  • Cytologically or histologically confirmed CD19-positive tumour cell immunophenotyping;
  • Expected survival exceeding 3 months;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • Major organ function meeting the following criteria: Echocardiogram showing left ventricular ejection fraction ≥50%; serum creatinine ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3 × ULN; total bilirubin ≤ 1.5 × ULN;
  • Negative pregnancy test for women of childbearing potential; both male and female subjects must agree to use effective contraception during treatment and for 1 year thereafter;
  • Toxicity from prior antineoplastic therapy ≤ Grade 1 (per CTCAE version 5.0) or acceptable to the inclusion/exclusion criteria;
  • No significant hereditary disorders;
  • Ability to comprehend trial requirements and procedures, with willingness to participate in the clinical study as directed;
  • Signing of the trial informed consent form.

Exclusion Criteria：

  • Presence of central nervous system (CNS) involvement or clinically significant history of CNS disorders, such as epilepsy and cerebrovascular disease;
  • Pregnant or lactating women, or women unwilling to use effective contraception during treatment and for 1 year post-treatment;
  • Unremitted other malignancies;
  • Patients with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;
  • Patients who received allogeneic immune cell therapy within 6 months prior to enrolment, or donor lymphocyte infusion within 6 weeks prior to enrolment;
  • Confirmed serum reactivity positive for anti-FMC63 and DSA;
  • Patients participating in other clinical trials within 4 weeks prior to enrolment;
  • 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 pectoris, arrhythmias, or conditions deemed to pose unpredictable risks by the treating physician;
  • History of stroke or intracranial haemorrhage within 3 months prior to enrolment;
  • Major surgery or trauma within 28 days prior to enrolment, or unresolved significant adverse events;
  • History of allergy to any component of the cell product;
  • Inability to comprehend or unwillingness to sign the informed consent form;
  • Other reasons deemed by the investigator to render the patient unsuitable for the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult patients with relapsed/refractory CD19-positive B-cell lymphoma

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
Biological: QH103 Cell Injection
Biological: CD 19-CAR T cell Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with dose escalation (3+3) : dose 1 (3×10^8 CAR+cells) ,dose 2 (6× 10^8 CAR+cells).
Other Names:
  • CD19CAR-γδT cell injection
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD)
Time Frame: 28 days
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
28 days
Adverse Event
Time Frame: 12months
AE is defined as any adverse medical event from the date of leukapheresis to 12 months after QH103 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
12months
Incidence of Dose-Limiting Toxicities (DLTs)
Time Frame: First infusion date of QH103 cells to 28 days end cell infusion
DLT was defined as QH103 Cells-related events with onset within first 28 days following infusion.
First infusion date of QH103 cells to 28 days end cell infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK-Tmax
Time Frame: 12 months
Time to peak in CAR-T cell count in peripheral blood after infusion of QH103.
12 months
Pharmacodynamics: Peak level of cytokines in serum
Time Frame: 12 months
The Changes from baseline of level cytokines and chemokines in peripheral blood after infusion of QH103
12 months
Overall Response Rate(ORR)
Time Frame: 6 months
Defined as complete response plus partial response.
6 months
Overall Survival（OS）
Time Frame: 6 months&12 months
Survival as estimated by Kaplan-Meier method. Death from any cause is considered as event for analysis.
6 months&12 months
Progression-Free Survival（PFS）
Time Frame: 6 months
Survival as estimated by Kaplan-Meier method. The length of time during and after the treatment of a disease is considered as event for analysis.
6 months
PK-Cmax
Time Frame: 12 months
Peak concentration (Cmax) in the CAR-T cell count in peripheral blood after infusion of QH103.
12 months
PK-AUC
Time Frame: 12 months
Area under the concentration-time curve of CAR-T cell count in peripheral blood after infusion of QH103 from 0 to 12 months
12 months
PK-Tlast
Time Frame: 12 months
The final time point in CAR-T cell count in peripheral blood after infusion of QH103.
12 months
PK-Clast
Time Frame: 12 months
The final point concentration (C last) in the CAR-T cell count in peripheral blood after infusion of QH103
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

January 5, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QH10309-NHB-01（0）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If used for publication in academic papers, data that does not involve the personal privacy of research subjects will be provided in accordance with journal requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent/Refractory B-cell Lymphoma

Clinical Trials on QH103 Cell Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe