Clinical Study of Universal CD19 CAR-γδT Cell Injection in the Treatment of Adult Relapsed/Refractory B-cell Lymphoma
1 other identifier
interventional
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2026
CompletedFirst Posted
Study publicly available on registry
January 26, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 26, 2026
January 1, 2026
2 years
January 5, 2026
January 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adverse Event
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)
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
Maximum tolerated dose (MTD)
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
28 days
Secondary Outcomes (9)
PK-Tmax
12 months
Pharmacodynamics: Peak level of cytokines in serum
12 months
Overall Response Rate(ORR)
6 months
Overall Survival（OS）
6 months&12 months
Progression-Free Survival（PFS）
6 months
- +4 more secondary outcomes
Study Arms (1)
Adult patients with relapsed/refractory CD19-positive B-cell lymphoma
EXPERIMENTALA 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
Interventions
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).
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).
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).
Eligibility Criteria
You may qualify if:
- 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)
- Relapsed B-cell lymphoma is defined as disease progression following ≥2 systemic therapies;
- 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;
You may not qualify if:
- 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.
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
- The Chief of the Department of Hematology
Study Record Dates
First Submitted
January 5, 2026
First Posted
January 26, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
January 26, 2026
Record last verified: 2026-01