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

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

NCT07367685•The Second Affiliated Hospital of Fujian Medical University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;

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.
•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;
+6 more criteria

Locations (1)

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Key Dates

Start Date

May 1, 2026

Primary Completion Date

April 30, 2028

Completion Date

December 31, 2028

Last Updated

January 26, 2026

Enrollment

ESTIMATED participants

Conditions

Recurrent/Refractory B-cell Lymphoma

Interventions

QH103 Cell Injection

BIOLOGICAL

Cyclophosphamide

DRUG

Fludarabine

DRUG

Contacts

Jianda Hu

CONTACT

+86 13959169016 drjianda_hu@163.com