NCT05554939 Allogenic CD19-targeting CAR-γδT Cell Therapy in R/R NHL
| NCT ID | NCT05554939 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Non Hodgkin's Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-12-11 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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Brief Summary
This is a single center, prospective, open-label, single-arm, phase 1/2 study for patients with r/r B-cell NHL to evaluate the safety and efficacy of gene edited allogenic CD19 CAR-γδT cells. The cells are from healthy adult volunteer donors that are gene edited ex vivo using CRISPR-Cas9 to weaken HLA expression and further to overcome host immune system rejection (HvGR). In this study, a second generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular 4-1BB co-stimulatory and CD3ζ signaling domains linked by a CD8α sequence comprising the hinge and transmembrane domains. A total of around 30 patients with r/r B-cell NHL will be enrolled in the study and receive allogeneic CD19 CAR-γδT cell infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of allogeneic CD19 CAR-γδT cell therapy in patients with r/r B-cell NHL.
Eligibility Criteria
Inclusion Criteria for patients: 1. Age 18-75 (inclusive). 2. Patients with histologically confirmed CD19-positive B-cell NHL, including the following types defined by the World Health Organization (WHO) 2016: * Diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), including Activated B-cell type (ABC）/Germinal center B-cell type（GCB）; * Primary mediastinal (thymic) large B-cell lymphoma (PMBCL); * Transformed follicular lymphoma (TFL); * High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (HGBCL); * Follicular lymphoma (FL); * Mantle cell lymphoma (MCL) (pathologically confirmed, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1); * Marginal zone lymphoma (MZL), including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue (MALT) lymphoma. 3. Relapse after treatment with ≥2 lines systemic therapy for all the above disease types, or refractory dis