Condition: Non Hodgkin's Lymphoma · Sponsor: Chinese PLA General Hospital
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.
This description comes directly from the study's public registry record.
Weidong Han, Ph.D · +86-010-55499341 · hanwdrsw@sina.com
Yang liu, M.D · +86-010-66937463 · liuyang301blood@163.com
Always discuss trial participation with your own doctor first.
| School of phamaceutical, Tsinghua University | Beijing, Beijing Municipality, China | Recruiting |
| Biotherapeutic Department, Chinese PLA General Hospital | Beijing, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05554939