Condition: Non Hodgkin's Lymphoma · Sponsor: Chinese PLA General Hospital
ATHENA chimeric antigen receptor (CAR)-T, a CD19-directed CAR-T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL). The cells are from healthy adult volunteer donors that are knocked out of TRAC and Power3 (SPPL3) genes ex vivo using CRISPR-Cas9 gene editing components. In this study, a second-generation anti-CD19 CAR prototype was constructed, bearing murine FMC63 single-chain variant fragment (scFv) together with intracellular CD28 co-stimulatory and CD3ζ signaling domains linked by a CD28 sequence comprising the hinge and transmembrane domains. This is a single center, prospective, open-label, single-arm, phase 1/2 study. A total of around 30 patients with r/r B-cell NHL will be enrolled in the study and receive allogeneic CD19-CAR-T cell infusion. Phase 1 (n=6 to 18) is a dose escalation part, and phase 2 (n=10 to 12) is a expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of ATHENA CAR-T 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, Ph.D · +86-010-66937463 · liuyang301blood@163.com
Always discuss trial participation with your own doctor first.
| Biotherapeutic Department, Chinese PLA General Hospital | Beijing, China | Recruiting |
| EdiGene Inc | Beijing, China | Recruiting |
| School of Life Sciences, Peking University | Beijing, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06014073