Safety and efficacy of allogeneic CD19-directed CAR-T therapy CTX110 in relapsed/refractory B-cell non-Hodgkin lymphoma
- Author(s)
- McGuirk, JP; Ghobadi, A; Bachier, CR; Shaughnessy, PJ; Awan, FT; Maakaron, JE; Bishop, MR; Ho, PJ; Tam, CS; Dickinson, MJ; Darrah, JM; Waller, EK; Murthy, HS; Ross, A; Williams, LM; Pan, C; Stevens, WN; Serwer, L; Nguyen, T; Terrett, J; Kalaitzidis, D; Ma, A; Xu, H; Benton, MD; Weaver, A; Cohen, SB; Maziarz, RT; Cheah, CY;
- Journal Title
- Blood Advances
- Publication Type
- Online publication before print
- Abstract
- This multicenter, single-arm, phase 1/2 study evaluated the safety and efficacy of CD19-directed allogeneic chimeric-antigen-receptor (CAR) immunotherapy CTX110 in adult patients with relapsed/refractory (r/r) B-cell non-Hodgkin lymphoma (NHL). Patients received 1 or 2 treatment courses: standard lymphodepletion, followed by 1 CTX110 infusion at dose levels (DLs) 1-4 (3-60 × 107 CAR T-cells; dose escalation, N=32), or 2 infusions at DL4 on days 1 and 35 (cohort expansion, N=31). Primary endpoints in dose escalation and cohort expansion were incidence of dose-limiting toxicities and objective response rate, respectively. CTX110 was administered to 63 heavily pretreated patients: 59% primary refractory, 43% with ≥3 prior treatment lines. Among 57 patients whose first infusion was DL≥3, rates of objective and complete response (CR) were 65% and 39%, respectively. Among 22 patients achieving CR, 5 (23%) had ongoing CR at data cutoff, with 15-50 (median 34) months follow-up. The 2-infusion regimen appeared to prolong response duration compared to 1 infusion (hazard ratio 0.65). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were reported in 54% and 13% of treated patients, respectively, including 2 grade ≥3 cases each. The most common grade ≥3 adverse events were neutropenia (59%), and anemia and thrombocytopenia (35% each). Serious adverse events occurred in 32% of treated patients, including CRS (14%), ICANS (8%), and febrile neutropenia (6%). In this r/r NHL population, CTX110 was well-tolerated, resulting in clinically meaningful responses at DL≥3, with a second infusion demonstrating evidence of further clinical benefit. This trial (NCT04035434) was registered at www.clinicaltrials.gov.
- Department(s)
- Haematology
- Publisher's Version
- https://doi.org/10.1182/bloodadvances.2026020123
- Open Access at Publisher's Site
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Creation Date: 2026-05-19 06:10:13
Last Modified: 2026-05-19 06:10:46