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ABCL-869: Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product, Exhibits a Manageable Safety Profile With Low Rates of Grade ≥3 CRS and ICANS in Relapsed/Refractory Large B-Cell Lymphoma
Abstract   Peer reviewed

ABCL-869: Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product, Exhibits a Manageable Safety Profile With Low Rates of Grade ≥3 CRS and ICANS in Relapsed/Refractory Large B-Cell Lymphoma

Sarah Larson, Tahir Latif, Umar Farooq, Locke Bryan, Stefan Ciurea, Nebu Koshy, Boyu Hu, Bradley Hunter, Felix Mensah, Mehdi Hamandani, …
Clinical lymphoma, myeloma and leukemia, Vol.26, pp.S926-S927
08/2026
DOI: 10.1016/S2152-2650(26)02599-1

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Abstract

Background: Emerging dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidates represent a next-generation approach to improve outcomes for patients with large Bcell lymphoma (LBCL). Early efficacy data are promising, but comprehensive safety data are needed to establish their clinical potential. We report updated safety data for rondecabtagene autoleucel (ronde-cel), an autologous, dual-targeting CD19/CD20 CAR T-cell product candidate manufactured from CD62L-enriched T cells. Methods: Patients with relapsed/refractory (R/R) LBCL (N = 87) were enrolled in a phase 1/2 trial (NCT05826535) evaluating ronde-cel following lymphodepletion with fludarabine and cyclophosphamide. Eligible patients received ≥1 prior line of therapy (2L or 3L+). Safety assessments included cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS), infections, and laboratory evaluations. Low-dose dexamethasone (10 mg/day on days 0, 1, and 2) was introduced for ICANS prophylaxis and is now required for all patients. Results: As of January 9, 2026, 84 patients had received ronde-cel (2L, n = 35; 3L+, n = 49) at the phase 2 dose of 100×106 CAR T cells. Median age was 64 years (range, 20–87 years), 67% had primary refractory disease, and median follow-up was 8 months (range, 0.2–26 months). CRS occurred in 60% of patients (50 of 84): grade 1 in 36% and grade 2 in 24%, with no grade ≥3 CRS events. Median time to CRS onset was 5 days (range, 1–18 days), and resolution time was 3 days (range, 1–21 days). Tocilizumab was administered in 35% of patients. ICANS was predominantly low-grade, with grade 1 or 2 events in 11% of patients (9 of 84) and grade ≥3 in 3% of patients (1 of 37) who received dexamethasone prophylaxis versus 13% (6 of 47) who did not. Grade ≥3 infections occurred in 10% of patients (8 of 84). Prolonged cytopenias (grade ≥3 not resolved by day 28) were observed in 23% of patients (19 of 84). No deaths attributable to ronde-cel were reported. Conclusions: Ronde-cel demonstrated a consistent and manageable safety profile in a broad population with R/R LBCL. The absence of grade ≥3 CRS and low rates of grade ≥3 ICANS and infection support the feasibility of ronde-cel administration in the outpatient setting. 2L: second-line, 3L+: third-line or higher, CD: cluster of differentiation.
 ABCL aggressive B-cell lymphoma B-cell lymphoma CAR T-cell product dual targeting large B-cell lymphoma phase 2

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