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CT-1498: A Global Phase 1B Study of JNJ-90014496, A CD19/CD20 Bispecific Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Patients (Pts) With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)
Abstract   Peer reviewed

CT-1498: A Global Phase 1B Study of JNJ-90014496, A CD19/CD20 Bispecific Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Patients (Pts) With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL)

Krish Patel, Joanna Rhodes, Luke Mountjoy, Jacob Haaber Christensen, Martin Hutchings, Paul Shaughnessy, Nosha Farhadfar, Constantine Tam, John Baird, Aravind Ramakrishnan, …
Clinical lymphoma, myeloma and leukemia, Vol.25(Suppl 1), pp.S1068-S1069
09/2025
DOI: 10.1016/S2152-2650(25)02881-2

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Abstract

In a first-in-human study in China, C-CAR039, an autologous anti-CD19/CD20 bispecific CAR T-cell therapy, demonstrated a complete response rate (CRR) of 86% in R/R LBCL pts; progression-free survival and overall survival were not reached at 30-month median follow-up (mFU). To determine a recommended phase 2 dose (RP2D) and assess safety, efficacy, and pharmacokinetics of JNJ-90014496 (formerly C-CAR039) in R/R LBCL patients in this phase 1b study (NCT05421663). Dose levels: 2.0 million (M) CAR+ T cell/kg (weight-based); 150M and 75M CAR+ T cells (fixed-doses). Primary endpoints: safety; RP2D. Secondary endpoints: objective response rate (ORR); CRR; time to first response (TTFR); pharmacokinetics. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) per ASTCT 2019 criteria. As of February 7, 2025, 48 CAR-T-naïve, heavily pretreated R/R LBCL pts were infused: 2.0M CAR+ T cells/kg (n = 18), 150M (n = 8), 75M (n = 22); 46% had ≥2 prior therapies; 65% had bridging therapy; 6-month mFU across all doses: 38 (79%) pts had CRS (grade [G]1, 52%; G2, 23%; G3, 4%), median time to onset of 3 days (range, 1–6), median duration of 5 days (range, 1–42); 7 (15%) pts had ICANS (G1, 8%; G3, 6%), median time to onset of 3 days (range, 3–12), median duration of 8 days (range 1–89). G3/4 and serious treatment-emergent adverse events (TEAEs) were reported in 40 (83%) and 12 (25%) pts, respectively. No treatment-related deaths occurred. Forty-two evaluable pts across all doses: ORR was 90.5% (95% CI, 77.4–97.3); CRR was 76.2% (95% CI, 60.5–87.9). Median time to first response was 1.0 month (range, 0.8–1.9). At RP2D of 75M CAR+ T cells, there were no G3/4 CRS; 19 (86%) pts had G1/2 CRS (G1, 68%; G2, 18%); no G3/4 ICANS; 1 (5%) pt had G1 ICANS; 17 (77%) pts had G3/4 TEAEs and 5 (23%) pts had serious TEAEs. At RP2D in 20 evaluable pts with 3-month mFU: ORR was 95.0% (95% CI, 75.1–99.9); CRR was 80.0% (95% CI, 56.3–94.3). The safety, efficacy, and pharmacokinetics profile supports selection of 75M CAR+ T cells as the RP2D of JNJ-90014496 in pts with R/R LBCL. ACRRof 80% and no G3/4 ICANS or G3/4 CRS from this first global study are promising.
 cancer immunotherapy CAR-T DLBCL relapsed lymphoma

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