Abstract
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)
Clinical lymphoma, myeloma and leukemia, Vol.25(Suppl 1), pp.S1068-S1069
09/2025
DOI: 10.1016/S2152-2650(25)02881-2
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.
Details
- Title: Subtitle
- 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)
- Creators
- Krish Patel - Sarah Cannon Research InstituteJoanna Rhodes - Rutgers Cancer Institute, Piscataway, NJ, USALuke Mountjoy - Colorado Blood Cancer InstituteJacob Haaber Christensen - Odense University HospitalMartin Hutchings - University of CopenhagenPaul Shaughnessy - Texas Transplant Institute, San Antonio, TX, USANosha Farhadfar - Texas Transplant Institute, San Antonio, TX, USAConstantine Tam - Monash UniversityJohn Baird - City Of Hope National Medical CenterAravind Ramakrishnan - St. David's South Austin Medical Center, Austin, TX, USAMargot Jak - University Medical Center UtrechtKathleen Anne Dorritie - University of Pittsburgh Medical CenterAllison Barraclough - Fiona Stanley HospitalDaniel Morillo - Hospital Universitario Fundación Jiménez DíazYasmina Serroukh - Erasmus Medical Center, Rotterdam, NetherlandsMatthew Schwede - Swedish Cancer InstituteAhmed Abdulgawad - The Christie NHS Foundation TrustLaura Magnano Mayer - Hospital Clínico de Barcelona, Barcelona, SpainMaeve O’Reilly - University College London Hospitals, London, United KingdomJohn Kuruvilla - Princess Margaret Cancer CentreYoungil Koh - Seoul National University HospitalUmar Farooq - University of IowaWon Seog Kim - Samsung Medical CenterJacqueline Bussolari - Johnson & Johnson, Spring House, USAMelissa Beelen - Johnson & Johnson, Spring House, USAJulie Larsen - Johnson & Johnson, Los Angeles, CA, USAMahipal Suraneni - Johnson & Johnson, San Diego, CA, USAJianmei Wu - Johnson & Johnson, Spring House, USALeen Slaets - Johnson & Johnson, Spring House, BelgiumAlfredo Perales-Puchalt - Johnson & Johnson, Spring House, SpainArnob Banerjee - Johnson & Johnson, Spring House, USAMatthew Ku - University of Melbourne
- Resource Type
- Abstract
- Publication Details
- Clinical lymphoma, myeloma and leukemia, Vol.25(Suppl 1), pp.S1068-S1069
- DOI
- 10.1016/S2152-2650(25)02881-2
- ISSN
- 2152-2650
- Publisher
- Elsevier Inc
- Language
- English
- Date published
- 09/2025
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984949519302771
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