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Johnson & Johnson's dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma

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Johnson & Johnson announced promising first clinical data from a Phase 1b study of JNJ-90014496, a novel dual-targeting CD19/CD20 CAR T-cell therapy for relapsed/refractory large B-cell lymphoma. The therapy showed impressive efficacy with 80% complete response rate in patients with one prior treatment line and 75% in those with two or more prior treatments. At the recommended Phase 2 dose of 75 million CAR+ T-cells, the therapy demonstrated a favorable safety profile with no Grade 3/4 cytokine release syndrome observed. The study involved 22 patients for efficacy assessment, achieving 100% objective response rate in single prior therapy patients and 92% in multiple prior therapy patients. This development represents a potential advancement over current single-antigen CAR T therapies, which typically achieve only 40% long-term remission rates.
Johnson & Johnson ha annunciato dati clinici preliminari promettenti da uno studio di Fase 1b su JNJ-90014496, una nuova terapia CAR T-cell a doppio bersaglio CD19/CD20 per il linfoma a grandi cellule B recidivante/refrattario. La terapia ha mostrato un'efficacia notevole con un tasso di risposta completa dell'80% nei pazienti con una linea di trattamento precedente e del 75% in quelli con due o più trattamenti precedenti. Alla dose raccomandata per la Fase 2 di 75 milioni di cellule CAR+ T, la terapia ha dimostrato un profilo di sicurezza favorevole senza sindrome da rilascio di citochine di grado 3/4. Lo studio ha coinvolto 22 pazienti per la valutazione dell'efficacia, raggiungendo un tasso di risposta obiettiva del 100% nei pazienti con una sola terapia precedente e del 92% in quelli con più terapie precedenti. Questo sviluppo rappresenta un potenziale progresso rispetto alle attuali terapie CAR T a singolo antigene, che solitamente raggiungono solo il 40% di remissione a lungo termine.
Johnson & Johnson anunció datos clínicos iniciales prometedores de un estudio de Fase 1b sobre JNJ-90014496, una novedosa terapia CAR T de doble objetivo CD19/CD20 para linfoma de células B grandes recidivante/refractario. La terapia mostró una eficacia impresionante con una tasa de respuesta completa del 80% en pacientes con una línea previa de tratamiento y del 75% en aquellos con dos o más tratamientos previos. A la dosis recomendada para la Fase 2 de 75 millones de células CAR+ T, la terapia demostró un perfil de seguridad favorable sin síndrome de liberación de citocinas de grado 3/4. El estudio involucró a 22 pacientes para la evaluación de eficacia, logrando una tasa de respuesta objetiva del 100% en pacientes con una sola terapia previa y del 92% en pacientes con múltiples terapias previas. Este avance representa un posible progreso respecto a las terapias CAR T de un solo antígeno actuales, que generalmente alcanzan solo un 40% de remisión a largo plazo.
존슨앤드존슨은 재발/불응성 대형 B세포 림프종 치료를 위한 새로운 이중 표적 CD19/CD20 CAR T 세포 치료제 JNJ-90014496의 1b상 임상 초기 데이터를 발표했습니다. 이 치료법은 이전 치료가 한 번인 환자에서 80%, 두 번 이상인 환자에서 75%의 완전 반응률을 보여 인상적인 효능을 나타냈습니다. 권장 2상 용량인 7,500만 CAR+ T 세포 투여 시 3/4등급 사이토카인 방출 증후군이 관찰되지 않아 안전성 프로필도 우수했습니다. 이 연구에는 22명의 환자가 참여했으며, 1회 치료 경험 환자에서 100%, 다회 치료 경험 환자에서 92%의 객관적 반응률을 기록했습니다. 이는 기존 단일 항원 CAR T 치료제가 보통 40%의 장기 관해율을 보이는 것에 비해 잠재적인 진전으로 평가됩니다.
Johnson & Johnson a annoncé des données cliniques initiales prometteuses issues d'une étude de phase 1b sur le JNJ-90014496, une nouvelle thérapie CAR T à double ciblage CD19/CD20 pour le lymphome à grandes cellules B en rechute/réfractaire. La thérapie a montré une efficacité impressionnante avec un taux de réponse complète de 80 % chez les patients ayant reçu une ligne de traitement préalable, et de 75 % chez ceux ayant reçu deux traitements ou plus. À la dose recommandée pour la phase 2 de 75 millions de cellules CAR+ T, la thérapie a démontré un profil de sécurité favorable sans syndrome de libération de cytokines de grade 3/4. L'étude a porté sur 22 patients pour l'évaluation de l'efficacité, avec un taux de réponse objective de 100 % chez les patients avec une seule thérapie antérieure et de 92 % chez ceux avec plusieurs thérapies antérieures. Ce développement représente une avancée potentielle par rapport aux thérapies CAR T à antigène unique actuelles, qui n'atteignent généralement qu'un taux de rémission à long terme de 40 %.
Johnson & Johnson hat vielversprechende erste klinische Daten aus einer Phase-1b-Studie zu JNJ-90014496 vorgestellt, einer neuartigen CAR-T-Zelltherapie mit doppeltem Ziel CD19/CD20 für rezidivierende/refraktäre großzellige B-Zell-Lymphome. Die Therapie zeigte eine beeindruckende Wirksamkeit mit einer kompletten Ansprechrate von 80 % bei Patienten mit einer vorherigen Behandlungslinie und 75 % bei Patienten mit zwei oder mehr vorangegangenen Therapien. Bei der empfohlenen Phase-2-Dosis von 75 Millionen CAR+ T-Zellen zeigte die Therapie ein günstiges Sicherheitsprofil ohne Auftreten eines Zytokin-Freisetzungssyndroms Grad 3/4. Die Studie umfasste 22 Patienten zur Wirksamkeitsbewertung und erreichte eine objektive Ansprechrate von 100 % bei Patienten mit nur einer vorherigen Therapie und 92 % bei Patienten mit mehreren vorherigen Therapien. Diese Entwicklung stellt einen potenziellen Fortschritt gegenüber aktuellen CAR-T-Therapien mit Einzelantigen dar, die typischerweise nur 40 % Langzeitremissionsraten erreichen.
Positive
  • High efficacy with 80% complete response rate in single prior therapy patients and 75% in multiple prior therapy patients
  • Strong safety profile with no Grade 3/4 cytokine release syndrome observed
  • 100% objective response rate in patients with one prior line of therapy
  • Novel dual-targeting mechanism potentially addressing common resistance mechanisms
  • Promising alternative to current single-antigen CAR T therapies that only achieve 40% long-term remission
Negative
  • 84% of patients experienced Grade 3/4 treatment-emergent adverse events
  • 72% of patients experienced Grade 3/4 neutropenia (reduction in white blood cells)
  • Limited follow-up period of only 4 months
  • 28% of patients reported serious treatment-emergent adverse events

Insights

J&J's dual-targeting CAR-T shows 75-80% complete response rates in lymphoma with favorable safety profile compared to existing therapies.

This Phase 1b data for Johnson & Johnson's novel dual-targeting CAR-T therapy represents a potentially significant advancement in treating relapsed/refractory large B-cell lymphoma (R/R LBCL). The therapy's innovative mechanism - targeting both CD19 and CD20 antigens simultaneously - addresses a critical limitation of current single-antigen CAR-T therapies, which achieve durable remissions in only about 40% of patients.

The efficacy data is particularly compelling: patients receiving one prior line of therapy showed a 100% objective response rate with 80% complete responses, while those with two+ prior lines achieved a 92% objective response rate with 75% complete responses. These rates substantially exceed historical benchmarks for this patient population.

From a safety perspective, the absence of Grade 3-4 cytokine release syndrome - a life-threatening complication that has hampered broader adoption of CAR-T therapies - is noteworthy. Only two cases of ICANS (immune effector cell-associated neurotoxicity syndrome) were observed, with just one being Grade 3 in a patient with CNS lymphoma, which typically carries higher risk.

The neutropenia rate of 72% is consistent with existing CAR-T products and generally manageable. Overall, this safety profile appears more favorable than first-generation CAR-T therapies while potentially offering superior efficacy, though longer follow-up is needed to assess durability of responses and late toxicities.

If these results are maintained in larger trials with longer follow-up, JNJ-4496 could potentially become a preferred option for LBCL patients who have relapsed after initial therapy, offering higher response rates with an improved safety profile compared to current standards.

Phase 1b study suggests a promising safety profile and highlights the potential of a novel dual-targeting CD19/CD20 CAR T in patients with relapsed or refractory disease

75-80% complete response rate among evaluable patients at the recommended Phase 2 dose 

MILAN, June 13, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous chimeric antigen receptor (CAR) T-cell therapy, being studied in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) who have not been previously treated with CAR T-cell therapy.1 Findings demonstrate the potential of JNJ-4496 in the treatment of patients with R/R LBCL, including R/R diffuse large B-cell lymphoma (DLBCL) – the most common type of aggressive lymphoma, a blood cancer that originates in the lymphatic system.1,2 These data were presented as an oral presentation at the 2025 European Hematology Association (EHA) Congress (Abstract #S239).1

JNJ-4496, formerly known as C-CAR039, is a dual-targeting CAR T designed to bind to both CD19 and CD20 antigens — two cell surface proteins commonly expressed on malignant B-cells. This design, including a 4-1BB costimulatory domain, is intended to enhance binding strength and persistence, also potentially addressing common mechanisms of resistance in relapsed or refractory disease.

In the Phase 1b dose confirmation study (NCT05421663) in patients with R/R LBCL, data at the recommended Phase 2 dose (RP2D) were reported in patients with a median follow-up of 4 months. Results informed a RP2D of JNJ-4496 at 75 million CAR+ T-cells. Among the 22 patients in the RP2D group where efficacy was assessed, those who received one prior line of therapy (n=10) had an objective response rate (ORR) of 100 percent and a complete response rate (CRR) of 80 percent (95 percent confidence interval (CI), 69, 100). In the patients who had received two or more prior lines of therapy (n=12), the ORR was 92 percent and the CRR was 75 percent (95 percent CI, 62, 100).1

"There is a pressing need to continue advancing therapies for patients with relapsed or refractory diffuse large B-cell lymphoma. Only about 40 percent of patients have long-term remissions with currently available single-antigen-targeting CD19 CAR T therapies," said Krish Patel*, M.D., Director of Lymphoma Research, Sarah Cannon Research Institute (SCRI), and principal study investigator. "The data presented today show encouraging clinical activity and promising safety, and represent a step forward in delivering a potential new treatment option to patients living with the most common type of aggressive lymphoma."

Within the RP2D safety group (n=25), 52 percent of patients (n=13) received two or more prior lines of therapy, and 56 percent (n=14) received bridging therapy. In the RP2D cohort studied, no cases of Grade 3 or 4 cytokine release syndrome were observed. Two patients had immune effector cell-associated neurotoxicity syndrome (ICANS), one Grade 1 and one Grade 3. The Grade 3 event occurred in a patient with central nervous system (CNS) lymphoma. Overall, 84 percent of patients (n=21) had Grade 3/4 treatment-emergent adverse events (TEAEs), and 28 percent (n=7) reported serious TEAEs. The most common Grade 3/4 TEAE was neutropenia, a reduction in white blood cells (72 percent). One patient experienced a Grade 3 infection.1

"We're really excited to share the first results for our dual-targeting anti-CD19/CD20 CAR T-cell therapy in relapsed or refractory large B-cell lymphoma, underscoring our more than decade-long commitment to addressing unmet needs for patients with B-cell malignancies," said Jeffrey Infante, M.D., Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine. "As we continue to unlock the full potential of CAR T-cell therapies through novel next-generation approaches, these promising data reinforce earlier long-term findings and highlight the potential of JNJ-4496 to improve outcomes for patients."

These data are advancing our pipeline of CAR T therapies for the treatment of B-cell malignancies and are an extension of our worldwide collaboration and licensing agreement initiated with AbelZeta Inc. (formerly Cellular Biomedicine Group, Inc.) in 2023 to develop and commercialize next-generation CAR T-cell therapies (excluding Greater China). A Phase 1 study for C-CAR039 was conducted in China for the treatment of patients with B-cell non-Hodgkin lymphoma (predominantly LBCL).3 Johnson & Johnson is also evaluating the safety and efficacy of this asset (known as JNJ-4496 outside of Greater China) through a separate study involving a global patient population.4 In addition to the oral presentation of JNJ-4496 at EHA, the global clinical study data will be presented at the 2025 International Conference on Malignant Lymphoma from June 17—21.

About large B-cell lymphoma
Large B-cell lymphoma is a type of non-Hodgkin lymphoma (NHL), a blood cancer that originates in the lymphatic system, arising from abnormal B cells, a type of white blood cell responsible for producing antibodies to fight infections.2 The malignant cells grow rapidly in lymph nodes or other organs and can spread quickly throughout the body.2 These abnormal cells are larger than normal, healthy B-cells.2 Diffuse (D) LBCL is the most common and aggressive type where cells are spread out (diffuse) rather than grouped together when they are examined under a microscope.2 DLBCL accounts for approximately 40 percent of all NHL cases globally and is estimated to have 150,000 new cases diagnosed each year.5 While some patients respond to initial treatment, up to 40 percent can relapse or become refractory to therapy.6 LBCL and DLBCL patients often face limited treatment options and a poor prognosis, highlighting the urgent need for innovative therapies. Common symptoms include rapidly growing lymph nodes, fever, night sweats, weight loss, and fatigue.2

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at https://www.innovativemedicine.jnj.com. Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen Global Services, LLC are Johnson & Johnson companies.

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of JNJ-90014496. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Footnotes:

* Dr. Krish Patel, Director of Lymphoma Research, Sarah Cannon Research Institute (SCRI), U.S., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 

1 Patel K et al. A Global Phase 1b Study Of JNJ-90014496, A CD19/CD20 Bi-Specific Chimeric Antigen Receptor (CAR) T-Cell Therapy, In Patients (Pts) With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL). 2025 European Hematology Association. https://library.ehaweb.org/eha/2025/eha2025-congress/4159316/matthew.ku.a.global.phase.1b.study.of.jnj-90014496.a.cd19.cd20.bi-specific.html. Last accessed June 2025.
2 Lymphoma Action. Diffuse Large B-Cell Lymphoma. https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/diffuse-large-b-cell-lymphoma. Last accessed June 2025.
3 ClinicalTrials.gov. Study of C-CAR039 in relapsed/refractory B-cell non-Hodgkin lymphoma. Identifier NCT05149391. https://clinicaltrials.gov/study/NCT05149391?term=C-CAR039&rank=1. Accessed June 2025.
4 Clinicaltrials.gov. A Phase 1b Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CART-Cell Therapy in Adult Participants With B-Cell Non-Hodgkin Lymphoma. Identifier NCT05421663. https://clinicaltrials.gov/study/NCT05421663. Last accessed June 2025.
5 Berhan A et al. Diffuse large B cell lymphoma (DLBCL): epidemiology, pathophysiology, risk stratification, advancement in diagnostic approaches and prospects: narrative review. Discov Oncol. 2025 Feb 15;16:184. https://link.springer.com/content/pdf/10.1007/s12672-025-01958-w.pdf. Last accessed June 2025.
6 García-Sancho AM et al. Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma: New Approved Options. J Clin Med. 2023 Dec 22;13(1):70. https://www.mdpi.com/2077-0383/13/1/70. Last accessed June 2025.

Media contact: 
 

Oncology Media Relations 
Oncology_media_relations@its.jnj.com  

Investor contact: 
 

Lauren Johnson 
investor-relations@its.jnj.com 

 

U.S. medical inquiries: 
+1 800 526-7736 

 

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SOURCE Johnson & Johnson

FAQ

What are the key results of JNJ's new CAR T-cell therapy clinical trial?

The trial showed 80% complete response rate in patients with one prior treatment and 75% in those with multiple prior treatments, with 100% and 92% objective response rates respectively.

What makes JNJ-90014496 different from other CAR T-cell therapies?

It's a dual-targeting therapy designed to bind both CD19 and CD20 antigens on B-cells, potentially offering better efficacy than current single-antigen therapies that achieve only 40% long-term remission.

What are the main side effects of JNJ's new CAR T-cell therapy?

The main side effects include Grade 3/4 neutropenia in 72% of patients, with 84% experiencing Grade 3/4 treatment-emergent adverse events, though notably no Grade 3/4 cytokine release syndrome was observed.

What is the recommended Phase 2 dose for JNJ-4496?

The recommended Phase 2 dose is 75 million CAR+ T-cells.

How many patients were included in JNJ's CAR T-cell therapy study?

The efficacy was assessed in 22 patients at the recommended Phase 2 dose, with 25 patients in the safety evaluation group.
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