Carteyva (relmacabtagene autoleucel) / JW (Cayman) Therap - LARVOL DELTA

Survival Benefit of Relmacabtagene Autoleucel Versus Usual Care in Relapsed/Refractory Follicular Lymphoma: A Matching-Adjusted Indirect Analysis. (PubMed, Hematol Oncol) - P2 | "At 24 months, 100% of patients survived after relma-cel infusion, versus 38.2% after usual care in China and 62.7% after usual care treatment in SCHOLAR-5, respectively. Relma-cel exhibits superior survival benefits versus current conventional therapies in r/r FL patients after ≥ 2 treatment lines."

Clinical • Journal • Observational data • Retrospective data • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

...Phase 1 clinical study in relapsed/refractory systemic lupus erythematosus (SLE)... (JW Therapeutics Press Release) - "As of August 13, 2025, 12 patients were enrolled and assigned to receive relma-cel at doses of 50 (n=3), 75 (n=3), or 100 × 10⁶ cells (n=6). All participants were female, with a median age of 27 years and median disease duration of 9.5 years. All patients had renal involvement (BILAG A/B) and had received at least two classes of standard SLE therapies. The maximum tolerated dose was not reached. Grade 1 CRS occurred in 11 patients (92%), resolving after a median of 5.6 days with tocilizumab or glucocorticoids. One patient (8%) in the 75 × 106 group experienced grade 2 ICANS, which resolved within 4 days with sedative and antiepileptic therapy. No grade ≥ 2 CRS, grade 1 ICANS, or dose-limiting toxicities were reported. All 12 patients completed ≥ 6 months of follow-up. All (100%) achieved SRI-4 response, 50% (6/12) attained LLDAS, and 25% (3/12) met the DORIS remission criteria....supporting further development in the phase 2 portion of this study in China."

P1 data • Systemic Lupus Erythematosus

JW Therapeutics (HKEx: 2126) today announced the presentation of...longitudinal multi-omic analysis study in systemic sclerosis (SSc). (JW Therapeutics Press Release) - "Single-cell RNA analysis of peripheral blood mononuclear cells identified 7,486 B cells, subclustered into naïve B cells, memory B cells (switched and non-switched), age-associated B cells, and antibody-secreting cells. Naïve B cell proportion increased by day 90 (D90), while plasma cell proportion was markedly reduced. Memory B cells (switched) decreased at D90 and partially recovered by D180, reflecting post-treatment immune remodeling. Single sample gene set enrichment analysis (ssGSEA) revealed downregulation of B-cell activation, differentiation, and BCR signaling pathways by D180. IGHG and IGHA isotypes were largely eliminated post-treatment and did not return to baseline by D180. Clonal expansion and diversity among B-cell subtypes were reduced."

P1 data • Systemic Sclerosis

REAL-WORLD OUTCOMES OF RELMACABTAGENE AUTOLEUCEL (RELMA-CEL) IN R/R LARGE B-CELL LYMPHOMA (EHA 2026) - P | "No grade 5 CRS or NT events were reported. Summary/Conclusion The study indicates that relma-cel is an effective treatment for adult patients with R/R LBCL with a favorable and manageable safety profile in the real-world setting."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Inherited Retinal Dystrophy • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Ophthalmology

SAFETY AND EFFICACY OF RELMACABTAGENE AUTOLEUCEL (RELMA-CEL) IN ADULT PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA:RESULTS FROM AN OPEN-LABEL, SINGLE-ARM STUDY (EHA 2026) - "Following by lymphodepleting chemotherapy with cyclophosphamide (250 mg/m 2 /day × 3 days) and fludarabine (25 mg/m 2 /day × 3 days), and then received a single infusion of relma-cel at a dose of 100 × 10 6 CAR + T cells...Prior therapies included ≥3 lines in 41.7% of patients; 25.0% had received polatuzumab vedotin and 25.0% had received CD3/CD20 bispecific antibodies (one patient was primary refractoriness, two patients were relapsed within 12 months of first-line therapy, and three patients were subsequently treated with bispecific antibodies, and all were refractory to bispecific antibody)...Summary/Conclusion Relma-cel manufactured using the domestically produced lentiviral vector demonstrated favorable efficacy and a manageable safety profile in adult patients with R/R LBCL. These findings support the feasibility of in-house lentiviral vector manufacturing without compromising clinical performance."

Clinical • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

Complete Dose Escalation of Relma-cel, a CD19-Directed Autologous CAR-T Cell Therapy, in Relapsed/Refractory Systemic Lupus Erythematosus: A Phase 1/2 Clinical Trial (EULAR 2026) - P1 | "Relma-cel, a National Medical Products Administration (NMPA)-approved CD19- directed autologous CAR-T product for hematologic malignancies, was administrated after lymphodepletion with cyclophosphamide and fludarabine for three days...All patients had renal involvement (BILAG A/B) and had received at least two classes of standard SLE therapies; one patient (8%) had prior exposure to biologics (telitacicept)...Grade 1 CRS occurred in 11 patients (92%), resolving after a median of 5.6 days with tocilizumab or glucocorticoids...PK and PD analysis revealed robust CAR-T expansion and complete B-cell depletion, followed by reconstitution of naïve-phenotype B cells after CAR-T decay (Fig 2). Conclusions Phase 1 segment of this ongoing trial demonstrates a favorable safety profile and promising efficacy of relma- cel in SLE, supporting further development in the phase 2 portion of this study in China."

CAR T-Cell Therapy • Clinical • P1/2 data • Hematological Malignancies • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Longitudinal Multi-omic Analysis of CD19 CAR-T Cell Therapy in Systemic Sclerosis Demonstrates Coordinated Immune and Stromal Modulation (EULAR 2026) - P1 | "In a phase 1 open-label trial (NCT06414135), we assessed relmacabtagene autoleucel(relma-cel) in progressive diffuse cutaneous SSc...(F) Violin plot displaying EndMT score of endothelial cells across timepoints. (G) Environment score of fibrosis-associated gene module shown on spatial data."

CAR T-Cell Therapy • IO biomarker • Omic analysis • Stroma • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • CCN1 • CD93 • COL1A1 • COL1A2 • COL3A1 • COL6A1 • COMP • CTGF • CTHRC1 • GDF15 • IFI16 • IL18 • MMP9 • POSTN • SFRP2

Integrated Clinical and Proteomic Profiling of CD19 CAR-T Cell Therapy in Progressive Systemic Sclerosis. (PubMed, Arthritis Rheumatol) - "Relma-cel therapy in SSc patients led to early clinical improvement, supported by CAR T-cell expansion, B-cell depletion, and a favorable safety profile. Proteomic alterations were associated with the observed clinical improvements and suggested broad remodeling of inflammatory and fibrotic pathways. Further studies with larger sample sizes are warranted."

Journal • Fibrosis • Immunology • Inflammation • Scleroderma • Systemic Sclerosis

COST-EFFECTIVENESS ANALYSIS OF RELMACABTAGENE AUTOLEUCEL VERSUS IMMUNOCHEMOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA (R/R LBCL) WHO HAVE FAILED AT LEAST TWO LINES OF SYSTEMIC THERAPY IN CHINA (ISPOR 2026) - "As a domestic CAR-T product, Relma-cel represents a cost-effective option compared to standard salvage therapies for Chinese r/r LBCL patients. The consistency of favorable economic outcomes across two distinct indirect comparison methods reinforces the reliability of these findings, effectively validating the model's conclusions despite the inherent challenges of cross-trial evaluations."

Clinical • Cost effectiveness • HEOR • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

MULTI-OMIC PROFILING OF PATIENTS WITH PROGRESSIVE SYSTEMIC SCLEROSIS UNDERGOING CD19 CAR-T CELL THERAPY (SSWC 2026) - P1 | "In a phase 1 open-label trial (NCT06414135), we assessed relmacabtagene autoleucel (relma-cel) in progressive diffuse cutaneous SSc... Our multi-omic analysis demonstrates that CD19 CAR-T cell therapy induces profound B-cell depletion and remodeling of the immune landscape in patients with progressive SSc. The observed reduction in pathogenic B-cell subsets, autoantibody production, and fibrotic gene module expression correla- tes with clinical improvements in skin and lung involvement. These findings suggest that CAR-T therapy may mitigate disease progression through coordinated modu- lation of adaptive immunity and fibroblast activation."

CAR T-Cell Therapy • Clinical • IO biomarker • Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis • COL1A1 • COL1A2 • COL3A1 • COL6A1 • CTGF • POSTN • SFRP2

Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults. (PubMed, Blood Adv) - P2 | "A total of 70 patients with R/R MCL who had received 1 to 9 previous therapies (including anthracycline or bendamustine chemotherapy, anti-CD20 antibodies, and Bruton tyrosine kinase [BTK] inhibitors) were enrolled. These findings demonstrate that relma-cel offers high response rates, durable remissions, and manageable safety in Chinese patients with R/R MCL. This trial was registered at www.clinicaltrials.gov as #NCT04718883."

Clinical • Journal • P2 data • B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Leukopenia • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Glofitamab Combined With CAR-T Therapy in R/R DLBCL (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Ruijin Hospital

New P2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Psoriatic Arthritis • TP53

Cost-Effectiveness of Chimeric Antigen Receptor (CAR) T-Cell Therapy for Blood Cancers: An Updated Systematic Review. (PubMed, Pharmacoecon Open) - "The findings demonstrate that the cost effectiveness of CAR T-cell therapies is determined by a combination of factors: the relative difference between the cost of the CAR T-cell therapy and comparator, the magnitude of the QALY gains and the WTP thresholds. Their cost- effectiveness does not differ according to therapy product, line of treatment, or country."

HEOR • Journal • Review • Hematological Malignancies • Oncology

Combining axicabtagene ciloleucel (axi-cel) or relmacabtagene autoleucel (relma-cel) with HDT/ASCT in relapsed/refractory large B-cell lymphoma: A single-center experience (ASH 2025) - "Background Three CD19-directed CAR T-cell therapies - axicabtagene ciloleucel (axi-cel), lisocabtagenemaraleucel (liso-cel), and tisagenlecleucel (tisa-cel) - are FDA-approved for relapsed/refractory large B-celllymphoma (R/R LBCL) following ≥2 prior lines of therapy or early relapse within 12 months of first-linetreatment. Ten patients(66.7%) experienced cytokine release syndrome (all grade 1-2), while immune effector cell-associatedneurotoxicity syndrome occurred in 3 patients (20.0%; grade 2 in 1 patient, grade 4 in 2 patients). Notreatment-related mortality or unexpected toxicities were observed.Conclusions The combination of axi-cel/relma-cel with HDT/ASCT demonstrates promising efficacy andacceptable safety in patients with R/R LBCL, representing a viable therapeutic option for transplantation-eligible candidates."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma

Safety and efficacy of CD19/CD22/CD20 multi-targeted CAR-T therapy in patients with refractory/relapsed B-cell non-Hodgkin lymphoma (ASH 2025) - P1 | "Among these, 2 patients were treated with commercial products(relmacabtagene autoleucel or axicabtagene ciloleucel), while the remaining 4 participated in IIT. Notably, CD19/CD20 dual-targeted CAR-T cells showed greater expansion than CD19/CD22CAR-T.ConclusionThe CD19/CD22/CD20 multi-targeted CAR-T therapy demonstrated a favorable safety profile andencouraging efficacy in highly refractory NHL patients failing multiple lines of therapy, including thosewith prior CAR-T failure, antigen loss/downregulation. These promising findings warrant furtherinvestigation in expanded cohorts with long-term follow-up."

Clinical • IO biomarker • B Cell Lymphoma • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • CD19 • CD22 • TP53

Imugene and JW Therapeutics join forces on first-in-class combination for solid tumours (BiotechDispatch) - "The agreement brings together Imugene’s oncolytic virus CF33-CD19 (onCARlytics) and JW’s CD19-directed autologous CAR-T therapy, Carteyva, in a program that spans preclinical studies through to a Phase 1 investigator-initiated clinical trial in China...For Imugene, the collaboration represents a significant validation of its onCARlytics technology, designed to overcome one of the biggest challenges in oncology, which is making solid tumours targetable by CAR-T cells....The program will begin with in vitro and in vivo preclinical studies before progressing to a Phase 1 investigator-initiated trial conducted exclusively in China across leading CAR-T clinical centres. Both companies emphasised that the collaboration includes defined go/no-go milestones to ensure disciplined capital allocation and preserve optionality for further development."

Commercial • Preclinical • Solid Tumor

Quantification of ADA of Humanized CD19 CAR-T Cell Therapy in R/R LBCL (ASH 2023) - "3/30 patients who received second CAR-T cell infusion, 2 of which had 2 infusions of the same product, and 1 of which relapsed after relma-cel infusion and followed by the humanized product... The quantification of ADA is essential and credible, which contributes to the unification of standard. Pre-existing ADA does not affect CAR-T amplification for the first infusion but possibly suggests a negative impact on CAR-T efficacy and amplification of multiple-infusion. However, further research is needed."

CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Safety and Efficacy of Relmacabtagene Autoleucel (relma-cel) in Adults with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL): Updated Results from a Phase II Open-Label Study in China (ASH 2023) - P2 | " The study enrolled patients with confirmed diagnosis of MCL, relapsed or refractory after at least 2 lines of prior therapies including anti-CD20 antibody, anthracycline or bendamustine, and BTKi. In this phase II study, relma-cel continually demonstrated high response rates (best ORR: 78.57%; best CRR: 66.67%) and good tolerability in patients with r/r MCL."

Clinical • P2 data • B Cell Non-Hodgkin Lymphoma • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Zhengzhou University

New trial • Bone Marrow Transplantation • CNS Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Central Nervous System Lymphoma • Transplantation

Preliminary safety and efficacy of relmacabtagene autoleucel (relma-cel) in adults with moderately to severely active systemic lupus erythematosus: a phase I dose-escalation study. (PubMed, J Autoimmun) - "Relma-cel demonstrates a manageable safety profile and promising efficacy in patients with moderately to severely active SLE. A dose of 100 × 106 CAR-T cells was identified as the recommended phase II dose based on clinical response and tolerability."

Journal • P1 data • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Clinical outcome and immunophenotype of axicabtagene ciloleucel (axi-cel) and relmacabtagene autoleucel (relma-cel) in relapsed/refractory large B-Cell lymphoma on Chinese population: a single-center experience. (PubMed, Ann Hematol) - "In this cohort, CAR-T therapies for r/r large B-cell lymphoma yielded high response rates and promising survival outcomes, with axi-cel showing superior efficacy but higher CRS incidence compared to relma-cel. The study highlights the need for optimal stem-like memory T-cell proportions in CAR-T products for improved efficacy. Prospective multicenter studies are warranted to confirm these findings in larger patient populations."

Clinical data • IO biomarker • Journal • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCR7

Phase 2 Study of Relmacabtagene Autoleucel (CD19 CAR-T) for Relapsed/Refractory Mantle Cell Lymphoma in Chinese Adults. (PubMed, Blood Adv) - P2 | "A total of 70 patients with R/R MCL who had undergone 1-9 prior therapies (including anthracycline or bendamustine chemotherapy, anti-CD20 antibodies, and BTK inhibitors) were enrolled. These findings demonstrate that relma-cel offers high response rates, durable remissions, and manageable safety in Chinese patients with R/R MCL. This trial was registered at www.clinicaltrials.gov as # NCT04718883."

Clinical • Journal • P2 data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Two-year follow-up of relmacabtagene autoleucel in relapsed or refractory follicular lymphoma in RELIANCE study. (PubMed, Br J Haematol) - P2 | "There were no AEs leading to death. Relma-cel demonstrated durable remissions and manageable safety without new safety signals during the 2-year follow-up in patients with R/R FL (ClinicalTrials.gov, NCT04089215)."

Journal • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Oncology

Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology