JW THERAP-B (02126) announced the presentation of JWCAR201 IIT study data at the 67th American Society of Hematology (ASH) Annual Meeting. JWCAR201 is an autologous CAR-T product targeting CD19/CD20, independently developed by JW THERAP-B.
The updated data comes from a single-arm, open-label, multicenter, dose-exploration IIT study conducted in China. The starting dose was set at 25×10^6 CAR+ T cells, with a two-stage CRM-designed dose-escalation rule exploring three dose levels: 25×10^6, 50×10^6, and 100×10^6 CAR+ T cells. The study aimed to evaluate the safety and preliminary efficacy of JWCAR201 in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
As of October 30, 2025, seven enrolled subjects had completed JWCAR201 infusion, with preliminary assessments of safety, efficacy, pharmacokinetics, and pharmacodynamics (PK/PD) across the three dose groups. The median age of the seven infused patients was 56 years (range: 42–72), with 42.9% being male. The cohort exhibited high-risk characteristics: 85.7% had DLBCL-NOS, 57.1% were non-GCB subtype, 57.1% had an International Prognostic Index (IPI) score ≥3, 71.4% had double-expressor lymphoma (MYC/BCL2), 28.6% had bulky disease (≥7 cm), and 42.9% had P53 abnormalities. Additionally, 42.9% had received ≥3 prior lines of therapy, 71.4% were primarily refractory, and 85.7% were resistant to their last treatment. All patients had disease progression despite prior therapies, highlighting the urgent need for new treatments.
Preliminary results as of October 30, 2025, showed a best overall response rate (ORR) of 100% (7/7) and a complete response rate (CRR) of 85.7% (6/7). Except for one patient who withdrew at D90 with partial response (PR), the remaining six maintained responses until D180 or longer follow-up. Median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not yet reached, demonstrating promising efficacy.
Safety data revealed that among the seven infused patients: 42.9% (3/7) experienced grade 1 cytokine release syndrome (CRS), and 14.3% (1/7) had grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS). No high-grade CRS/ICANS or dose-limiting toxicities (DLT) occurred. All patients had treatment-related adverse events, primarily manageable hematologic toxicities (neutropenia, thrombocytopenia, anemia), which resolved to baseline or fully recovered. These findings suggest JWCAR201 is safe and controllable for r/r DLBCL.
The study is ongoing to accumulate longer-term follow-up data. Based on these results, JW THERAP-B believes JWCAR201 demonstrates outstanding efficacy, favorable safety, and strong potential for accelerated IND-stage advancement. The company remains committed to expediting the development of this innovative therapy.