Medication Juno-B (02126): JWCAR201 IIT study data presented at the 67th Annual Meeting of the American Society of Hematology
Zhitong Finance App News, Pharmaceutical Juno-B (02126) issued an announcement announcing the release of JWCAR201 IIT research data at the 67th Annual Meeting of the American Society of Hematology. JWCAR201 is an autologous CAR-T product targeting CD19/CD20 developed independently by Pharmaceutical Junuo.
The updated data comes from a single-arm, open, multicenter, dose exploration IIT study conducted in China. The starting dose was 25×106 CAR+ T cells, and dose exploration rules designed in two-stage CRM were used to explore the three dose levels of 25×106 CAR+ T cells, 50×106 CAR+ T cells, and 100×106 CAR+ T cells to evaluate the CAR-T cell product JWCAR201 in relapsing/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) patients Safety and initial efficacy.
As of October 30, 2025, 7 participants enrolled in this study completed the JWCAR201 response, and initially completed exploration of safety, efficacy, and pharmacokinetics (PK/PD) in the three dosage groups.
Of the 7 patients returned in this study, the median age of 56 years (range: 42 to 72 years) was 42.9% male. Patients in this cohort showed significant high-risk characteristics: DLBCL-NOS accounted for 85.7%, non-GCB subtypes accounted for 57.1%, international prognostic index (IPI) score 3 or greater accounted for 57.1%, double expression lymphoma (MYC/BCL2) accounted for 71.4%, large lesions (≥7 cm), and 42.9% for P53 abnormalities. In addition, 42.9% of patients have received ≥3 line treatment in the past, 71.4% of patients are inherently difficult to treat, and 85.7% are resistant to the most recent treatment plan. All patients had received various treatment plans before participating in this study. The disease is still progressing, and there is an urgent need for new effective treatments.
As of October 30, 2025, the preliminary results of this study showed that the optimal overall response rate (ORR) of 7 patients reached 100% (7/7), and the complete remission rate (CRR) reached 85.7% (6/7). With the exception of the D90 partial remission (PR) study of 1 patient, the remaining 6 patients all continued to be in remission until D180 or during longer follow-up. The median duration of remission (DOR), progression-free survival (PFS), and overall survival (OS) were not achieved, showing initial significant efficacy.
Preliminary safety results showed that among the 7 patients who had been treated: 3 patients (42.9%) developed grade 1 cytokine release syndrome (CRS); 1 patient (14.3%) developed grade 1 immune-effector cell-related neurotoxicity syndrome (ICANS), no high-grade CRS or ICANS, and no dose limiting toxicity (DLT) occurred. Other adverse events: All patients experienced treatment-related adverse events, mainly due to anticipated and controllable hematologic toxicity, including neutropenia, thrombocytopenia, and anemia, and all returned to baseline or complete recovery. The safety results of this study showed that the treatment of r/R DLBCL with JWCar201 was safe and controllable.
To date, this study is still ongoing to accumulate data for longer follow-up times.
Based on the above research results, the company believes that JWCAR201 has excellent curative efficacy, good overall safety, and controllable adverse reactions, showing great potential for rapid advancement to the IND stage. The company will continue to work to accelerate the development process of this innovative treatment.