IM19 CAR-T cells / Beijing Imunopharm, Simcere, Huadong Medicine - LARVOL DELTA

Phase I study of a CD19-directed CAR-T cell therapy for Relapsed/refractory mantle cell lymphomas(MCL) (ASH 2025) - "A total of eleven r/r MCL patients were recruited and received a single or twice infusion of IM19 with dose-escalation from 1*10 8 to 2*10 8 CAR-T cells after three-day conditional regimen of fludarabine (30mg/m 2 ) and cyclophosphamide (300 mg/m 2 ). In summary, IM19 showed good tolerability and efficacy for r/r MCL at doses of 1*10 8 and 2*10 8 CAR-T cells, and a secondary infusion was unbeneficial for improvement of the efficacy. Key words: r/r MCL; CD19 CAR-T; Safety; Efficacy"

CAR T-Cell Therapy • P1 data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma

Phase I Study of a CD19-Directed CAR-T Cell Therapy for Relapsed/Refractory Mantle Cell Lymphomas(MCL) (ASH 2023) - "Lymphodepleting (LD) chemotherapy was administered over 3 days, including fludarabine (30 mg/m2 i.v. daily) and cyclophosphamide (300 mg/m2 i.v. daily), followed 2 days later by intravenous infusion of IM19 at the assigned dose. Initial data from this Phase I study demonstrate that use of IM19 resulted in a high objective response rate, with a low incidence of grade 3 or worse cytokine release syndrome and neurological events in patients with relapsed or refractory MCL. We observed that CAR-T cells cannot expand in vivo after secondary infusion. Therefore, secondary infusion may not be necessary."

CAR T-Cell Therapy • P1 data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology

Phase I Study of a CD19-Directed CAR-T Cell Therapy for Relapsed/Refractory Mantle Cell Lymphomas(MCL) (ASH 2024) - "Lymphodepleting (LD) chemotherapy was administered over 3 days, including fludarabine (30 mg/m2 i.v. daily) and cyclophosphamide (300 mg/m2 i.v. daily), followed 2 days later by intravenous infusion of IM19 at the assigned dose. We observed that CAR-T cells cannot expand in vivo after secondary infusion. Therefore, secondary infusion may not be necessary."

CAR T-Cell Therapy • P1 data • Cardiovascular • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • Pulmonary Embolism • Respiratory Diseases

anti-cd19 Chimeric Antigen Receptor T Cell Therapy for Refractory Systemic Lupus Erythematosus: An Open-label Pilot Study (ACR Convergence 2025) - P=N/A | "Autologous T cells from patients with SLE were transduced with a lentiviral anti-CD19 CAR vector, expanded and reinfused at a dose of 1×106 CAR T cells per kg body weight or 1 ×108 cells into the patients after lymphodepletion with fludarabine and cyclophosphamide. IM19 CAR T cell therapy demonstrated an acceptable safety profile and induced profound circulating B-cell depletion in refractory SLE, which correlated with accelerated serological normalization and clinically meaningful reductions in disease activity. Notably, the study revealed renal response in 50% of participants with refractory lupus nephritis, indicating a selective rather than universal therapeutic effect. These findings underscore the necessity of future large-scale trials with prolonged follow-up durations to evaluate the durability of therapeutic effects and safety profiles of this innovative cellular therapy."

CAR T-Cell Therapy • Clinical • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Renal Disease • Systemic Lupus Erythematosus

Huadong Medicine Co., Ltd.'s Announcement on Acceptance of Application for Registration and Marketing Authorization of Exclusive Commercialization Products [Google translation] (Sina Corp) - "On November 27, 2024, the drug registration and marketing authorization application for IM19 chimeric antigen receptor T cell injection, an autologous CAR-T candidate product targeting CD19 exclusively commercialized by Huadong Medicine Co., Ltd...was accepted by the National Medical Products Administration."

China filing • Lymphoma • Non-Hodgkin’s Lymphoma

IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

CAR T-Cell Therapy • New P1 trial • Glomerulonephritis • IgA Nephropathy • Nephrology • Renal Disease

Huadong Medicine deepens its presence in the CAR-T field and pays a down payment of RMB 125 million to introduce ImmunoChina IM19 CAR-T cell injection [Google translation] (Eastmoney.com) - "...Huadong Medicine...has signed an exclusive product commercialization cooperation agreement with Beijing ImmunoPharma...Huadong Medicine...has obtained the exclusive commercialization rights of ImmunoPharma's...product IM19...in mainland China. Huadong Medicine...will pay ImmunoPharma a down payment of RMB 125 million...The announcement shows that IM19 CAR-T cell injection has successively obtained drug clinical trial approval notices for three indications: relapsed and refractory diffuse large B-cell lymphoma (r/r-DLBCL), acute B-lymphocytic leukemia (B-ALL) and mantle cell lymphoma (MCL), and has all entered the registration clinical research stage. Among them, the research on the last-line treatment of diffuse large B-cell lymphoma is about to complete the Phase II clinical trial....with good clinical efficacy and safety data, and it is expected to submit a drug marketing authorization application in the fourth quarter of 2024."

China approval • Licensing / partnership • Trial status • B Acute Lymphoblastic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

The pivotal clinical study of IM19 CAR-T cells in the treatment of relapsed or refractory aggressive B cell non-Hodgkin lymphomas (ESMO Asia 2023) - P1/2 | "The incidences of CRS and neurotoxicity were 42% and 7%, respectively; no patient experienced grade 3-4 CRS or grade 3-4 neurotoxicity. Conclusions IM19 treatment of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma can achieve a high rate of durable responses, with an extremely low incidence of grade 3 or more severe CRS and neurotoxicity."

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

Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

CAR T-Cell Therapy • New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1/2 | N=58 | Not yet recruiting | Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

CAR T-Cell Therapy • New P1/2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

A durable 4-1BB-based CD19 CAR-T cell for treatment of relapsed or refractory non-Hodgkin lymphoma. (PubMed, Chin J Cancer Res) - "However, the median progression-free survival (mPFS) of 4-1BB-based product Kymriah was shorter than that of CD28-based Yescarta (2.9 monthsvs. 5.9 months), suggesting that Kymriah was limited in the long-term efficacy. Only one patient (4.5%) experienced grade 3 CRS and grade 3 neurotoxicity. These results demonstrated the safety and durable efficacy of a 4-1BB-based CD19 CAR-T, IM19, which is promising for further development and clinical investigation."

CAR T-Cell Therapy • Journal • Hematological Malignancies • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma (clinicaltrials.gov) - P1/2; N=68; Not yet recruiting; Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

CAR T-Cell Therapy • Clinical • New P1/2 trial • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • CD19