SNC103 / Shanghai Simnova Bio - LARVOL DELTA

Sustained CR for more than 30 months! Cenbo Bio's CD19 CAR-NK Phase I clinical trial achieved positive results [Google translation] (163.com) - P1 | N=55 | NCT06206902 | Sponsor: Shanghai Simnova Biotechnology Co.,Ltd. | "...Simnova Biopharmaceuticals announced that its independently developed universal allogeneic CD19 CAR-NK drug SNC103 has successfully completed two Phase I clinical dosings...The first patient was diagnosed with follicular lymphoma 5 years ago...One month later, the Deauville score of PET-CT examination was 3 points, which was evaluated as complete remission (CR) according to the Lugano standard, and remained in CR status 3 months after the re-infusion...The second patient was diagnosed with DLBCL non-GCB type 3 years ago...One month after a single infusion in the second dose group, the patient was evaluated as partial remission (PR) according to the Lugano standard efficacy assessment. The patient is currently in good general condition and is being followed up....The company plans to include approximately 20 patients in the Phase I trial and expects to release more safety and efficacy data in 2025."

P1 data • Trial status • Diffuse Large B Cell Lymphoma • Follicular Lymphoma

F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Shanghai Simnova Biotechnology Co.,Ltd.

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

F01 in the Treatment of Relapsed/Refractory Non-hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=55 | Recruiting | Sponsor: Shanghai Simnova Biotechnology Co.,Ltd. | Initiation date: Jan 2024 ➔ Apr 2024

Trial initiation date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

F01 in the Treatment of Autoimmune Diseases (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: RenJi Hospital

New P1 trial • Immunology

F01 in the Treatment of Relapsed/Refractory Non-hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=55 | Recruiting | Sponsor: Shanghai Simnova Biotechnology Co.,Ltd.

New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Anti-CD19 CAR-Engineered NK Cells in the Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=2 | Completed | Sponsor: Shanghai Simnova Biotechnology Co.,Ltd. | Recruiting ➔ Completed | N=21 ➔ 2 | Trial completion date: Jul 2024 ➔ Nov 2022 | Trial primary completion date: Jul 2023 ➔ Nov 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

Anti-CD19 CAR-Engineered NK Cells in the Treatment of Relapsed/Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Shanghai Simnova Biotechnology Co.,Ltd.

New P1 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

Cord Blood Derived Anti-CD19 CAR-Engineered NK Cells for B Lymphoid Malignancies (clinicaltrials.gov) - P1; N=27; Recruiting; Sponsor: Wuhan Union Hospital, China

Clinical • New P1 trial • Acute Lymphocytic Leukemia • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology