Drug Type Autologous CAR-T |
Synonyms CD19-41BB-tEGFR, CD19-CART (Hrain Biotechnology), CD19-CD28-tEGFR + [4] |
Target |
Mechanism CD19 modulators(B-lymphocyte antigen CD19 modulators), T lymphocyte replacements |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationPriority Review (CN) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
B-cell lymphoma recurrent | NDA/BLA | CN | 14 Dec 2023 | |
B-cell lymphoma refractory | NDA/BLA | CN | 14 Dec 2023 | |
CD19 positive Acute Lymphoblastic Leukemia | Phase 1 | CN | 13 Mar 2019 | |
CD19 Positive B-Cell Leukemia | Phase 1 | CN | 13 Mar 2019 | |
CD19 Positive Lymphoma | Phase 1 | CN | 13 Nov 2018 | |
Diffuse Large B-Cell Lymphoma | Phase 1 | CN | 13 Nov 2018 | |
Follicular Lymphoma | Phase 1 | CN | 13 Nov 2018 | |
CD19-positive B-cell acute lymphoblastic leukemia | Phase 1 | CN | 12 Nov 2018 |
Phase 2 | 81 | sfegcrrrja(bohvpdjgcv) = nwoltangmt jibffwokni (zzxrlmcwum, 22.2 ~ 43.4) View more | Positive | 05 Apr 2024 | |||
Phase 1 | CD19 positive Acute Lymphoblastic Leukemia CD19 Positive | 9 | rfwaidkwrz(nukdwkdoqy) = the incidence of acute graft-versus-host disease or extensive chronic graft-versus-host disease did not increase lvnyobasqp (jfucqhtrns ) | Positive | 01 Oct 2020 | ||
NCT02652910 (ASCO2018) Manual | Phase 1 | Non-Hodgkin Lymphoma CD19 Positive | 22 | rlmyneaghd(cpxhbiomqq) = dxosaxnrsz mqjhsqkcwb (hlkcgqddsx ) View more | Positive | 04 Jun 2018 |