Drugs / CNCT19
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | acute lymphoblastic leukemia | 2022-12-15 | “today announces that China National Medical Products Administration (NMPA) has accepted the new drug application (NDA) from Juventas Cell Therapy, Ltd., (Juventas) for CNCT19” issuerdirect.com ↗ |
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT07275736 | Mar 2025 → Jun 2027 expected | autoimmune disorder of the nervous system | Juventas Cell Therapy Ltd. | Recruiting | No outcome recorded |
| Phase 0 | NCT05930314 | Jun 2023 → May 2024 | autoimmune thrombocytopenia, lupus nephritis, systemic lupus erythematosus | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT06316791 | Dec 2021 → Dec 2025 overdue | systemic lupus erythematosus | Juventas Cell Therapy Ltd. | Recruiting | No outcome recorded |
| Phase 0 | NCT04011293 | Jul 2019 → Jul 2020 | refractory hematologic cancer | Shandong University | Unknown | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT06676982 | Jan 2025 → Jul 2026 overdue | hepatocellular carcinoma | Zhejiang University | Recruiting | No outcome recorded |
| Phase 1 | NCT06231368 | Feb → Nov 2024 overdue | autoimmune hemolytic anemia | Institute of Hematology & Blood Diseases Hospital, China | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04230473 | Mar → Dec 2020 | acute lymphoblastic leukemia | Juventas Cell Therapy Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04232826 | Jan 2020 → Jan 2021 | non-Hodgkin lymphoma | Juventas Cell Therapy Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03029338 | Jun 2017 → May 2019 | aggressive B-cell non-Hodgkin lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05667506 | Feb 2023 → May 2025 overdue | B-cell acute lymphoblastic leukemia | Juventas Cell Therapy Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04690192 | Jan 2021 → Dec 2023 | large B-cell lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04684147 | Dec 2020 → Sep 2022 overdue | acute lymphoblastic leukemia | Juventas Cell Therapy Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT04586478 | Oct 2020 → Mar 2024 overdue | non-Hodgkin lymphoma | Juventas Cell Therapy Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2023-11-14 | CASI pharmaceuticals, Inc. | Regulatory CASI PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2023 BUSINESS AND FINANCIAL UPDATES issuerdirect.com ↗ |
| 2023-11-08 | CASI pharmaceuticals, Inc. | Regulatory CASI PHARMACEUTICALS ANNOUNCES MARKET APPROVAL OF CNCT19 BY CHINA NMPA issuerdirect.com ↗
The China National Medical Products Administration (NMPA) has granted market approval for Juventas' investigational cell therapy, Inaticabtagene Autoleucel (CNCT 19), for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China . |
| 2022-12-15 | CASI pharmaceuticals, Inc. | Regulatory CASI PHARMACEUTICALS' PARTNER JUVENTAS ANNOUNCES NEW DRUG APPLICATION FOR CNCT19 ACCEPTED BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION issuerdirect.com ↗
CASI PHARMACEUTICALS' PARTNER JUVENTAS ANNOUNCES NEW DRUG APPLICATION FOR CNCT19 ACCEPTED BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION |
| 2022-01-18 | CASI pharmaceuticals, Inc. | Regulatory CASI PHARMACEUTICALS ANNOUNCES CNCT19 (CD19 CAR-T) GRANTED ORPHAN DRUG DESIGNATION BY THE U.S. FDA issuerdirect.com ↗ |
| 2020-12-23 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Announces CNCT19 (CD19 CAR-T) Receives China Breakthrough Therapy Designation issuerdirect.com ↗
The Breakthrough Designation for CNCT19 was granted based on initial data from the ongoing single arm, open-label, non-randomized, dose-escalation, Phase I study designed to determine the safety and efficacy of CNCT19 in B-ALL. |
| 2019-12-03 | CASI pharmaceuticals, Inc. | Regulatory CASI Pharmaceuticals Announces China NMPA Approval Of CNCT19 (CD19 CAR-T) Clinical Trial Applications issuerdirect.com ↗
CASI Pharmaceuticals Announces China NMPA Approval Of CNCT19 (CD19 CAR-T) Clinical Trial Applications |
| 2019-09-16 | CASI pharmaceuticals, Inc. | Regulatory China NMPA Accepts Clinical Trial Application For CASI's CD19 CAR-T-Product issuerdirect.com ↗ |
All press releases naming this drug 10 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CNCT19 | “CNCT19 is a second-generation CAR T-cell with a scFv derived from clone HI19α and a 4-1BB costimulatory domain.” PMID 40960310 ↗ Sep 202512“All subjects were intravenous administrated with CNCT19 CAR-T.” NCT06676982 ↗ |
| Known as | CNCT19s | “safety and preliminary efficacy of CNCT19 cells (CNCT19s) in patients with relapsed or refractory (R/R) aggressive B-cell lymphoma.” PMID 40960310 ↗ Sep 2025 |
| Action | Deplete | “CD19-directed chimeric antigen receptor (CAR) T-cell therapy results in profound B-cell depletion” PMID 41534043 ↗ Jan 2026 |
| Modality | Cell therapy | “CNCT19 is a second-generation CAR T-cell with a scFv derived from clone HI19α and a 4-1BB costimulatory domain.” PMID 40960310 ↗ Sep 2025 |
| Route | Intravenous | “administered by i.v. injection” NCT03029338 ↗ |
| Target | CD19 | “anti-CD19 scFv” NCT03029338 ↗ |