Drugs / zevor-cel
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | relapsed/refractory diffuse large B-cell lymphoma | 2022-10-18 | “announces that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for zevorcabtagene autoleucel” carsgen.com ↗ “CT053 NDA was submitted to NMPA in October 2022” carsgen.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03915184 | Sep 2019 → Dec 2024 overdue | plasma cell myeloma | CARsgen Therapeutics Co., Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-12-07 | CARsgen Therapeutics Co., Ltd. | Regulatory CARsgen’s CAR-T Product Zevor-Cel Included in China’s Commercial Health Insurance Innovative Drug Catalogue carsgen.com ↗
zevorcabtagene autoleucel (zevor-cel, R&D code: CT053), has been included in China's Commercial Health Insurance Innovative Drug Catalogue (2025) |
| 2025-09-18 | CARsgen Therapeutics Co., Ltd. | Results CARsgen Presents Updated Long-term Follow-up Results for Zevor-cel at IMS 2025 carsgen.com ↗
The overall response rate was 100% (95% CI: 76.8, 100.0) with 11 (78.6%) patients achieving complete response (CR) or stringent complete response (sCR). |
| 2024-11-06 | CARsgen Therapeutics Co., Ltd. | Results CARsgen ® to Present Zevor-cel, CT071 and CT0590 at ASH 2024 Annual Congress carsgen.com ↗
In 102 patients with RRMM who had received at least 3 prior lines of therapy including an immunomodulatory drug and a proteasome inhibitor, the objective response rate (ORR) was 92.2%, the stringent complete response (sCR) or complete response (CR) was 71.6% |
| 2024-11-01 | CARsgen Therapeutics Co., Ltd. | Regulatory CARsgen ® U.S. Clinical Holds Lifted by FDA carsgen.com ↗ |
| 2024-06-17 | CARsgen Therapeutics Co., Ltd. | Results CARsgen Presents Phase II Results on Zevorcabtagene Autoleucel and First-in-human CT071 Results at EHA 2024 carsgen.com ↗
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the updated results of zevorcabtagene autoleucel (zevor-cel; R&D code: CT053, an autologous CAR T-cell product targeting BCMA) and CT071 (an autologous CAR T-cell product targeting GPRC5D) have been presented at the 29th Annual Congress of the European Hematology Association (“EHA”). |
| 2024-03-01 | CARsgen Therapeutics Co., Ltd. | Regulatory NMPA Approves the NDA for CARsgen's BCMA CAR-T Therapy Zevorcabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma carsgen.com ↗ |
| 2023-12-12 | CARsgen Therapeutics Co., Ltd. | Results CARsgen Presents Updated Research Results on Zevor-cel at 2023 ASH Annual Meeting carsgen.com ↗
Herein, the Company presented the updated results with 3 years of follow-up after the last patient was infused with zevor-cel in the Phase I portion of the study. |
| 2022-12-12 | CARsgen Therapeutics Co., Ltd. | Results CARsgen Presents Data from China Pivotal Phase II Trial of BCMA CAR T Zevor-cel (CT053) at 2022 ASH Annual Meeting carsgen.com ↗
This poster reports for the first time the pivotal phase II safety and efficacy data of LUMMICAR STUDY 1. |
| 2022-10-18 | CARsgen Therapeutics Co., Ltd. | Regulatory CARsgen Announces NDA Acceptance of BCMA CAR T Zevor-cel (CT053) by China NMPA carsgen.com ↗
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for zevorcabtagene autoleucel (“zevor-cel,” R&D code: CT053), a fully human, autologous BCMA CAR T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM). |
| 2022-09-21 | CARsgen Therapeutics Co., Ltd. | Results CARsgen Presents North America Phase 2 Updates for CT053 BCMA CAR T at the 7th Annual CAR-TCR Summit carsgen.com ↗
In the 11 evaluable patients who had at least eight weeks follow-up, including four patients with EMD, the objective response rate was 100% (very good partial response, complete response, or stringent complete response) and responses deepened for patients with longer follow-up. |
| 2022-07-19 | CARsgen Therapeutics Co., Ltd. | Results Haematologica Publishes Results from the Investigator-Initiated Trials of CARsgen's CT053 BCMA CAR T-Cell Therapy in Multiple Myeloma carsgen.com ↗
We found that CT053 demonstrated an acceptable safety, pharmacokinetic, and efficacy profile. |
All press releases naming this drug 14 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zevor-cel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03915184 ↗ |
| Known as | CT053 | “This is an open label, multi-center, phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T...” NCT03915184 ↗ |
| Modality | Cell therapy | “Chimeric Antigen Receptor T Cells targeting BCMA” NCT03915184 ↗ |