Drugs / CT103A
CT103A
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | plasma cell myeloma | 2022-06-02 | “today jointly announced that the China National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for Equecabtagene Autoleucel” iasobio.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04561557 | Sep 2020 → Feb 2027 expected | POEMS syndrome, autoimmune encephalitis, chronic inflammatory demyelinating polyradiculoneuropathy, idiopathic inflammatory myopathy +4 | Tongji Hospital | Recruiting | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT05181501 | Apr 2022 → Apr 2024 overdue | plasma cell myeloma | Nanjing IASO Biotechnology Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05201118 | Jan → Dec 2022 | plasma cell myeloma | Chunrui Li | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05066646 | Apr 2020 → Oct 2022 | plasma cell myeloma | Nanjing IASO Biotechnology Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2026-09-26 | Nanjing IASO Biotechnology Co., Ltd. | Results 2026 IMS | IASO Bio Presented FUCASO China Real-World Data iasobio.com ↗
FUCASO still achieved an objective response rate (ORR) of 95.9% and a complete response (CR) or stringent complete response (sCR) rate of 77.2%, with efficacy consistent with the overall cohort across the elderly, prior anti-CD38-treated, and high-risk cytogenetic subgroups. |
| 2026-09-25 | Nanjing IASO Biotechnology Co., Ltd. | Results 2026 IMS | Updated FUMANBA-1 Analysis of IASO Bio’s FUCASO Reveals That In Vivo Durable Persistence of CAR-T cells Is Associated with Sustained MRD Negativity and Delayed Disease Progression iasobio.com ↗ |
| 2026-08-21 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio's Registration Application for FUCASO® (equecabtagene autoleucel) Accepted by Australia's TGA iasobio.com ↗ |
| 2026-03-24 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Has Received Clearance from Japan’s PMDA to Initiate Clinical Trial for CAR-T Therapy Equecabtagene Autoleucel in Second- or Third-Line Multiple Myeloma iasobio.com ↗ |
| 2025-11-27 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces BLA Approval of Fucaso (Equecabtagene Autoleucel) by the Hong Kong Department of Health for the Treatment of Relapsed or Refractory Multiple Myeloma iasobio.com ↗ |
| 2025-07-09 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Receives Orphan Drug Designation from the Ministry of Food and Drug Safety of South Korea for Equecabtagene Autoleucel iasobio.com ↗
The Orphan Drug Designation granted to Equecabtagene Autoleucel Injection in South Korea marks another significant international regulatory milestone for the product, following its ODD approval in Saudi Arabia in May. |
| 2025-06-23 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio presents promising efficacy of Equecabtagene Autoleucel in patients with Multiple Sclerosis in IIT study at the 11th Congress of the European Academy of Neurology (EAN) iasobio.com ↗
The study has demonstrated that Equecabtagene Autoleucel are well tolerated and highly effective in treating progressive MS. |
| 2025-02-14 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Hong Kong Department of Health iasobio.com ↗ |
| 2024-12-10 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presented Study Findings on the Impact of CAR T-Cell Persistence on Clinical Outcomes in Relapsed/Refractory Multiple Myeloma with Equecabtagene Autoleucel(FUCASO) Myeloma at 2024 ASH iasobio.com ↗
The results highlighted the importance of the efficacy-to-target ratio in the treatment of multiple myeloma, emphasizing the crucial role of sustained CAR T-cell persistence, unaffected by baseline soluble B-cell maturation antigen (sBCMA) levels, to achieve optimal disease control. |
| 2024-11-08 | Nanjing IASO Biotechnology Co., Ltd. | Results JAMA Oncology Publishes Phase 1b/2 Study Data on IASO Bio's Equecabtagene Autoleucel (Fucaso™) in the Treatment of Relapsed/Refractory Multiple Myeloma iasobio.com ↗
The results demonstrated that Equecabtagene Autoleucel achieved a high overall response rate and durable remission in patients, with a a manageable toxicity. |
| 2024-09-29 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presented Comparative Clinical Outcomes on the Optimal Lymphodepletion Prior to Infution of Equecabtagene Autoleucel（FucasoTM）in Patients with Relapsed Refractory Multiple Myeloma at 2024 IMS Annual Meeting iasobio.com ↗ |
| 2024-07-01 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presented Clinical Data and Single-cell Analysis of Equecabtagene Autoleucel for the Treatment of Central Nervous System Autoimmunity in Oral Presentation at EAN 2024 iasobio.com ↗
The study results preliminarily demonstrated the good tolerability and safety, durable pathogenic antibody clearance, and potential clinical efficacy of Eque-cel in NMOSD. |
| 2024-05-11 | Nanjing IASO Biotechnology Co., Ltd. | Results Single-Cell Multi-Omics Analysis of IASO Bio's Equecabtagene Autoleucel in the Treatment of Autoimmune Diseases of the Central Nervous System Published in Science Immunology iasobio.com ↗
This paper focuses on the single-cell multi-omics analysis of the fully human BCMA targeting autologous CAR-T cell injection ( Equecabtagene Autoleucel, Eque-cel, R&D code: CT103A) in the treatment of patients with neuromyelitis optica spectrum disorder (NMOSD) . |
| 2024-04-05 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces U.S. FDA Approval of Investigational New Drug Application for BCMA CAR-T Equecabtagene Autoleucel for Generalized Myasthenia Gravis iasobio.com ↗ |
| 2024-03-29 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces NMPA's IND Approval for Equecabtagene Autoleucel in Second- and Third-Line Treatment of Multiple Myeloma iasobio.com ↗ |
| 2024-02-29 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio’s Equecabtagene Autoleucel for Refractory Myasthenia Gravis (MG) Case Report Published in EMBO Molecular Medicine iasobio.com ↗
B cell lineage reconstitution underlies CAR-T cell therapeutic efficacy in patients with refractory myasthenia gravis, initially demonstrated the good tolerability and safety of Eque-cel in the treatment of MG, as well as the durable clinical efficacy. |
| 2024-02-01 | Nanjing IASO Biotechnology Co., Ltd. | Results Promising Clinical Results on the World’s First Use of BCMA CAR-T to Treat Immune Mediated Necrotizing Myopathy (IMNM) Published on the Proceedings of the National Academy of Sciences (PNAS) iasobio.com ↗ |
| 2023-12-12 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio and Innovent Present New Data of FUCASO® (Equecabtagene Autoleucel) for Multiple Myeloma Patients in Oral Presentation at ASH 2023 iasobio.com ↗
The presentation highlights the characteristics and efficacy of fully human BCMA-targeting CAR-T (Equecabtagene Autoleucel) on multiple myeloma patients who had sustained minimal residual disease (MRD) negativity after receiving treatment. |
| 2023-12-12 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and IASO Bio Present New Data of FUCASO® (Equecabtagene Autoleucel) for Multiple Myeloma Patients in Oral Presentation at ASH 2023 innoventbio.com ↗
The presentation is based on a post-hoc analysis of the FUMANBA-1 study. |
| 2023-09-28 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio Presents Updated Long-Term Follow-Up Data for BCMA CAR-T FUCASO® (Equecabtagene Autoleucel) at IMS 2023 iasobio.com ↗ |
| 2023-07-10 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio and Innovent Announce the NMPA Approval of the NDA for Equecabtagene Autoleucel, the World's First Fully-human BCMA CAR-T Therapy, for the Treatment of RRMM iasobio.com ↗ |
| 2023-07-03 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and IASO Bio Announce the NMPA Approval of FUCASO®, the First Fully-human BCMA CAR-T Therapy, for the Treatment of Relapsed or Refractory Multiple Myeloma innoventbio.com ↗ |
| 2023-07-01 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio and Innovent Updated Efficacy and Safety Clinical Data of Equecabtagene Autoleucel（BCMA CAR-T Cell Therapy）for Multiple Myeloma at the 2023 ASCO Annual Meeting iasobio.com ↗
The updated data showed long-term follow-up efficacy and safety of the phase 1b/2 study (FUMANBA-1) conducted in 14 centers in China. |
| 2023-06-06 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and IASO Bio Updated Efficacy and Safety Clinical Data of Equecabtagene Autoleucel (BCMA CAR-T Cell Therapy) for Multiple Myeloma at the 2023 ASCO Annual Meeting innoventbio.com ↗
The updated data showed long-term follow-up efficacy and safety of the Phase 1b/2 study (FUMANBA-1) conducted in 14 centers in China. |
| 2023-02-13 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces CT103A Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations by the FDA iasobio.com ↗ |
| 2022-12-22 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio Announces U.S. FDA Approval of Clinical Trial Application for BCMA CAR-T CT103A for Relapsed/Refractory Multiple Myeloma iasobio.com ↗
today announced that the Investigational New Drug (IND) application for its BCMA CAR-T CT103A (equecabtagene autoleucel) has been approved by the U.S. Food and Drug Administration (FDA) for use in U.S. clinical trials for relapsed/refractory multiple myeloma (R/R MM). |
| 2022-08-19 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory World's First CAR-T for NMOSD Treatment, IASO Biotherapeutics' Equecabtagene Autoleucel, Receives IND Approval by NMPA iasobio.com ↗
This is the world's first IND approval for CAR-T in NMOSD treatment. |
| 2022-06-13 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Bio and Innovent Present Updated Data of BCMA CAR-T Cell Therapy（Equecabtagene Autoleucel）at EHA 2022 iasobio.com ↗ |
| 2022-06-13 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent and IASO Bio Present Updated Data of BCMA CAR-T Cell Therapy (Equecabtagene Autoleucel) at EHA 2022 innoventbio.com ↗
The updated data from the Phase 1/2 study with a longer duration of follow-up in more patients has showed durable and deepening efficacy, manageable safety and long-term in vivo persistence, indicating that Equecabtagene Autoleucel has the potential to be a breakthrough therapy for patients with R/R MM. |
| 2022-06-06 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent and IASO Bio Jointly Announce the NMPA Acceptance of the New Drug Application for Equecabtagene Autoleucel for the Treatment of Relapsed and/or Refractory Multiple Myeloma innoventbio.com ↗
Equecabtagene Autoleucel is the first CAR-T therapy in China that is self-developed with proprietary whole-process product development and the first BCMA-targeting CAR T-cell therapy in China with its NDA formally accepted by the NMPA. |
| 2022-06-02 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Bio and Innovent Jointly Announce the NMPA Acceptance of the New Drug Application for Equecabtagene Autoleucel for the Treatment of Relapsed and/or Refractory Multiple Myeloma iasobio.com ↗ |
| 2022-05-20 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory IASO Biotherapeutics’ Equecabtagene Autoleucel, the World’s First CAR-T for Treatment of NMOSD, Receives IND Application Acceptance by NMPA iasobio.com ↗ |
| 2022-02-14 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory U.S. FDA Grants Orphan Drug Designation to BCMA CAR-T Cell Therapy Co-Developed by IASO Bio and Innovent iasobio.com ↗
the Office of Orphan Products Development (OOPD) of the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to their fully human anti-B-cell maturation antigen ( BCMA) chimeric antigen receptor (CAR) T-cell therapy |
| 2022-02-14 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory U.S. FDA Grants Orphan Drug Designation to BCMA CAR-T Cell Therapy Co-Developed by Innovent and IASO Bio innoventbio.com ↗
has formally granted Orphan Drug Designation (ODD) to their co-developed fully-human B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR) T-cell therapy (Innovent: IBI326, IASO Bio: CT103A) |
| 2021-12-13 | Nanjing IASO Biotechnology Co., Ltd. | Results IASO Biotherapeutics and Innovent Biologics Announced Updated Clinical Data of BCMA CAR-T Therapy in Oral Presentation at 2021 ASH Annual Meeting iasobio.com ↗ |
| 2021-06-03 | Nanjing IASO Biotechnology Co., Ltd. | Results Clinical trial results of the BCMA CAR-T Co-developed by IASO Biotherapeutics and Innovent commented in American Society of Hematology’s medical journal “Blood” iasobio.com ↗
The maximum concentration of circulating CT103 is lower than other CARs, but it has a median persistence of 308 days, which will likely increase with follow-up. |
| 2021-06-03 | Innovent Biologics (Suzhou) Co. Ltd. | Results Clinical Trial Results of the BCMA CAR-T Co-developed by Innovent and IASO Biotherapeutics Commented in American Society of Hematology’s Medical Journal “Blood” innoventbio.com ↗
The results showed IBI326 has favorable safety profile with mild and controllable cytokine release syndrome (CRS). |
| 2021-02-23 | Nanjing IASO Biotechnology Co., Ltd. | Regulatory The BCMA CAR-T Co-developed by IASO Biotherapeutics and Innovent was Granted Breakthrough Therapy Designation by the NMPA for the Treatment of Relapsed/Refractory Multiple Myeloma iasobio.com ↗
IASO Biotherapeutics (IASO Bio) and Innovent Biologics, Inc. (Innovent, HKEX: 01801), today jointly announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for CT103A, an investigational chimeric antigen receptor (CAR)-T cell therapy co-developed by IASO Bio and Innovent (IASO Bio: CT103A, Innovent: IBI326), for treatment of relapsed/refractory multiple myeloma. |
| 2021-02-23 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory The BCMA CAR-T Co-developed by Innovent and IASO was Granted Breakthrough Therapy Designation by the NMPA for the Treatment of Relapsed/Refractory Multiple Myeloma innoventbio.com ↗
today jointly announce that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for the investigational chimeric antigen receptor (CAR)-T cell therapy co-developed by Innovent and IASO (Innovent development code: IBI326, IASO development code: CT103A), for treatment of relapsed/refractory multiple myeloma. |
| 2019-12-10 | Innovent Biologics (Suzhou) Co. Ltd. | Results Results of Fully-human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by Innovent and IASO BIO Presented at the 2019 ASH Annual Meeting innoventbio.com ↗
With 17 of the 18 patients evaluable, the objective response rate (ORR) was 100% in the study. |
| 2019-06-18 | Nanjing IASO Biotechnology Co., Ltd. | Results Clinical Results of Fully-human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by IASO BIO and Innovent Presented at the 2019 ASCO and EHA Annual Meetings iasobio.com ↗
The data of CT103A presented at both conferences show an impressive efficacy results, persistence and safety profile and an objective response rate (ORR) of 100%. |
| 2019-06-18 | Innovent Biologics (Suzhou) Co. Ltd. | Results Results of Fully-human BCMA CAR-T for the Treatment of Relapsed/Refractory Multiple Myeloma Co-developed by Innovent and IASO BIO Presented at 2019 ASCO and EHA Annual Meetings innoventbio.com ↗
The data of CT103A presented at both conferences show an impressive efficacy results, persistence and safety profile and an objective response rate (ORR) of 100%. |
All press releases naming this drug 57 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CT103A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05201118 ↗ |
| Known as | Equecabtagene Autoleucel | “Equecabtagene autoleucel (Fucaso®), an autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy” PMID 37658205 ↗ Sep 2023 |
| Known as | Fucaso | “Equecabtagene autoleucel (Fucaso®), an autologous anti-B cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR)-T cell therapy” PMID 37658205 ↗ Sep 2023 |
| Action | Deplete | “to eliminate plasma cells in patients with neurological autoimmune diseases driven by abnormal antibody” NCT04561557 ↗ |
| Modality | Cell therapy | “novel CAR-T cell therapy using CT103A cells” NCT04561557 ↗ |
| Route | Intravenous | “receive one dose treatment with CT103A cells by intravenous (IV) infusion” NCT04561557 ↗ |