Drugs / Relmacabtagene Autoleucel
Relmacabtagene Autoleucel
also known as
relma-cel · JWCAR029 · Carteyva · CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Cell therapy targets CD19
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT06414135 | Jun 2024 → May 2025 overdue | systemic sclerosis | Liangjing Lu | Recruiting | No outcome recorded |
| Phase 1 | NCT06297408 | Mar 2024 → May 2025 | systemic lupus erythematosus | Shanghai Ming Ju Biotechnology Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05765006 | Feb 2023 → Dec 2024 | systemic lupus erythematosus | Shanghai Ming Ju Biotechnology Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05727683 | Apr 2022 → Oct 2023 | acute lymphoblastic leukemia | Shanghai Ming Ju Biotechnology Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05259813 | Feb 2022 → Jan 2023 | B-cell chronic lymphocytic leukemia | Shanghai Ming Ju Biotechnology Co., Ltd. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04812691 | Jul 2020 → Jun 2021 | diffuse large B-cell lymphoma | Shanghai Ming Ju Biotechnology Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03355859 | Jan 2018 → Dec 2019 | non-Hodgkin lymphoma | Zhao Weili | Unknown | No outcome recorded |
| Phase 1 | NCT03344367 | Nov 2017 → Oct 2019 | non-Hodgkin lymphoma | Peking University | Unknown | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT07326371 | Mar 2026 → Jul 2027 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07077512 | Sep 2025 → Jan 2027 expected | diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06479356 | Aug 2024 → Apr 2025 overdue | large B-cell lymphoma, non-Hodgkin lymphoma | Shanghai Ming Ju Biotechnology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT06365671 | Apr 2024 → Apr 2026 overdue | B-cell non-Hodgkin lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06876688 | Nov 2023 → Nov 2028 expected | lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06093841 | Nov 2023 → Jan 2024 overdue | high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma | Shanghai Ming Ju Biotechnology Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06149169 | Aug 2023 → Oct 2024 | diffuse large B-cell lymphoma | Shanghai Ming Ju Biotechnology Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT05590221 | Jan 2023 → Feb 2024 | large B-cell lymphoma | Peking University Cancer Hospital & Institute | Unknown | No outcome recorded |
| Phase 2 | NCT04718883 | Jan 2021 → Oct 2023 overdue | mantle cell lymphoma | Shanghai Ming Ju Biotechnology Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04089215 | Jun 2019 → Sep 2021 | diffuse large B-cell lymphoma, follicular lymphoma | Shanghai Ming Ju Biotechnology Co., Ltd. | Unknown | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT05814848 | Jun 2023 → Mar 2028 expected | B-cell non-Hodgkin lymphoma | Changhai Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05806580 | May 2023 → May 2027 expected | B-cell non-Hodgkin lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07198464 | Oct 2025 → Oct 2029 expected | primary central nervous system lymphoma | Zhengzhou University | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT05370547 Background | May 2022 → Jun 2024 | non-Hodgkin lymphoma | Chinese PLA General Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-09-08 | Shanghai JW Therapeutics Co., Ltd. | Regulatory JW Therapeutics Announces NMPA Approval to Extend Cryopreservation Period of Sorted T Cells for Carteyva® to 36 Months, Further Enhancing CAR-T Manufacturing and Clinical Value jwtherapeutics.com ↗
JW Therapeutics (HKEX: 2126), a biotechnology company dedicated to advancing innovative cell immunotherapies, announced that the post-marketing supplemental application for its proprietary anti-CD19 autologous CAR-T cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection, relma-cel) has been officially approved by the National Medical Products Administration (NMPA). |
| 2026-06-09 | Shanghai JW Therapeutics Co., Ltd. | Results EULAR 2026 | JW Therapeutics Presents Two Positive Study Results of Relma-cel for SLE and SSc at the European Congress of Rheumatology jwtherapeutics.com ↗
The Phase 1 results presented at EULAR 2026 further validate the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases and provide an important basis for advancing relma-cel into Phase 2 clinical studies. |
| 2026-03-06 | Shanghai JW Therapeutics Co., Ltd. | Results JW Therapeutics' Relma-cel IIT Study in Systemic Sclerosis (SSc) Selected as Late-Breaking Abstract at the Systemic Sclerosis World Congress (SSWC) jwtherapeutics.com ↗
The study explored the molecular characteristics of CD19 CAR-T therapy in patients with systemic sclerosis, and the results showed that relma-cel was well-tolerated and demonstrated promising efficacy in patients with progressive diffuse cutaneous SSc. |
| 2025-12-07 | Shanghai JW Therapeutics Co., Ltd. | Regulatory JW Therapeutics' Carteyva® Successfully Included in the First Edition of the National Healthcare Security Administration's Commercial Health Insurance Innovative Drug Directory jwtherapeutics.com ↗
The successful inclusion of Carteyva® in the NHSA's Commercial Health Insurance Innovative Drug Directory signifies that the clinical value and innovativeness of this cutting-edge cell immunotherapy product have received high-level national recognition. |
| 2025-10-21 | Shanghai JW Therapeutics Co., Ltd. | Regulatory JW Therapeutics Submitted data from the Phase I study of Relma-cel in Chinese adult patients with active systemic lupus erythematosus to China National Medical Products Administration jwtherapeutics.com ↗
NMPA accepted both data and meeting application. |
| 2025-10-09 | Shanghai JW Therapeutics Co., Ltd. | Regulatory National Medical Products Administration has officially accepted the post-marketing supplemental application for Carteyva®, which uses an in-house produced lentiviral vector jwtherapeutics.com ↗
JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China has officially accepted its post-marketing supplementary application for Carteyva® to add the use of in-house produced lentiviral vector. |
| 2025-06-04 | Shanghai JW Therapeutics Co., Ltd. | Regulatory JW Therapeutics Announces Approval of Carteyva® (Relmacabtagene Autoleucel Injection) for Marketing in Macao jwtherapeutics.com ↗
As JW Therapeutics' first commercial product, the marketing approval of Carteyva® in Macao will further expand its accessibility in hematological oncology. |
| 2025-05-28 | Shanghai JW Therapeutics Co., Ltd. | Regulatory NMPA ACCEPTANCE OF THE SUPPLEMENTAL BIOLOGICAL LICENSE APPLICATION FOR CARTEYVA® AS SECOND-LINE TREATMENT IN RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA INELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANTATION jwtherapeutics.com ↗
JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration of China (“NMPA”) accepted the supplemental Biological License Application (“sBLA”) for its cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) as second-line treatment in relapsed or refractory large B-cell lymphoma (“r/r LBCL”). |
| 2025-01-10 | Shanghai JW Therapeutics Co., Ltd. | Regulatory Receipt of Breakthrough Therapy Designation for Carteyva® in China as Second-line Treatment in Relapsed or Refractory adult Large B-cell Lymphoma jwtherapeutics.com ↗
granted Breakthrough Therapy Designation for Carteyva® (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) |
All press releases naming this drug 9 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Relmacabtagene Autoleucel | “Relmacabtagene autoleucel (relma-cel) is the second anti-CD19 CAR-T product approved for marketing by the National Medical Products Administration (NMPA) in China” PMID 40386685 ↗ Apr 202510“This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.” NCT06149169 ↗ “Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China.” PMID 33382529 ↗ Dec 2020 “JWCAR029 (Relmacabtagene Autoleucel)” NCT05259813 ↗ |
| Known as | Carteyva | “Preliminary efficacy and safety of Relmacabtagene autoleucel (Carteyva) in adults with relapsed/refractory follicular lymphoma in China: A phase I/II clinical trial.” PMID 36053875 ↗ Sep 2022 |
| Known as | CD19-targeted Chimeric Antigen Receptor (CAR) T Cells | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04718883 ↗ |
| Known as | JWCAR029 | “Relma-cel (JWCAR029), an anti-CD19 product produced with a commercial-ready process in China, was evaluated in the first prospective, single-arm, multicenter, pivotal study of...” PMID 33382529 ↗ Dec 20205“A Phase I Open, Single-arm Study of JWCAR029 (CD19-targeted Chimeric Antigen Receptor T Cells) for Patients With Relapsed or Refractory in B-cell Acute Lymphoblastic Leukemia” NCT05727683 ↗ |
| Known as | relma-cel | “This is a prospective, open-label, multicenter, single-arm trial, assessed the efficacy and safety of JWCAR029(relma-cel) as part of first-line therapy after an incomplete...” NCT05590221 ↗11“A single infusion of CAR-transduced autologous T cells administered intravenously at a target dose of 100 × 10\^6 for Relma-cel or 2 × 10\^6/kg for Axi-cel.” NCT05370547 ↗ “Relmacabtagene autoleucel (relma-cel) CD19 CAR-T therapy for adults with heavily pretreated relapsed/refractory large B-cell lymphoma in China.” PMID 33382529 ↗ Dec 2020 “An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed and Refractory (R/R) LBCL” NCT06149169 ↗ “Relmacabtagene autoleucel (relma-cel)” NCT06365671 ↗ “Relmacabtagene autoleucel (relma-cel)” NCT07326371 ↗ |
| Action | Deplete | “In all patients treated with relma-cel, CD19+ B cells in peripheral blood were almost completely depleted within 11-15 days and gradually recovered within 2-6 months.” PMID 40386685 ↗ Apr 2025 |
| Modality | Cell therapy | “CD19-targeted Chimeric Antigen Receptor (CAR) T Cells” NCT03355859 ↗ |
| Route | Intravenous | “one dose treatment with JWCAR029 by intravenous (IV) injection” NCT03344367 ↗ |
| Target | CD19 | “CD19-targeted chimeric antigen receptor” NCT03355859 ↗ |