Drugs / C-CAR168
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07676266 | Jul 2026 → Nov 2027 expected | autoimmune/inflammatory optic neuropathy, immune-mediated necrotizing myopathy, multiple sclerosis, myasthenia gravis +2 | The Affiliated Hospital of Qingdao University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07341828 | Feb 2026 → Jun 2027 expected | autoimmune encephalitis, multiple sclerosis, neuromyelitis optica, stiff-person syndrome | Huashan Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06249438 | Mar 2024 → Mar 2027 expected | immune-mediated necrotizing myopathy, multiple sclerosis, myasthenia gravis, neuromyelitis optica spectrum disorder with anti-AQP4 antibodies +2 | RenJi Hospital | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06935474 | Jul 2026 → May 2029 | lupus nephritis | AbelZeta Inc. | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-07-27 | Shanghai AbelZeta Ltd. | Regulatory AbelZeta Receives FDA Clearance of Registrational Phase II Trial for C-CAR168 in Refractory Lupus Nephritis abelzeta.com ↗
The FDA clearance to proceed with this multiple-center registrational Phase II trial for C-CAR168 in LN represents an important step forward in the development of this promising new modality for patients with severe, treatment-refractory lupus. |
| 2026-07-20 | Shanghai AbelZeta Ltd. | Regulatory AbelZeta Receives EMA PRIME Designation for C-CAR168 in Lupus Nephritis and Systemic Lupus Erythematosus abelzeta.com ↗
The granting of EMA PRIME designation marks one of the first major regulatory recognitions of a CAR-T therapy for SLE, highlighting both the significant unmet need faced by lupus patients and the potential of this approach to transform treatment. |
| 2025-05-27 | Shanghai AbelZeta Ltd. | Regulatory AbelZeta Receives RMAT Designation for C-CAR168 for the Treatment of Refractory SLE, Including LN abelzeta.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational therapy, C-CAR168, for the treatment of refractory Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN). |
| 2025-05-22 | Shanghai AbelZeta Ltd. | Results AbelZeta Presents New Data on C-CAR168 for the Treatment of Autoimmune Diseases at LUPUS 2025 abelzeta.com ↗
The Principal Investigator (PI) of the Study, Professor Nan Shen from Department of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, presented the early clinical results in patients with refractory autoimmune disease. |
| 2024-11-16 | Shanghai AbelZeta Ltd. | Results AbelZeta Presents Preclinical Data from Study of C-CAR168 for the Treatment of Autoimmune Diseases at ACR Convergence 2024 abelzeta.com ↗ |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Shanghai AbelZeta Ltd. | AbelZeta Receives FDA IND Clearance for Phase 1b/2 Clinical Trial of C-CAR168 in Progressive Multiple Sclerosis abelzeta.com ↗ |
| 2026-07-27 | Shanghai AbelZeta Ltd. | AbelZeta Receives FDA Clearance of Registrational Phase II Trial for C-CAR168 in Refractory Lupus Nephritis abelzeta.com ↗ |
| 2026-07-20 | Shanghai AbelZeta Ltd. | AbelZeta Receives EMA PRIME Designation for C-CAR168 in Lupus Nephritis and Systemic Lupus Erythematosus abelzeta.com ↗ |
| 2025-05-27 | Shanghai AbelZeta Ltd. | AbelZeta Receives RMAT Designation for C-CAR168 for the Treatment of Refractory SLE, Including LN abelzeta.com ↗ |
| 2025-05-22 | Shanghai AbelZeta Ltd. | AbelZeta Presents New Data on C-CAR168 for the Treatment of Autoimmune Diseases at LUPUS 2025 abelzeta.com ↗ |
| 2024-11-16 | Shanghai AbelZeta Ltd. | AbelZeta Presents Preclinical Data from Study of C-CAR168 for the Treatment of Autoimmune Diseases at ACR Convergence 2024 abelzeta.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | C-CAR168 | “This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult...” NCT07341828 ↗3“This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult...” NCT06249438 ↗ “C-CAR168 Autologous C-CAR168 administered by intravenous (IV) infusion” NCT07676266 ↗ |
| Modality | Cell therapy | “an autologous bi-specific CAR-T therapy targeting CD20 and BCMA” NCT06249438 ↗ |
| Route | Intravenous | “Autologous C-CAR168 administered by intravenous (IV) infusion” NCT06249438 ↗ |