Drugs / OriCAR-017
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial · 1 met primary | ||||||
| Phase 0 | NCT05016778 | Jun 2021 → Jun 2024 | plasma cell myeloma | Zhejiang University | Unknown | Met primary |
| Phase 11 trial | ||||||
| Phase 1 | NCT06271252 | Apr 2024 → Dec 2026 expected | immunoproliferative disorder, lymphoproliferative syndrome, monoclonal paraproteinemia disease, plasma cell myeloma +1 | OriCell Therapeutics Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06182696 | Oct 2023 → Nov 2026 expected | refractory plasma cell neoplasm | OriCell Therapeutics Co., Ltd. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-07-15 | OriCell Therapeutics Co., Ltd. | Regulatory Oricell Therapeutics’ GPRC5D-Targeted CAR-T Therapy, OriCAR-017, Receives FDA Fast Track Designation for Relapsed/Refractory Multiple Myeloma oricell.com ↗
Oricell Therapeutics, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation (FTD) for OriCAR-017, a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). |
| 2024-06-05 | OriCell Therapeutics Co., Ltd. | Results Oricell Presented Long-term Follow-up Data of OriCAR-017 in RRMM at 2024 ASCO Annual Meeting, Highlighting the Sustained Efficacy of GPRC5D CAR-T Therapy oricell.com ↗
Oricell Therapeutics, a pioneering clinical-stage biopharmaceutical company, has presented the two-year long-term follow-up results of OriCAR-017, an open-label Phase I study evaluating GPRC5D-targeted CAR-T therapy in patients with relapsed/refractory multiple myeloma (RRMM), in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. |
| 2024-05-24 | OriCell Therapeutics Co., Ltd. | Results Oricell to Present OriCAR-017 Data at 2024 ASCO Annual Meeting: Oral presentation of long-term follow-up data of GPRC5D CAR-T in RRMM oricell.com ↗
The updated data demonstrates that OriCAR-017 elicits deep and durable responses in RRMM patients as well as a favorable safety profile, including those refractory to anti-CD38 therapies, PIs, IMIDs, and those who have failed BCMA targeting CAR-T treatment. |
| 2024-05-16 | OriCell Therapeutics Co., Ltd. | Results Oricell Therapeutics Announces Oral Presentation of OriCAR-017 Long-Term Follow-Up Data at the ASCO 2024 Annual Meeting oricell.com ↗
The latest data showed that all ten patients with R/R MM responded to the therapy per IMWG criteria, achieving a 100% overall response rate (ORR), 80% stringent complete response. |
| 2024-01-29 | OriCell Therapeutics Co., Ltd. | Regulatory Oricell Announces FDA Clearance of IND Application for OriCAR-017, a novel GPRC5D Targeted CAR-T Cell Therapy Utilizing the Company’s Proprietary Platform, for the Treatment of Relapsed/Refractory Multiple Myeloma oricell.com ↗
Oricell Therapeutics (Oricell), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for OriCAR-017 for patients with relapsed/refractory multiple myeloma (R/R MM). |
| 2023-12-29 | OriCell Therapeutics Co., Ltd. | Regulatory Oricell filed OriCAR-017 IND to the FDA today oricell.com ↗
We are excited to announce that we have filed IND application of OriCAR-017 to the FDA on this day. |
| 2023-08-10 | OriCell Therapeutics Co., Ltd. | Regulatory Oricell OriCAR-017 CAR-T Therapy Clears IND Hurdle, Paving the Way for Global Impact oricell.com ↗
Oricell Therapeutics Co., Ltd. ("Oricell") has received the green light for its Investigational New Drug (IND) application of OriCAR-017 |
| 2023-01-31 | OriCell Therapeutics Co., Ltd. | Results Oricell Publishes Data from POLARIS Clinical Study Evaluating OriCAR-017 in the Treatment of RRMM in oricell.com ↗
Oricell releases the latest clinical data in The LANCET Haematology. |
| 2022-10-26 | OriCell Therapeutics Co., Ltd. | Regulatory Oricell's GPRC5D CAR-T receives Orphan Drug Designation from FDA oricell.com ↗
the United States (U.S) Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation (ODD) to Oricell's proprietary CAR-T cell therapy targeting GPRC5D (OriCar-017) for the treatment of Relapsed/Refractory Multiple Myeloma (R/R MM). |
| 2022-06-10 | OriCell Therapeutics Co., Ltd. | Results OriCell Reports OriCAR-017 Phase I POLARIS study Data in Oral Presentation at ASCO 2022 oricell.com ↗
Overall Response Rate(ORR) was 100% with Complete Response (CR)/ stringent Complete Response (sCR) rate of 60%，including Five patients with prior BCMA CART therapy achieved 2 sCR, 2 VGPR and 1PR. |
| 2022-05-27 | OriCell Therapeutics Co., Ltd. | Results OriCell Releases Full Abstract of its 2022 ASCO Oral Report oricell.com ↗
Responses were durable and deepened overtime with 100% ORR and 100% MRD negative rate, including BCMA CAR-T relapsed patients, all patients are progression free and followed without additional therapy at the cutoff date. |
All press releases naming this drug 12 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OriCAR-017 | “GPRC5D CAR T cells (OriCAR-017) in patients with relapsed or refractory multiple myeloma (POLARIS): a first-in-human, single-centre, single-arm, phase 1 trial.” PMID 36725117 ↗ Feb 2023 |
| Modality | Cell therapy | “chimeric antigen receptor modified T cells” NCT06182696 ↗ |
| Route | Intravenous | “single dose of intravenous OriCAR-017” PMID 36725117 ↗ Feb 2023 |
| Target | GPRC5D | “GPRC5D directed” NCT06182696 ↗ |