Drugs / GC012F
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 011 trials | ||||||
| Phase 0 | NCT07315503 | Dec 2027 → Jan 2028 | rheumatoid arthritis | Institute of Hematology & Blood Diseases Hospital, China | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT07303790 | Mar 2026 → Jan 2027 expected | multiple sclerosis | Daishi Tian | Recruiting | No outcome recorded |
| Phase 0 | NCT07364487 | Jan → Mar 2026 | multiple sclerosis | Huashan Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT07086404 | Sep 2025 → Sep 2027 expected | idiopathic inflammatory myopathy | Daishi Tian | Recruiting | No outcome recorded |
| Phase 0 | NCT07072884 | Aug 2025 → Mar 2027 expected | idiopathic inflammatory myopathy, systemic sclerosis | Qiong Fu | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT07058298 | Jul 2025 → Feb 2027 expected | generalized myasthenia gravis | Daishi Tian | Recruiting | No outcome recorded |
| Phase 0 | NCT06419166 | Dec 2024 → Jun 2027 | generalized myasthenia gravis | Zhejiang University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT05858684 | May 2023 → Aug 2028 expected | — | RenJi Hospital | Recruiting | No outcome recorded |
| Phase 0 | NCT05840107 | May 2023 → Sep 2025 | plasma cell myeloma | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT04617704 | Dec 2021 | plasma cell myeloma | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT04236011 | Jan 2020 → Jul 2022 | plasma cell myeloma | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT07250269 | Oct 2025 → Nov 2028 expected | AL amyloidosis | Gracell Biotechnologies (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1 | NCT06759948 | Feb 2025 → Feb 2027 expected | generalized myasthenia gravis | Chongbo Zhao | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05846347 | May → Oct 2023 | — | Zhejiang University | Unknown | No outcome recorded |
| Phase 1 | NCT05412329 | Jun 2022 → Jun 2024 | plasma cell myeloma | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06235229 | Dec 2023 → Mar 2026 overdue | plasma cell myeloma | Gracell Biotechnologies (Shanghai) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04935580 | Jun 2021 → Jul 2023 | plasma cell myeloma | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2024-11-07 | AstraZeneca | Results AstraZeneca showcases strength of haematology portfolio and pipeline at ASH 2024 astrazeneca.com ↗
Preliminary results from the ongoing investigator-initiated trial of AZD0120 suggest deep responses and an acceptable safety profile, with no ICANS and no ≥Grade 2 CRS events observed in this patient population. |
| 2024-06-16 | AstraZeneca | Results Calquence plus chemoimmunotherapy reduced the risk of disease progression or death by 27% vs. standard of care in patients with untreated mantle cell lymphoma in ECHO Phase III trial astrazeneca.com ↗
Early results showed that GC012F had an overall response rate of 100%, a minimal residual disease-negative stringent complete response rate of 95%, and was well tolerated. |
| 2024-01-29 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Regulatory Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1 Clinical Trial of FasTCAR-T GC012F as Early-Line Treatment of Multiple Myeloma gracellbio.com ↗
Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug (IND) application, allowing the Company to initiate a Phase 1 clinical trial of GC012F in the United States for the early-line treatment of multiple myeloma (ELMM). |
| 2023-12-21 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Regulatory Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus gracellbio.com ↗ |
| 2023-12-11 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023 gracellbio.com ↗
GC012F demonstrated a 100% overall response rate (ORR) and 95% MRD- sCR rate among 22 transplant-eligible, high-risk NDMM patients as of the data cutoff date of October 1, 2023. |
| 2023-11-27 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Regulatory Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Refractory Systemic Lupus Erythematosus gracellbio.com ↗
Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug (IND) application, allowing the Company to initiate a Phase 1/2 clinical trial of FasTCAR-T GC012F in the United States for the treatment of refractory systemic lupus erythematosus (rSLE). |
| 2023-11-02 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies to Present Updated Results from BCMA/CD19 Dual-Targeting FasTCAR-T GC012F in Newly Diagnosed Multiple Myeloma at the 65ᵗʰ American Society of Hematology Annual Meeting & Exposition gracellbio.com ↗
With additional patients enrolled and longer follow-up, we are encouraged to report that FasTCAR-T GC012F has continued to demonstrate impressive depth of responses and a highly favorable safety profile. |
| 2023-09-27 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies Reports Updated Clinical Data for FasTCAR-T GC012F for High-Risk, Newly Diagnosed Multiple Myeloma, Demonstrating 100% Stringent Complete Response Rate gracellbio.com ↗
GC012F demonstrated a 100% overall response rate (ORR) and a 100% MRD- sCR rate among 19 transplant-eligible, high-risk NDMM patients as of the data cutoff date of August 1, 2023. |
| 2023-06-10 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies Presents Longer-Term Results for FasTCAR-T GC012F in B-Cell Non-Hodgkin’s Lymphoma at EHA2023, Highlighting 100% Overall Response Rate gracellbio.com ↗
Data on CD19/BCMA dual-targeting FasTCAR-T GC012F showed 100% overall response rate (ORR) and 66.7% 6-month complete response (CR) rate among treated patients, all with diffuse large B-cell lymphoma (DLBCL) subtype |
| 2023-06-03 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies Presents Updated Data of Deep and Durable Responses for FasTCAR-T GC012F in Relapsed/Refractory Multiple Myeloma at 2023 ASCO Annual Meeting gracellbio.com ↗
Data on BCMA/CD19 dual-targeting FasTCAR-T GC012F showed 100% minimal residual disease (MRD) negativity and 82.8% MRD negative stringent complete response (sCR) in a predominantly high-risk relapsed/refractory multiple myeloma (RRMM) population |
| 2023-02-13 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Regulatory Gracell Biotechnologies Announces China NMPA Clearance for IND Application for Phase 1/2 Clinical Trial of FasTCAR-T GC012F for Treatment of Relapsed/Refractory Multiple Myeloma gracellbio.com ↗ |
| 2023-02-03 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Regulatory Gracell Biotechnologies Announces FDA Clearance of the IND Application for Phase 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Relapsed/Refractory Multiple Myeloma gracellbio.com ↗ |
| 2022-12-10 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies Presents Clinical Data for FasTCAR-T GC012F for High Risk, Newly Diagnosed Multiple Myeloma Demonstrating 100% Overall Response Rate gracellbio.com ↗
Patients in the study achieved a 100% overall response rate (ORR) and 100% minimal residual disease (MRD) negativity in all dose levels. |
| 2022-11-03 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies to Present First Clinical Data of FasTCAR-T GC012F for Newly Diagnosed Multiple Myeloma at 64th American Society of Hematology Annual Meeting & Exposition gracellbio.com ↗
BCMA/CD19 dual-targeting FasTCAR-T GC012F demonstrated 100% ORR and 100% MRD negativity in the 13 patients treated |
| 2022-06-12 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies Presents Updated Clinical Data for BCMA/CD19 Dual-targeting FasTCAR GC012F in RRMM at EHA2022 Congress, Highlighting 100% MRD Negativity Rate in All Treated Patients gracellbio.com ↗
GC012F for the treatment of RRMM continues to demonstrate a favorable safety profile and a promising mDOR of 15.7 months in mostly high risk, heavily pretreated patients, including those with extramedullary disease and those who were previously exposed to PI, IMiDs and anti-CD38 agents. |
| 2022-05-12 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies to Present Clinical Data on BCMA/CD19 Dual-targeting CAR-T GC012F in RRMM and B-NHL and CD19/CD7 Dual-directed Allogeneic CAR-T GC502 in B-ALL at EHA2022 Congress gracellbio.com ↗
The clinical data of BCMA/CD19 dual-targeting GC012F in the treatment of B-NHL shows promising early results, along with benefits of the next-day manufacturing enabled by the FasTCAR platform. |
| 2021-11-19 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Regulatory Gracell Biotechnologies Granted FDA Orphan Drug Designation for FasTCAR-enabled BCMA/CD19 Dual-targeting CAR-T Cell Therapy Candidate GC012F for the Treatment of Multiple Myeloma gracellbio.com ↗
We are very excited about being granted Orphan Drug Designation for the treatment of Multiple Myeloma by the U.S. FDA, another key milestone in advancing our program globally. |
| 2021-05-19 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies to Present Updated Results of GC012F FasTCAR-enabled BCMA/CD19 Dual-targeting CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma at ASCO 2021 and EHA 2021 gracellbio.com ↗
Early Overall Response Rate (ORR) shows a promising 94.7% (18/19) with all responses being VGPR or better (sCR), demonstrating fast, deep and durable responses in all dose levels. |
| 2020-12-05 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Biotechnologies Announces Presentation of First-in-Human Data of GC012F a First-in-Class FasTCAR-enabled Dual-targeting BCMA/CD19 CAR-T Cell Therapy for Patients with Relapsed or Refractory Multiple Myeloma at 2020 ASH Annual Meeting gracellbio.com ↗
100% of the patients treated at the highest dose level (n=6) obtained a MRD negative sCR which was maintained through the landmark analysis of six months (n=4) at the time of data cut off |
| 2019-12-09 | Gracell Biotechnologies (Shanghai) Co., Ltd. | Results Gracell Announces Progressive Outcomes from Multiple Human Clinical Trials to Investigate FasTCAR and Dual CAR Cell Platform Technologies gracellbio.com ↗
15 of 16 (93.8%) in mid and high dose groups achieved complete remission, and confirmed with MRD-CR, with or without complete blood count recovery (CR/CRi) on Day 28. |
All press releases naming this drug 28 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GC012F | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05840107 ↗ |
| Known as | AZD0120 | “GC012F, now renamed AZD0120, is an autologous B-cell maturation antigen and CD19 dual-targeting chimeric antigen receptor (CAR) T-cell product manufactured on the FasTCAR platform.” PMID 41925575 ↗ Jun 2026 |
| Known as | CD19-BCMA CAR-T cells | “GC012F injection (CD19-BCMA CAR-T cells)” NCT05846347 ↗1“Other Name: CD19-BCMA CAR-T cells” NCT06419166 ↗ |
| Known as | GC012F injection | “GC012F injection is an autologous dual CAR-T targeted BCMA and CD19.” NCT04935580 ↗1“Drug: GC012F injection” NCT06759948 ↗ |
| Action | Deplete | “CD19- BCMA CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells” NCT05858684 ↗ |
| Modality | Cell therapy | “autologous dual chimeric antigen receptor T-cell (CAR-T) therapy” NCT04236011 ↗ |
| Route | Intravenous | “administered intravenously” NCT04236011 ↗ |
| Target | CD19 | “GC012F is an autologous dual chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) and CD19.” NCT04236011 ↗ |