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May. 2023
Gracell Biotechnologies initiated investigational study evaluating GC012F for treatment of refractory Systemic Lupus Erythematosus (SLE), expanding clinical evaluation of FasTCAR-T GC012F into autoimmune disease
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Feb. 2023
China NMPA cleared IND application for Phase 1/2 clinical trial of FasTCAR-T GC012F for the treatment of r/r MM
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Jan. 2023
U.S. FDA cleared IND application for Phase 1b/2 clinical trial of FasTCAR-T GC012F for the treatment of r/r MM
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Dec. 2022
Gracell Biotechnologies presented first-in-human data on BCMA/CD19 dual-targeting FasTCAR-T GC012F for high risk, newly diagnosed multiple myeloma patients at ASH 2022, demonstrating 100% ORR and 100% MRD- rate
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Nov. 2022
Gracell Biotechnologies won 2022 Fierce Life Sciences Innovation Award
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Oct. 2022
Gracell Biotechnologies dosed first patient in phase 2 portion of registrational phase 1/2 clinical trial evaluating GC007g for the treatment of B-ALL
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Jun. 2022
Gracell Biotechnologies presented updated clinical data on BCMA/CD19 dual-targeting FasTCAR-T GC012F in r/r MM at EHA2022 Congress, highlighting 100% MRD- rate in all treated patients
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Feb. 2022
Gracell Biotechnologies dosed first patients in First-in-Human clinical trial evaluating GC012F, a dual-targeting FasTCAR-T Therapy for the treatment of B-Cell Non-Hodgkin's Lymphoma
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Dec. 2021
Gracell Biotechnologies was selected for addition to NASDAQ Biotechnology Index
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Nov. 2021
Gracell Biotechnologies was granted FDA Orphan Drug Designation for FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy candidate GC012F for the treatment of multiple myeloma
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Mar. 2021
Signs agreement with Lonza to manufacture Gracell's FasTCAR product candidates in the U.S.
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Jan. 2021
Completes IPO and NASDAQ listing, raising $240 million in gross proceeds
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Jan. 2021
NMPA approves IND for GC019F FasTCAR? enabled autologous CAR-T therapy for r/r adult B-ALL
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Jan. 2021
Suzhou manufacturing facility receives Medical Products Manufacturing Certificate from JSMPA
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Dec. 2020
NMPA approves registrational seamless Phase 1/2 clinical trial for GC007g donor-derived allogeneic CAR-T cell therapy for r/r B-ALL
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Dec. 2020
Reports first-in-human data at ASH 2020 on GC012F FasTCAR-enabled dual-targeting BCMA/CD19 cell therapy in patients with r/r MM
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Oct. 2020
Closes series C funding led by Wellington Management Company, OrbiMed, and Morningside Ventures, and participation from Vivo, Temasek, LAV, Kington Capital, and Chengdu Miaoji
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Aug. 2020
Suzhou GMP manufacturing facility opens
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Apr. 2020
NMPA approves IND application for GC007g donor-derived CAR-T cell therapy for CD19 positive r/r B-ALL
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Feb. 2019
Closes series B funding from Temasek, OrbiMed, Lilly Asia Ventures, Kington Capital, and Chengdu Miaoji
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Oct. 2017
Shanghai R&D facility opens
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May. 2017
Gracell Biotechnologies was founded by Dr. William Wei Cao and co-founding team