ASH 2020: The first human treatment data for the BCMA/CD19 dual-targeted CAR-T treatment of relapsed or difficult-to-treat multiple myeloma are amazing

On December 6th Gracell Biotechnology Inc., a global clinical-stage biopharmaceutical company dedicated to the development of efficient and cost-effective cell therapies for cancer, released the results of a phase 1 clinical trial initiated by researchers to assess the safety and effectiveness of its pioneering BCMA/CD19 dual-target CAR-T cell therapy GC012F treatment for relapsed or difficult-to-treat multiple myeloma (R/R MM) patients.
, director of hematology at Shanghai Long March Hospital, made the data in oral presentation at the 2020 annual meeting of the American Society of Hematology (ASH).
GC012F is a self-contained CAR-T cell therapy based on the FasTCAR platform technology unique to the next day's production, targeting BCMA/CD19 dual antigens.
the candidate has been evaluated in a phase I clinical trial initiated by researchers.
as of July 17, the three dosage groups in the study had a total of 16 patients, with a maximum dose level of 3×10 to 5 cells/kg.
the patient received a 30-minute GC012F single infusion three days after receiving the standard lymphatic removal program.
early total response rate (ORR) is as high as 93.7%, and all responses reach or exceed VGPR, demonstrating fast, deep, and long-lasting response characteristics.
6 patients treated at the highest dose level (n-6) all achieved MRD-negative sCR, and a six-month milestone analysis conducted at the data cut-off showed that 4 of them (n-4) remained IND-negative sCR.
the trial was 7.3 months (ranging from 1-10 months).
of the 16 patients treated, 93.7% were classified as high risk according to msMART 3.0 guidelines, 19% were double hit R/R MM, and 31% had myelitis.
patients with a medium previous treatment line of 5,75% were resistant to the previous treatment and 19% were primary refractory.
94% of patients had triple exposure to (triple exposure) PI, IMiD, and at least a third treatment, including anti-CD38 targeted therapy.
63% of patients had been exposed to at least five different treatments, including PI, IMiD and other treatments.
patient with myeloid lesions achieved a negative MRD result in the first bone marrow assessment in the first month, but was found to be unsys response due to the increasing number of myeloid lesions in the first month.
The safety of GC012F is controllable, the overall level of cytokine release syndrome (CRS) is low (87.5% of patients are 1/2, 2 patients are level 3, there are no level 4 or 5 events), and the medium duration is 4 days (range 1-8 days).
treatment for CRS, including tosilided monoantigens and steroids, and all cases were alleviated.
ICANS (immune effect cell-related neurotoxicity events) was not observed in 16 patients.
adverse events (TEAEs) that occur during treatment are mainly manifested in decreased blood cells and increased AST.
three patients had lower respiratory tract infections.
all TEAEs are relieved after standard treatment.
"We are encouraged by the fact that the vast majority of these 16 patients have high-risk characteristics, and we are encouraged by these early clinical findings," said Dr. Martina Sersch (MD, PhD), chief medical officer of Psychic Bio.
Patients treated with the highest dose level of GC012F, 100% of patients who received MRD-negative sCR within six months of infusion, indicating that patients who have received a large number of and multiple treatments in the past but have not responded successfully or are no longer responding to standard treatments are expected to benefit from the product.
is advancing the project's global development and looks forward to sharing the latest developments in the near future.
" about Grace Biotechnology Inc. is a global clinical phase biopharmaceutical company dedicated to the discovery and development of breakthrough cell therapies.
With its groundbreaking FasTCAR and TruUCAR technology platforms, the company is developing candidates for a wide range of autobiographical and allogeneic cells that may overcome industry challenges with traditional CAR-T therapies, including long manufacturing times, poor production quality, high treatment costs, and limited efficacy for solid tumors.
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