CARsgen Therapeutics Holdings Limited (2171.HK), Wednesday announced that the results of the CT071 for the treatment of relapsed/refractory multiple myeloma in an investigator-initiated study with Government ID NCT05838131 have been published in The Lancet Haematology.
It is published under the title "GPRC5D-targeted CAR T-cell therapy (CT071) in patients with relapsed or refractory multiple myeloma: a first-in-human, single-centre, single-arm, phase 1 trial.
CT071 is a CAR T-cell therapy candidate developed utilising the proprietary CARcelerate platform targeting GPRC5D for the treatment of relapsed/refractory multiple myeloma R/R MM or plasma cell leukaemia, also known as PCL.
CT071 is an autologous CAR T-cell product targeting GPRC5D for the treatment of R/R MM, which is relapsed/refractory multiple myeloma.
The NCT05838131 trial is a single-arm, open-label, dose-finding, first-in-human clinical trial to preliminarily evaluate the safety and tolerability of CT071 after infusion, and explore the dose range of CT071 in patients with relapsed/refractory multiple myeloma or primary plasma cell leukaemia to determine the possible recommended therapeutic dose.
Twenty patients received CT071 infusion, who had received an average of 5 prior lines of therapy, of which 19 were double-class refractory, meaning their disease did not respond to two types of key drug classes used in myeloma.
The group had a disease that was resistant to many previous therapies; 13 were triple-class refractory, five were penta-drug refractory, 10 had received autologous stem cell transplantation, and five had relapsed after CAR T-cell. Four patients had extramedullary disease, 14 had high-risk cytogenetics greater than 1, and 19 had a Revised International Staging System 2 or 3 disease at baseline. Recommended phase 2 dose was determined at 0.1×106 CAR T cells/kg.
During the trial, no dose-limiting toxicities and no treatment-related deaths were observed. Cytokine release syndrome occurred in 12 patients (60%), all graded as 1 or 2. One patient experienced Grade 3 immune effector cell-associated neurotoxicity syndrome.
After an average follow-up of 10.71 months, the objective response rate was 100%, with a 95% confidence interval or CI on the response range of 83.2% to 100%.
In 18 of 20 patients, or 90%, minimal residual disease or MRD was not detectable at a level of 1 in 10^6 cells, including all patients who achieved a complete response/stringent complete response.
It is to be noted that, post the data cut off on December 9,2024, Median duration of response , progression-free survival and overall survival were not reached.
On the Hong Kong Stock Exchange, the shares had closed 5.51% lower at 20.60 HK$.
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