Shanghai based-biotech company CARsgen Therapeutics has announced that its CAR T cell candidate CT071 has shown early signs of efficacy in an ongoing Phase I trial in relapsed and refractory multiple myeloma (RRMM).
CT071 is CAR T cell drug that acts by binding to cells expressing GPRC5D. It was developed using CARsgen’s CARcelerate platform for the treatment of patients with RRMM or plasma cell leukaemia.
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Preliminary data from the Phase I trial (NCT05838131) was shared during the 29th Annual Congress of the EHA, which took place in Madrid, Spain on 13–16 June.
The first in human study is a single-arm, open-label trial with a primary endpoint of safety and tolerability. The trial is also investigating dose range and early signs of efficacy.
Investigators had dosed ten patients as of the 28 February data cut off, seven at a low dose and three at high dose. The overall response rate (ORR) was 90%. Five patients showed stringent complete response, two had very good partial response and two had partial response.
Pharmacokinetic analysis showed robust cell expansion and persistence after dosing.
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By GlobalDataAs of the data cut-off, CARsgen observed no Grade 3 adverse events. There were also no events of dose limiting toxicity.
CARsgen chief medical officer Raffaele Baffa said: “The preliminary results of the ongoing study presented at EHA shows that CT071 has the potential to be the best-in-class GPRC5D targeting CAR-T therapy.”
T cell therapy accounts for 55% of all adoptive cell therapy trials, according to data obtained from GlobalData’s Trials Intelligence platform.
CARsgen currently has 16 drug candidates in active stages of development, as per GlobalData’s Pipeline Drugs database.
GlobalData is the parent company of the Clinical Trials Arena.
MM is a form of blood cancer that affects plasma calls in the bone marrow.
Pfizer this month announced findings from the Phase II MagnetisMM-3 clinical trial of ELREXFIO (elranatamab-bcmm) in patients with RRMM. The trial showcased an ORR of 61% and a complete response rate of 37.4%, with a median duration of response not yet reached. At the two-year mark, the estimated duration of response rate stood at 66.9% for all responders, and 87.9% for those with a complete response or better.
The US Food and Drug Administration is currently investigating reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.
The agency said it had determined that the risk of T-cell malignancies was applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies.
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