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Pharmaceutical company Cellectis announced today that the FDA has suspended melani-01 Phase I clinical trials designed to assess the effectiveness and safety of CAR-T therapy UCTCS1 in the treatment of recurring multiple myeloma (MM).
the FDA ordered a moratorium in July after a patient experienced a fatal emergency cardiac arrest in the study.
, the company noted that patients treated with the second dose of UCARTCS1 were not treated with a variety of treatments, including innard CAR-T cells, before entering the group.
Cellectis also said that before the FDA announced the clinical reservation, the company had decided to expand the number of registrars for the first dose level and recommended that the recommended dose for Phase II clinical be determined based on preliminary clinical data.
"Cellectis has been working with the FDA over the past few months to address the agency's requirements, including making adjustments to the MELANI-01 research program to improve safety," said Carrie Brownstein, chief medical officer at Cellectis.
we remain confident in the potential clinical benefits of UCATCS1."
UCARTCS1 is designed to treat blood system malignancies that express CS1 / SLAMF7.
same time, the company said it is conducting clinical trials of two other CAR-T therapies, including UCT123 for relapsed acute myeloid leukemia and UCART22 for recurring recurring recurring recurring hard-to-treat B-cell acute lymphoblastic leukemia.
