A patient's death occurs! Clinical trials for generic CAR-T treatment sympons for MM have been halted by the FDA.

Cellectis is a biopharmaceutical company focused on developing gene-editing-based allogeneic CAR-T cell (UCART) immunotherapy.
recently, the company announced that its clinical trial MELANI-01 has been suspended by the U.S. FDA.
the company's shares fell 18 percent on the news.
this clinical suspension affects one of the three allogeneic CAR-T cell therapys currently in clinical studies, UCARTCS1A, which is used to treat blood malignancies expressed as CS1/SLAMF7, due to the death of a patient with recurrent or refractive multiple myeloma (MM) treatment.
the patient, who had previously received multiple treatments and failed treatment, died of treatment-related cardiac arrest after receiving a level 2 dose (DL2) of UCARTCS1A, according to a statement from the company.
the ongoing clinical evaluation of the case is ongoing and more details on the immediate and potential causes of the incident are being collected.
note, Cellectis has decided to expand the number of patients enrolled in a level 1 dose (DL1) before the FDA issues a clinical suspension of patient death.
said in a statement that based on preliminary clinical and conversion data, DL1 may be suitable for further evaluation in the trial extension and may be the recommended dose of Phase II.
in addition, the company has begun to monitor and mitigate additional potential risks due to The Innovative Mechanism of UCARTCS1A.
currently, Cellectis is working closely with the FDA to meet safety requirements, including modifying the MELANI-01 clinical program to ensure future safety, and hopes to submit the requested information, including the revised plan, in due course.
in fact, this isn't the first time Cellectis has been hit by an FDA clinical suspension.
a clinical study of UCART123 was halted in the fall of 2017 due to the death of a patient.
months later, the study was restarted after a modification of the trial program covering acute myeloid leukemia (AML) and mother-cell plasma-like dendritic cell tumors (BPDCN).
in addition to UCARTCS1A and UCART123, the company also has an allogeneic CAR-T cell therapy UCART22, currently in Phase I dose-increasing research for the treatment of recurrent and refractable B-cell acute lymphoblastic leukemia (B-ALL).
has been on high alert for the safety of all-alike therapies entering clinical studies.
May 13 this year, Allogenes released the first data from its allogeneic ALLo-T treatment ALLO-501 treatment for recurrent/difficult non-Hodgkin lymphoma (NHL) first human study alpha, in addition to high efficacy (ORR s 78%; 9 assessable patients, 7 cases of remission, 3 cases of complete remission), and more importantly, ALLO-501.
Although 2 of the 11 patients treated with cytokine release syndrome (CRS) and 1 neurotoxicity occurred, none of them needed treatment to alleviate the elimination.
report: "Allogeneic" CAR-T therapy shows the safety data on the early efficacy of lymphoma treatment ALLO-501, to some extent dispelling investor concerns, and Allogene's share price climbed as soon as the data were released.
but analysts caution that the number of patients involved is small and needs to be closely watched as the number of patients expands.
Source: 1, Cellectis Reports Clinical Hold Hold Place on MELANI-01 Study 2, Cellectis slammed dweud patient dies and FDA s a hold on theirs for a for an off-the-shelf-shelf-t for multiplelemer.