New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing im­mu­no­ther­apies based on gene-edited allo­geneic CAR T-cells (UCART), to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has lifted the clin­i­cal hold on the Phase 1 MELANI-01 trial eval­u­ating the UCARTCS1 prod­uct can­di­date for the treat­ment of patients with re­lapsed or re­frac­tory mul­ti­ple myeloma (MM).

Cellectis worked closely with the FDA over the past months, to address the agency’s re­quests, which in­clude ad­just­ments to the MELANI-01 clin­i­cal protocol de­signed to en­hance patient safety. …

New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited allo­geneic CAR T-cells (UCART), to­day an­nounced that the MELANI-01 trial has been placed on clin­i­cal hold by the U.S. Food and Drug Admin­istra­tion (FDA).

This clin­i­cal hold which im­pacts one of the three Cellectis prod­uct can­di­dates cur­rently in clin­i­cal stud­ies, was ini­ti­ated fol­low­ing the sub­mission of a safety report re­gard­ing one patient en­rolled in the MELANI-01 study at dose level two (DL2), with re­lapsed and re­frac­tory mul­ti­ple myeloma. This patient, …

Cellectis’ UCARTCS1 MELANI-01 Trial Commenced at MD Anderson Cancer Center

New York, NY (Press Release) – Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Euronext Growth: ALCLS; Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited off-the-shelf CAR T-cells (UCART), to­day an­nounced the Com­pany has dosed the first patient in its UCARTCS1 clin­i­cal trial, MELANI-01, the first allo­geneic off-the-shelf CAR-T prod­uct can­di­date the U.S. Food and Drug Admin­istra­tion (FDA) has cleared to enter into clin­i­cal devel­op­ment for re­lapsed / re­frac­tory mul­ti­ple myeloma (R/R MM). The UCARTCS1 clin­i­cal trial is a Phase 1 dose-escalation study to eval­u­ate the safety, ex­pan­sion, persistence and clin­i­cal ac­­tiv­ity of UCARTCS1 cells …

The U.S. Food and Drug Admin­istra­tion (FDA) has given the go-ahead for what is likely to be the first clin­i­cal trial of an allo­geneic chi­meric an­ti­gen re­cep­tor (CAR) T-cell ther­apy for mul­ti­ple myeloma.

The poten­tial new myeloma CAR T-cell ther­apy, known as UCARTCS1, is being devel­oped by the French bio­pharma­ceu­tical com­pany Cellectis. The com­pany an­nounced earlier this week that the FDA approved its Investi­ga­tional New Drug (IND) appli­ca­tion for UCARTCS1 in late Jan­u­ary.

The IND ap­prov­al means Cellectis can move for­ward with its plans for MUNDI-01, a Phase 1 dose escalation trial …

Successful manu­fac­tur­ing and re­lease of GMP vials of UCARTCS1

New York, NY (Press Release) – Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a bio­pharma­ceu­tical com­pany focused on devel­op­ing immuno­therapies based on gene-edited CAR T-cells (UCART), an­nounced to­day that the U.S. Food and Drug Admin­istra­tion (FDA) has approved the Com­pany’s Inves­ti­ga­tional New Drug (IND) appli­ca­tion to ini­ti­ate a Phase 1 clin­i­cal trial for UCARTCS1, in patients with mul­ti­ple myeloma (MM). The IND for UCARTCS1 was filed on De­cem­ber 28, 2018 and approved by the FDA within a month, on Jan­u­ary 25, 2019. Cellectis is the sponsor of the UCARTCS1 clin­i­cal study (MUNDI-01) and …