May 23, 2018 / 6:16 AM / 6 months ago

BRIEF-Cellectis Announces Approval Of Amendment To Protocol For UCART123 Phase 1 Clinical Trial

May 23 (Reuters) - CELLECTIS SA:

* ANNOUNCED ON TUESDAY APPROVAL OF AMENDMENT TO PROTOCOL FOR PHASE 1 CLINICAL TRIAL OF UCART123 PRODUCT CANDIDATE IN ACUTE MYELOID LEUKEMIA (AML) PATIENTS

* DOSE LEVEL 1 TO BE ADMINISTERED INCREASES FROM 6.25X104 TO 2.5X105 UCART123 CELLS PER KILOGRAM

* DOSE LIMITING TOXICITIES (DLT) OBSERVATION PERIOD DECREASES FROM 42 TO 28 DAYS POST-UCART123 INFUSION, EXCEPT FOR PATIENTS WITH APLASTIC BONE MARROW AT DAY 28

* FOR PATIENTS WITH APLASTIC BONE MARROW AT DAY 28, DLT OBSERVATION PERIOD REMAINS 42 DAYS

* TIME INTERVAL BETWEEN FIRST AND SECOND PATIENT FOR UCART123 INFUSION AT EACH NEW DOSE LEVEL SHORTENS FROM 42 DAYS TO 28 DAYS (42 DAYS FOR APLASTIC ANEMIA), THEN TO 14 DAYS FOR SUBSEQUENT PATIENTS

* POTENTIAL SECOND UCART123 INFUSION IS IMPLEMENTED

* NEW AML CLINICAL CENTER OPENS AT MD ANDERSON CANCER CENTER IN HOUSTON, TEXAS, TO INCREASE PATIENT ENROLLMENT PACE

* THE FDA REVIEW PERIOD FOR THIS PROTOCOL AMENDMENT HAS PASSED AND CELLECTIS OBTAINED IRB’S APPROVAL

Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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