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FDA Lifts Holds on "Off-the-Shelf" CAR-T Trials

Jason Harris
Published: Tuesday, Nov 07, 2017

The FDA today lifted clinical holds placed on 2 phase I trials investigating a gene-edited allogeneic CAR T-cell (UCART) therapy known as UCART123.

The company agreed to implement several provisions in the phase I UCART123 trials to lift the hold:
  • Decrease the cohort dose level to 6.25 x 104 UCART123 cells/kg
  • Decrease the lymphodepleting regimen of cyclophosphamide to 750 mg/m² over 3 days, with a maximum daily dose of 1.33 grams of cyclophosphamide
  • Include specific patient criteria at UCART123 infusion, such as no new uncontrolled infection after receipt of lymphodepletion, afebrile, only receiving a replacement dose of corticosteroids, and no organ dysfunction since eligibility screening
  • Ensure the next 3 patients to be treated in each protocol will be under the age of 65
  • Stagger enrollment across the UCART123 protocols AML123 and ABC123: at least 28 days should elapse between the enrollments of 2 patients across the 2 studies
Cellectis is working with investigators and clinical sites to obtain approval from its institutional review board on the revised protocols and resume patient enrollment.

Researchers observed antitumor activity in 2 of 6 of the relapsed patients during the period of CD19-CAR-T cell persistence, whereas 2 patients who received cells while in remission remained disease-free. Of these 2 patients, 1 remained in CR for more than 8 months and the other remained in CR for 8 weeks after CAR-T infusion.
Liu, Zhong JF, Zhang X, Zhang C. Allogeneic CD19-CAR-T cell infusion after allogeneic hematopoietic stem cell transplantation in B cell malignancies. J Hematol Oncol. 2017;10(1):35. doi: 10.1186/s13045-017-0405-3.

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