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UCART22 is intended for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. Credit: Animalculist/commons.wikimedia.org.

Cellectis has dosed the first patient in France in the BALLI-01 clinical study of UCART22 for the treatment of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).

The company’s in-house manufactured product, UCART22 is an allogeneic CAR T-cell product candidate that targets CD22.

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Designed to evaluate the safety and clinical activity, BALLI-01 is a Phase I/IIa open-label clinical study enrolling patients with r/r B-cell ALL after fludarabine, cyclophosphamide and alemtuzumab (FCA) lymphodepletion.

Cellectis chief medical officer Mark Frattini said: “Our team has worked tirelessly to expand our BALLI-01 clinical study (evaluating UCART22) to Europe.

“Dosing our first patient in France with our UCART22 product candidate manufactured in-house is an important advancement for Cellectis.

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“By targeting the CD22 antigen, we aim at offering a novel therapeutic alternative to patients living with relapsed/refractory B-cell ALL, including those patients who have relapsed or did not respond to CD19-directed therapy.”

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Through its proprietary GMP manufacturing units, the company has started production of UCART in both Raleigh, North Carolina and Paris, France.

In addition, the company’s in-house manufacturing unit maximises the chances for eligible patients to be treated without delay.

The company said that its first France patient in the BALLI-01 trial was dosed with UCART22 in the 28-day dose limiting toxicity period. Using its gene editing technology, TALEN, and electroporation system, PulseAgile, Cellectis is developing new products to boost immunity and treat diseases with unmet medical needs.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva. 

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