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.
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.
“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.”
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.
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