US FDA approves Cellectis’ third ‘off-the-shelf’ CAR T-cell candidate for clinical trials

By Staff Reporter

- Last updated on GMT

(Image: Getty/7activestudio)
(Image: Getty/7activestudio)
Cellectis’ third gene-edited, ‘off-the-shelf’ CAR T-cell candidate is set to enter clinical development after the US FDA approved an IND application for UCART22.

The US Food and Drug Administration (FDA) has approved Cellectis’ investigational new drug (IND) application for allogeneic, chimeric antigen receptor (CAR) T-cell product candidate UCART22.

Unlike autologous therapies, which use a patient’s own engineered T-cells, this “off-the-shelf” ​investigational therapy uses engineered cells from a healthy donor for use in multiple patients.

The French biotech submitted the IND last month​ for UCART22, which is designed to treat adult patients with B-cell acute lymphoblastic leukemia (B-ALL).

“With this opportunity, Cellectis is well-positioned to further its work in the off-the-shelf gene-editing space, in the hope of helping patients to beat B-ALL in the near future,”​ said chief medical officer Stéphane Depil in a statement​.

UCART22 is the Cellectis’ third off-the-shelf CAR T-cell product candidate to receive FDA approval for clinical trials, after UCART19​ and UCART123​.

Cellectis expects to instigate a Phase I clinical study in the second half of the year at the University of Texas MD Anderson Cancer Center.

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