Cellectis submits IND to US FDA for ‘off-the-shelf’ UCART22

By Flora Southey

- Last updated on GMT

Cellectis has submitted an IND for off-the-shelf T-cell candidate UCART22, an allogeneic investigational therapy designed to treat leukemia.

The French biotech submitted the investigational new drug (IND) application to the US Food and Drug Administration (FDA) earlier this month, and if approved, will instigate a Phase I clinical trial in Q3 2018.

UCART22 is an allogeneic, gene-edited T-cell candidate designed to treat B-cell acute lymphoblastic leukemia (B-ALL) in adult patients.

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.

Cellectis​’ first allogeneic off-the-shelf CAR-T investigational therapy – UCART19​ – is still in clinical development.  

“In its design, UCART22 is quite similar to UCART19, that only by the target recognized by the CAR – CD22 in lieu of CD19,” ​a spokesperson explained.

“The UCART22 cells infused in patients are meant to recognise CD22-bearing tumour cells, expand and destroy the tumour mass in the body, leading to remission of the patient,” ​she added.

But anti-CD19 therapy trials have shown that ALL-patients may lose the CD19 antigen from their tumour cells, hence the need for a second target – CD22, we were told.

Cellectis has selected MD Anderson in Houston, Texas, to conduct clinical trials and CELLforCURE to manufacture its product candidates.  

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