On July 6, 2020, the US Food and Drug Administration (FDA) issued a clinical hold for the phase 1 MELANI-01 trial (ClinicalTrials.gov Identifier: NCT04142619), a dose-escalation study evaluating an investigational universal chimeric antigen receptor (CAR) T-cell (CAR-T) product in patients with relapsed or refractory multiple myeloma.

Developed by Cellectis, the product is known as UCARTCS1A and consists of allogenic T-cells that are genetically engineered to express a CAR against CS1, also known as SLAMF7. CS1 is “highly” expressed in multiple myeloma, according to the company’s press release.

The trial was put on clinical hold after a safety report revealed that 1 trial participant died from cardiac arrest, which was deemed a treatment-emergent adverse event. The participant received dose level 2 of the investigational product and had prior treatment with “numerous lines” of therapy, including autologous CAR T cells.

“Clinical evaluation of the case remains ongoing and additional details as to the immediate and underlying causes of this event are being collected,” the press release stated.


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Cellectis is amending the MELANI-01 clinical protocol, among other requests by the FDA.

The clinical hold does not affect phase 1 dose-escalation trials AMELI-01 and BALLI-01, which are each evaluating different universal CAR-T products from Cellectis.

The AMELI-01 trial (ClinicalTrials.gov Identifier: NCT03190278) is evaluating a CAR-T product that targets CD123 in patients with relapsed and refractory acute myeloid leukemia, and the BALLI-01 trial (ClinicalTrials.gov Identifier: NCT04150497) is evaluating a CAR-T product that targets CD22 in patients with relapsed and refractory B-cell acute lymphoblastic leukemia.

Reference

Cellectis reports clinical hold placed on MELANI-01 study [news release]. New York, NY: Cellectis Inc.; July 6, 2020. Accessed July 11, 2020.

This article originally appeared on Cancer Therapy Advisor