IND Cleared for Dual-Targeted CAR T Therapy for B-Cell Malignancies

Cellectis has received investigational new drug (IND) clearance for their dual-targeted allogeneic chimeric antigen receptor (CAR) T-cell therapy UCART2022 for the potential treatment of B-cell malignancies.

“We are delighted that the FDA has cleared our IND application for UCART2022,” André Choulika, PhD, chief executive officer, Cellectis, said in a statement. “This is a very exciting product candidate, for two reasons: UCART2022 will be our first dual allogeneic CAR T product candidate to enter clinical development, and dual targeting of CD20 and CD22, both validated targets in B-cell malignancies, has the potential to enhance tumor cell killing and increases the breadth of antigen targeting. These advantages may increase the addressable patient population and represent a potential therapeutic alternative to CD19-directed therapies.

Cellectis expects to begin enrolling patients in their phase 1/2a NatHaLi-01 clinical trial in the second half of 2022. The first part of the study will be a dose-finding portion that will evaluate the therapy in a broad range of mature B-cell non-Hodgkin lymphomas (NHLs).

UCART2022 uses the Cellectis’ TALEN platform to mediate disruptions of the TRAC gene, to reduce the risk of graft-versus-host disease, and of the CD52 gene, which allows use of a CD52-directed monoclonal antibody in preconditioning regimens and enhances engraftment, expansion and persistence of CAR T cells. The TALEN platform uses TAL nucleases to edit genes with high specificity.

READ MORE: Gamma Delta CAR T-Cell Therapy Shows Promising Responses in B-Cell Malignancies

“UCART2022 is also our first product candidate with fully integrated in-house development, showcasing our transformation into an end-to-end cell and gene therapy company, from discovery, process development, and GMP manufacturing to clinical development. We are very excited to start the clinical trial for patients with relapsed or refractory Non-Hodgkin Lymphoma,” Choulika added.

CGTLive previously spoke to Choulikaabout the company’s current focus on hematologic malignancies and expansion into solid tumors. He discussed Cellectis’ lead programs, including UCART22, UCART123 for the potential treatment of relapsed or refractory acute myeloid leukemia, and UCARTCS1 for the potential treatment of relapsed or refractory multiple myeloma.

"CD19 is an overcrowded target. So, we have an alternative target, CD22, and this CAR is currently being developed for acute lymphoblastic leukemia. We provided data last year at ASH and will provide some updates on this trial soon, so it's a very exciting CAR. It's a huge unmet medical need because a lot of people that relapse CD19 negative or after CD19 treatment then have no options,” Choulika commented on UCART22 to CGTLive.

Watch part of Choulika’s interview with CGTLive below.

REFERENCE

Cellectis receives IND clearance for UCART20x22, its first in-house manufactured product candidate for the treatment of B-cell malignancies. News release. Cellectis. August 1, 2022. https://www.globenewswire.com/news-release/2022/08/01/2489902/0/en/Cellectis-Receives-IND-clearance-for-UCART20x22-its-First-in-house-Manufactured-Product-Candidate-for-the-Treatment-of-B-cell-Malignancies.html