Cellectis Announces Poster Presentation on BALLI-01 at the European Hematology Association (EHA) 2023
Published on May 11, 2023
BALLI-01 (evaluating UCART22) abstract demonstrates safety and preliminary efficacy of UCART22 in heavily pretreated r/r B-ALL population
New York, NY – May 11, 2023 - Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced the release of an abstract, which was accepted for presentation at the European Hematology Association (EHA) Hybrid Congress, taking place on June 8-15, 2023 in Frankfurt, Germany.
Cellectis will present, in a poster session, updated clinical and translational data on its BALLI-01 clinical trial (evaluating UCART22) in patients with relapsed/refractory B-cell acute lymphoblastic Leukemia (r/r B-ALL).
“Cellectis is excited to present updated clinical and translational data from its BALLI-01 clinical trial (evaluating UCART22) in patients with relapsed/refractory B-cell acute lymphoblastic leukemia. These data are very encouraging for patients who have limited, if any, treatment options, especially for those who have failed prior CD19 directed CAR T-cell therapy and allogeneic stem cell transplant” said Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis.
BALLI-01 investigation UCART22 product candidate in r/r B-ALL
The abstract includes preliminary clinical data from the Phase 1/2a, open label dose-escalation BALLI-01, in patients with r/r B-ALL having received UCART22 following lymphodepletion (LD) with either fludarabine, cyclophosphamide (FC) or FC with alemtuzumab (FCA).
The data show that UCART22 was well tolerated and clinical responses were achieved. UCART22 continues to have a good safety profile, with no serious treatment emergent adverse events (TEAEs) or DLTs reported. Overall, these data support the safety and preliminary efficacy of UCART22 in a heavily pretreated r/r B-ALL population.
UCART22 is a genetically modified allogeneic T-cell product manufactured from healthy donor cells. Donor-derived T-cells are transduced using a lentiviral vector to express the anti-CD22 chimeric antigen receptor (CAR) and are further modified using Cellectis’ TALEN® technology to disrupt the T-cell receptor alpha constant (TRAC) and CD52 genes to minimize risk of graft-vs-host disease (GvHD) and allow use of an anti-CD52 antibody for lymphodepletion (LD).
Title: Updated Results of the Phase I BALLI-01 Trial of UCART22, an Anti-CD22 Allogeneic CAR-T Cell Product, in Patients with Relapsed or Refractory (R/R) CD22+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Presenter: Nicolas Boissel, M.D., Ph.D., Hôpital St Louis, Assistance Publique – Hôpitaux de Paris, Paris, France
A copy of the abstract is available on the EHA website: https://library.ehaweb.org/eha/2023/eha2023-congress/385856/nicolas.boissel.updated.results.of.the.phase.i.balli-01.trial.of.ucart22.an.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Ac_id%3D385856