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- Cellectis’ proprietary product candidate, UCART22, used fludarabine, cyclophosphamide, and Alemtuzumab (FCA) for post-lymphatic administration in the BALLI-01 Phase 1 study with no dose-limiting toxicity
- Adding alemtuzumab to FC (FCA) leads to prolonged suppression of host lymphocytes and expansion of UCART22
- Preliminary data was observed in 2 patients showing encouraging anti-leukemia activity
- BALLI-01 is currently receiving the third dose level of the FCA (fludarabine, cyclophosphamide, alemtuzumab) lymphatic removal program
- Preclinical data of Cellectis’ proprietary product candidate Talglobin01 proves TALEN® Can specifically and effectively correct the mutant β-globin gene that causes sickle cell disease
New York, December 11, 2021 (Global News Agency)- Cellulite (Nasdaq:CLLS), a clinical-stage biotechnology company that uses its pioneering TALEN® gene editing platform to develop innovative therapies for the treatment of serious diseases, today announced the BALLI-01 phase 1 study of its allogeneic CAR-T cell therapy UCART22 The preliminary results of TALGlobin01 target CD22 drug candidates for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preclinical data of TALGlobin01, which is a 63-year-old homozygous SCD patient ( HbSS) autologous cell therapy candidate productroad The American Society of Hematology (ASH) annual meeting was held in Atlanta, Georgia.
“We are excited by the encouraging preliminary results obtained in the BALLI-01 study for fludarabine, cyclophosphamide, and alemtuzumab (FCA) patients who received UCART22 after lymphatic depletion. The addition of alemtuzumab to the amide (FC) is proven to be safe, can improve host-lymphocyte suppression, and promote the expansion of UCART22, which is related to anti-leukemia activity,” said Chief Medical Officer Carrie Brownstein, MD. “We believe these initial data support our mission to develop UCART22 for r/r B-ALL patients, who still urgently need additional treatment options, especially those who have failed CD19 treatment.”
BALLI-01 Investigating UCART22 candidate products in R/R B-ALL
BALLI-01 is a phase 1 open-label dose escalation study to evaluate the safety, maximum tolerated dose (MTD) and preliminary anti-leukemia activity of UCART22 in patients with r/r B-ALL. Other endpoints include the characterization of the expansion, transport and persistence of UCART22 cells.
The poster presentation includes preliminary data from patients who received UCART22 dose level 2 (DL2) and intermediate dose level 2 (DL2i) after FCA lymphadenectomy. Alemtuzumab is added to FC to deepen and maintain host lymphocyte suppression, thereby promoting the expansion and persistence of UCART22.
As of the clinical deadline of October 1, 2021, 12 patients had received lymphadenectomy; 11 received UCART22, of which 6 received UCART22 and FCA.The enrolled patients are mainly male [n=7], Young (median age 30 [range 20-61]), and most have recurrent genetic abnormalities, including CRFL2 (cytokine receptor-like factor 2) rearrangement.In addition, the enrolled patients received a large amount of pretreatment with a median of 3 previous treatment lines [range 2-6]. Three-quarters of patients have received blinatumomab,…
The full story can be found on Benzinga.com
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