The minimal residual disease-positive cohort opens as part of the pivotal-stage development of Soficabtagene Geleucel (Sofi-cel), an off-the-shelf CAR-T cell therapy under evaluation for relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma (T-ALL/T-LBL)

Allotera Therapeutics, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies for hematological malignancies, today announced the opening of the minimal residual disease (MRD)-positive cohort of its global pivotal T-RRex study of Soficabtagene Geleucel (Sofi-cel).

“Opening the MRD-positive cohort allows us to reach patients earlier in their disease course, before relapse, when we believe Sofi-cel may have the potential to provide meaningful clinical benefit,” said Kumar Srinivasan, Ph.D., M.B.A., President and Chief Executive Officer of Allotera. “This expansion of our T-RRex study demonstrates our commitment to exploring the potential of Sofi-cel across the treatment continuum for patients with T-ALL or T-LBL.”

“MRD positivity after standard therapy is one of the strongest predictors of relapse, yet few therapies are directed specifically at eliminating residual disease,” said Cherry Thomas, M.D., Chief Medical Officer of Allotera. “By evaluating Sofi-cel in patients with MRD positivity, we aim to determine whether treatment can achieve MRD-negative remission and ultimately improve long-term clinical outcomes.”

T-RRex is a global, single-arm, open-label Phase 2 study with a pivotal cohort evaluating Sofi-cel in patients with R/R T-ALL/T-LBL. The study is also evaluating Sofi-cel in patients who are in remission and remain MRD-positive following standard therapy. The study is being conducted at 18 clinical sites in the U.S. and Australia.

About Soficabtagene Geleucel (Sofi-cel)

Sofi-cel is an allogeneic, off-the-shelf, CD7-targeted CAR-T cell therapy being developed for T-cell cancers. Allotera uses CRISPR/Cas9 gene editing to delete CD7 and the T-cell receptor alpha constant (TRAC) genes, an approach intended to prevent CAR-T cell fratricide and mitigate the risk of graft-versus-host disease.

Sofi-cel is manufactured in the United States using healthy donor-derived T cells, which is intended to avoid malignant cell contamination that can occur in the autologous CAR-T setting. Sofi-cel is currently being evaluated in a global pivotal clinical trial for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma and patients who are in remission but remain MRD-positive following standard therapy. More information on the pivotal trial is available at ClinicalTrials.gov, identifier NCT06514794.

Sofi-cel has received Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations from the U.S. Food and Drug Administration for the treatment of relapsed or refractory T-ALL/T-LBL, as well as Priority Medicines, or PRIME, designation in the European Union. RMAT and PRIME designations provide increased agency support to expedite the development and review of promising therapies for patients with medical need. Sofi-cel was also selected to participate in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program.

About Allotera Therapeutics

Allotera Therapeutics, Inc. is a clinical-stage biotechnology company developing allogeneic, off-the-shelf CAR-T cell therapies for cancer. The company is advancing Soficabtagene Geleucel, or Sofi-cel, its lead CD7-targeted CAR-T cell therapy, through a global pivotal study for relapsed or refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. Allotera’s gene-editing and manufacturing approach is intended to address key biological and practical barriers that have limited CAR-T therapy development in T-cell cancers. Headquartered in St. Louis, Missouri, Allotera is working to expand what off-the-shelf cell therapy can mean for patients with aggressive hematological malignancies. For more information, visit www.alloteratx.com.

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"Opening the MRD-positive cohort allows us to reach patients earlier in their disease course, before relapse, when we believe Sofi-cel may have the potential to provide meaningful clinical benefit," said Kumar Srinivasan, Ph.D., M.B.A., President and CEO.