Allotera Therapeutics secures $35M to advance pivotal T‑RRex trial of Sofi‑cel, its CRISPR‑engineered allogeneic CAR‑T therapy targeting CD7 in relapsed/refractory T‑ALL and T‑LBL, with broad FDA and EMA regulatory designations supporting late‑stage development.
Written By: Umesh Hanumante,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Allotera Therapeutics has strengthened the pivotal development of its investigational allogeneic CAR-T cell therapy soficabtagene geleucel (Sofi-cel) after securing $35 million in new financing. The investment will primarily support the ongoing global pivotal T-RRex trial (NCT06514794) evaluating Sofi-cel in patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL), two aggressive blood cancers with limited treatment options following relapse.
Gene-edited off-the-shelf CAR-T platform targets longstanding challenges
CAR-T therapy development for T-cell malignancies has been particularly challenging because many therapeutic targets are also present on the therapeutic T cells themselves, leading to CAR-T cell fratricide during manufacturing. Sofi-cel addresses this obstacle using healthy donor-derived T cells, providing an allogeneic, off-the-shelf treatment that is immediately available without requiring patient-specific cell manufacturing.
The therapy targets CD7 and incorporates CRISPR/Cas9 gene editing to delete both the CD7 and T-cell receptor alpha constant (TRAC) genes. This approach helps prevent CAR-T cell fratricide while reducing the risk of graft-versus-host disease. Manufacturing from healthy donor cells may also lower the risk of malignant cell contamination that can occur with autologous CAR-T products.
Regulatory momentum supports pivotal program
Sofi-cel is currently being evaluated in the global pivotal T-RRex study for patients with relapsed or refractory T-ALL and T-LBL.
The investigational therapy has received multiple U.S. Food and Drug Administration designations, including Breakthrough Therapy, Regenerative Medicine Advanced Therapy (RMAT), Fast Track, Orphan Drug, and Rare Pediatric Disease designations. In Europe, it has also been granted PRIME (Priority Medicines) designation. In addition, Sofi-cel was selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot Program, providing additional regulatory support during product development.
Commenting on the company’s progress, Chief Executive Officer Kumar Srinivasan, Ph.D., M.B.A., said Allotera has evolved into a pivotal-stage cell therapy company focused on bringing off-the-shelf CAR-T therapies to patients with T-cell cancers. He added that the new funding will strengthen clinical execution, manufacturing capabilities, and patient engagement as the company advances Sofi-cel through late-stage development.
Financing supports late-stage development and manufacturing expansion
The newly announced $35 million financing, comprising equity and venture debt, increases Allotera Therapeutics’ total capital raised to $150 million, following its $115 million Series C financing announced in late 2025. Beyond supporting the T-RRex study, the proceeds will expand manufacturing capacity, strengthen operational infrastructure, and support continued organizational growth.
The financing extension attracted participation from existing investors alongside Lightchain Capital, BioGenerator, and new investors including Blood Cancer United’s Therapy Acceleration Program (TAP). Bank of California provided the venture debt component.
In parallel, Allotera has entered a strategic partnership with Blood Cancer United, through which TAP will provide scientific expertise, clinical development support, key opinion leader engagement, patient education, and community outreach resources.
Formerly known as Wugen, Inc., the company has adopted the name Allotera Therapeutics to reflect its exclusive focus on advancing allogeneic, off-the-shelf cell therapies for patients with aggressive hematologic malignancies. With pivotal development underway and broad regulatory support already in place, the latest financing is expected to sustain clinical, manufacturing, and commercialization activities as Sofi-cel advances toward potential regulatory submission.
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About the Writer
Umesh Hanumante (M.Pharm) (LinkedIn) is a pharmacy professional and healthcare writer with a background in Regulatory Affairs, pharmaceutical innovation, and clinical research. He has around two years of industry experience as an Executive PMT at Troikaa Pharmaceuticals Ltd and qualified GPAT 2024. His areas of interest include regulatory compliance, dossier preparation, clinical trials, emerging therapies, and advancements in the global pharmaceutical and healthcare sector.