Allotera Opened New Cohort in T-RRex Leukemia Study
The Phase 2 study for T-cell malignancies now includes patients who remain minimal residual disease-positive.
Updated on Sept. 23, 2026 in Biotech
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Allotera Therapeutics has expanded its global Phase 2 T-RRex study of Soficabtagene Geleucel to include a cohort of patients who are minimal residual disease-positive. This research-stage immunotherapy aims to address relapsed or refractory T-cell acute lymphoblastic leukemia and lymphoma.
Why it matters
By targeting patients earlier in their disease course, Allotera seeks to determine if gene-edited therapy can achieve minimal residual disease-negative remission. The trial aims to improve clinical outcomes before patients face full-scale relapse.
The T-RRex study evaluates Soficabtagene Geleucel across 18 clinical sites in the U.S. and Australia. The therapy utilizes CRISPR/Cas9 gene editing to delete CD7 and T-cell receptor alpha constant genes.
The players
Allotera Therapeutics
A St. Louis-based biotech company focused on developing CRISPR-edited immunotherapy products for oncology.
The details
Soficabtagene Geleucel involves modifying healthy donor-derived T cells—immune cells that can be programmed to attack cancer—using CRISPR/Cas9, a molecular tool for precise DNA editing. By deleting CD7 and TRAC (T-cell receptor alpha constant) genes, the therapy aims to generate an engineered cell product that survives and remains effective within the patient. The current study cohort specifically tracks patients in remission who still show signs of minimal residual disease, the low level of cancer cells remaining after initial standard therapy.
Timeline
September 23, 2026: Allotera Therapeutics announced the opening of the new cohort.
The Tech Race
The T-RRex study represents an effort to establish Soficabtagene Geleucel as a viable T-cell immunotherapy for hard-to-treat hematologic malignancies. By securing FDA Breakthrough Therapy and RMAT designations, alongside EU PRIME status, the company is positioning the platform for accelerated regulatory review.
This development is currently limited to participants in the research-stage T-RRex clinical trial at sites in the U.S. and Australia. Eligible patients should consult their oncology team regarding potential participation in the new study cohort.
The takeaway
The addition of this cohort signals a move toward early intervention for patients with residual T-cell malignancies. Watch for future Phase 2 trial results to see if the therapy successfully converts residual disease-positive patients to a disease-negative status.
Further reading
For more on the development of novel cell therapies, visit Biotech.
More information
View detailed clinical trial study information on the primary registry.
Source note: This article includes information reported by Firstwordpharma.
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