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Updated: Jun 5, 2026
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Chimeric Antigen Receptor T Cell Manufacturing on an Automated Cell Processor
Published on: August 18, 2023
Non-gene-edited, CD19-targeted, allogeneic CAR-T cell therapy for relapsed or refractory B-cell acute lymphoblastic
Chenxue Wu1,2, Lei Xue1, Miaomiao Wu1
1Department of Hematology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, China.
Bone Marrow Transplantation
|June 3, 2026
Summary
ThisCAR-T, a novel allogeneic CAR-T therapy, shows promising safety and efficacy for relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), offering a potential alternative to autologous treatments.
Area of Science:
- Hematology
- Immunotherapy
- Oncology
Background:
- Autologous CAR-T cell therapy is effective for R/R B-ALL but faces manufacturing, cost, and accessibility challenges.
- Gene-edited allogeneic CAR-T cells present an alternative but raise concerns about genomic instability and GVHD.
- ThisCAR-T is a non-gene-edited, CD19-directed allogeneic CAR-T product for R/R B-ALL.
Purpose of the Study:
- To assess the safety and efficacy of ThisCAR-T in patients with R/R B-ALL.
- To evaluate dose escalation of ThisCAR-T in a phase 1 study.
Main Methods:
- A phase 1 study treated eleven patients with escalating doses of ThisCAR-T (1-5 × 10^6 cells/kg).
- Safety was assessed by monitoring cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
- Efficacy was evaluated by remission rates and survival outcomes.
Main Results:
- Eight of ten patients experienced CRS (7 grade 1-2, 1 grade 3).
- Two patients had ICANS (grade 1 and grade 4). No graft-versus-host disease (GVHD) was observed.
- Eight of nine evaluable patients achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) by day 28. One-year progression-free survival was 30%, and overall survival was 40%.
Conclusions:
- ThisCAR-T demonstrated a favorable safety profile in R/R B-ALL patients.
- The non-gene-edited allogeneic CAR-T product showed promising antileukemic activity.
- ThisCAR-T holds potential as a novel therapeutic option for R/R B-ALL.
