What type of study is this?

This is a Human Clinical Trial study (also classified as: Pre-Registered Trial).

What question did this study set out to answer?

This research aims to evaluate the safety and efficacy of lenalidomide with CD19 CAR T-cell therapy in relapsed or refractory chronic lymphocytic leukemia (CLL).

December 8, 2025BloodOpen Access

Safety and preliminary efficacy of combined lenalidomide and CD19 CAR T-cell therapy in relapsed/refractory CLL: A phase I study

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Authors

YSYuliya SeradaVitebsk State University named after P.M. Masherov DLDzmitry LutskovichBelarusian Research Center For Pediatric Oncology and Hematology ENElizaveta NaberezhnayaInstitute of Bioorganic Chemistry

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Implication

Phase I trial finds combined therapy improves complete response and safety in relapsed chronic lymphocytic leukemia.

Key Points

This research aims to evaluate the safety and efficacy of lenalidomide with CD19 CAR T-cell therapy in relapsed or refractory chronic lymphocytic leukemia (CLL).
Open-label, non-randomized Phase I/II clinical trial (VTB-CLL002)
Patients received escalating doses of autologous T cells with a CD19 CAR-T cell construct
Safety assessed for cytokine release syndrome, hemophagocytic lymphohistiocytosis, and more
Primary efficacy endpoints included overall response rate and minimal residual disease status.
8 patients enrolled by July 31, 2025; median follow-up of 9 months.
All patients developed cytokine release syndrome, with 42.8% experiencing grade 3 or higher symptoms.
Overall response rate was 100%, with all patients achieving complete response that was minimal residual disease-negative.

Cite This Study

Serada et al. (2025) studied this question.

synapsesocial.com/papers/69362f634fa91c937236ddb5 https://doi.org/10.1182/blood-2025-2371

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Safety and preliminary efficacy of combined lenalidomide and CD19 CAR T-cell therapy in relapsed/refractory CLL: A phase I study

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Key Points

Cite This Study

Safety and preliminary efficacy of combined lenalidomide and CD19 CAR T-cell therapy in relapsed/refractory CLL: A phase I study

Discussion

Member takes

Implication

Key Points

Cite This Study

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