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NCT06762431: VTB-CLL002

Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.

ENROLLING BY INVITATION Phase 1, PHASE2 Last updated 7 January 2025
What this trial tests

Phase 1, PHASE2 trial testing Lenalidomide in Chronic Lymphocytic Leukaemia (CLL) in 60 participants. Enrolling by invitation.

Timeline
4 November 2024
Primary endpoint
9 March 2026
31 August 2026

Quick facts

Lead sponsorVitebsk Regional Clinical Cancer Centre
PhasePhase 1, PHASE2
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment60
Start date4 November 2024
Primary completion9 March 2026
Estimated completion31 August 2026
Sites1 location across Belarus

Drugs / interventions tested

Conditions studied

Sponsor

Vitebsk Regional Clinical Cancer Centre

Who can join

18 and older, any sex, with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I/II interventional, open-label treatment study designed to evaluate the safety and efficacy of concomitant therapy with anti-CD19 CAR T-cells and Lenalidomide in adult patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who have been pretreated with Ibrutinib for 3 months prior to leukapheresis.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mechanisms of Resistance to CAR T-Cells and How to Overcome Them.
    Legato L, Bisio M, Fasano F, Benevolo Savelli C, et al · · 2025 · cited 3× · PMID 40981226 · DOI 10.3390/mps8050108
  2. Targeting CAR-T cell exhaustion in non-Hodgkin lymphoma: mechanistic insights and emerging clinical strategies.
    Rao A, Darwish C, Campbell KS, Khanal R, et al · · 2026 · PMID 42093982 · DOI 10.3389/fimmu.2026.1727926
  3. Potential of small-molecule targeted drugs in combination with CAR-T cell therapy for hematologic lymphomas.
    Tang W, Yu S. · · 2026 · PMID 41993181 · DOI 10.3389/fimmu.2026.1792910
  4. Combining Small-Molecular Compounds With CAR T-Cell Therapy: Novel Strategies for Enhanced Cancer Immunotherapy.
    Yi R, Zhang Z, Yang Y, Zhu H. · · 2026 · PMID 41978748 · DOI 10.1002/cai2.70053

Verify or expand the search:

Other trials of Lenalidomide

Trials testing the same drug.

Other recruiting trials for Chronic Lymphocytic Leukaemia (CLL)

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06762431.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing