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.

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVitebsk Regional Clinical Cancer Centre

About this trial

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.

Eligibility criteria

Qualifiers

Documented CD19+ CLL or SLL

Patients must have failed at least 1 prior regimen

Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity

ECOG Performance status 0 or 1

Disqualifiers

CLL patients with known or suspected transformed disease (i.e. Richter's transformation).

Pregnant or lactating women.

Uncontrolled active infection.

Active hepatitis B or hepatitis C infection.

Trial design

Treatments tested in this trial

  • Lenalidomide
  • Lenalidomide
  • Obinutuzumab Injection [Gazyva]

Treatment groups

24 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Vitebsk Regional Clinical Cancer Centre

Lead sponsor

Republican Scientific and Practical Center for children's Oncology, Hematology and Immunology

Collaborator