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.

Official record

Identifier

NCT06762431

Recruiting locations

country

Belarus

Interventions studied

LenalidomideLenalidomideObinutuzumab Injection [Gazyva]

Lead sponsor

Vitebsk Regional Clinical Cancer Centre

Target enrolment

24 participants

Study type

INTERVENTIONAL

Phase

Phase 1/2

Status

Recruiting

First posted

Jan 7, 2025

Last updated on the registry

Aug 13, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* Documented CD19+ CLL or SLL
* Patients must have failed at least 1 prior regimen
* Patients must be currently receiving ibrutinib for at least 3 months prior to enrollment in the study and:
* Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
* ECOG Performance status 0 or 1
* 18 years of age and older
* Adequate organ system function including:

Creatinine \< 1.6 mg/dl ALT/AST \< 3x upper limit of normal Total Bilirubin \<2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.

* Have no active GVHD and require no immunosuppression
* Are more than 6 months from transplant
* No contraindications for leukapheresis
* Left Ventricular Ejection fraction \>50%
* Gives informed consent

Exclusion Criteria:

* 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.
* Concurrent use of systemic steroids or chronic use of immunosuppressant medications.
* Any uncontrolled active medical disorder
* HIV infection.
* Patients with active CNS involvement with malignancy.
* Class III/IV cardiovascular disability according to the New York Heart Association Classification.
* Subjects with clinically apparent arrhythmia or arrhythmias who are not stable

Indexed under

Lymphoma