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NCT06762431RecruitingPhase 1/2

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.

Source: ClinicalTrials.gov · Last updated 13 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
24 (estimated)
First submitted
30 Dec 2024
Start date
14 May 2024
Primary completion date
9 Aug 2026
Lead sponsor
Vitebsk Regional Clinical Cancer Centre
NCT number
NCT06762431

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 24
  • From 14 May 2024 to the primary completion date, 9 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent use of systemic steroids or chronic use of immunosuppressant medications.

Other illness

  • CLL patients with known or suspected transformed disease (i.e. Richter's transformation).
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • 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

Other

  • Pregnant or lactating women.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hematology/Oncology department
Coordinator of this site? Confirm its status
VitebskBelarusRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.