Combining anti-CD19 CAR T-cells with Lenalidomide in relapsed/refractory CLL/SLL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I/II open-label interventional study enrolling adults with relapsed or refractory CD19+ CLL or SLL who have been on ibrutinib for at least 3 months. After lymphodepletion, patients receive autologous anti-CD19 CAR T cells at escalating doses (DL1–DL3) with concurrent Lenalidomide and obinutuzumab as preconditioning and maintenance, followed by MRD-guided consolidation where applicable. Phase I focuses on safety, tolerability, and CAR T-cell pharmacokinetics, while Phase II assesses overall response rate, progression-free and overall survival, and MRD negativity. Eligible participants must have failed prior therapy, adequate organ function, and no active GVHD or significant ibrutinib-related toxicity.

Why it matters

Who can join: the full rules

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

Where it's running

• Hematology/Oncology department
  Vitebsk, Select A State, Belarus Recruiting

Study contacts

• Study coordinator: Mikalai Katsin
• Email: oncogemvocod@gmail.com
• Phone: 80297188691

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.