Clinical trial · Interventional
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.
NCT06762431CI-TRIAL-00121860VTB-CLL002recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukaemia (CLL) | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
| Small Lymphocytic Lymphoma (SLL) | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Obinutuzumab Injection [Gazyva] | Biological | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low dose antiCD19 CAR T-cells plus Lenalidomide
- description
- Phase 1: Determine safety of IL-7/IL-15 expanded 25x10\^6 antiCD19 CAR-T cells with concomitant Lenalidomide 10 mg per os days 0-6 in patients with relapsed/refractory CLL. Patients will be enrolled in a 3+3 fashion. At day 28, patients with measurable residual disease (MRD)-positive disease are eligible for lenalidomide 10 mg 1-14 days per os plus obinutuzumab 1000 mg IV 1,8,15 days on cycle 1 and on day 1 on 2-6 cycles consolidation, whereas patients with MRD-negative disease receive lenalidomide 10 mg per os 1-14 days maintenance for 3 cycles. 3 patients per cohort.
- interventionNames
- Drug: Lenalidomide
- Biological: Obinutuzumab Injection [Gazyva]
- type
- EXPERIMENTAL
- label
- Medium dose of antiCD19 CAR T-cell therapy plus Lenalidomide
- description
- Phase 1: Phase 1: Determine safety of IL-7/IL-15 expanded 50x10\^6 antiCD19 CAR-T cells with concomitant Lenalidomide 10 mg per os days 0-6 in patients with relapsed/refractory CLL. Patients will be enrolled in a 3+3 fashion. At day 28, patients with measurable residual disease (MRD)-positive disease are eligible for lenalidomide 10 mg 1-14 days per os plus obinutuzumab 1000 mg IV 1,8,15 days on cycle 1 and on day 1 on 2-6 cycles consolidation, whereas patients with MRD-negative disease receive lenalidomide 10 mg per os 1-14 days maintenance for 3 cycles. 3 patients per cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.