Chronic Lymphocytic Leukaemia (CLL)Phase 1/2VTB-CLL002NCT06762431
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.
A Phase 1/2 study testing Lenalidomide and Obinutuzumab Injection [Gazyva] in people with Chronic Lymphocytic Leukaemia (CLL) and Small Lymphocytic Lymphoma (SLL), run by Vitebsk Regional Clinical Cancer Centre at 1 site in Belarus.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukaemia (CLL), Small Lymphocytic Lymphoma (SLL)
- What is being tested?
- Lenalidomide and Obinutuzumab Injection [Gazyva]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelarus
- Study dates
- 14 May 2024to 31 Aug 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus1 site, 1 recruiting
- Recruiting
Hematology/Oncology department
Vitebsk, Select A State, 210023
Mikalai Katsin, 80297188691, katin@mail.com
About this study
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.
Read the detailed description
Patients receive ibrutinib 420 mg daily for 3 months before CAR T-cell infusion. Obinutuzumab 1000 mg is administered 14 days before leukapheresis to reduce circulating CLL cells. Lymphodepletion consists of fludarabine 25 mg/m² and cyclophosphamide 250 mg/m² on days -5 to -3. In a 3+3 dose-escalation design, patients receive a single infusion of 25 × 10⁶ (DL1), 50 × 10⁶ (DL2), or 100 × 10⁶ (DL3) autologous CD19 CAR T cells. Lenalidomide 10 mg is administered orally on days 0 through 6. 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.
The main purposes of the Phase I part are:
- To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability.
- To explore the pharmacokinetics of CAR-T cells.
The main purposes of the Phase II part are:
- Overall response rate, including complete response (CR) and partial response (PR) rates.
- Progression-free survival rates.
- Overall survival rates.
- MRD negativity rates measured by flow cytometry.
- Being tested
- Lenalidomide, Obinutuzumab Injection [Gazyva]
- Keywords
- anti-CD19 CAR T-cells, Lenalidomide, Ibrutinib
- Medical subject headings
- Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
Lenalidomide 10mg per os 0- 6 days
LenalidomideDrug
Also called Revlimid
Lenalidomide 10 mg per os 1 -14 days
Obinutuzumab Injection [Gazyva]Biological
Combined with Lenalidomide 10 mg per os 1- 14 days for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Low dose antiCD19 CAR T-cells plus Lenalidomide | Experimental | 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. Receives: Drug: Lenalidomide; Biological: Obinutuzumab Injection [Gazyva] |
| Medium dose of antiCD19 CAR T-cell therapy plus Lenalidomide | Experimental | 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. Receives: Drug: Lenalidomide; Biological: Obinutuzumab Injection [Gazyva] |
| High dose antiCD19 CAR T-cell therapy plus Lenalidomide | Experimental | Phase 1: Phase 1: Determine safety of IL-7/IL-15 expanded 100x10^6 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. 9 patients per cohort. Receives: Drug: Lenalidomide; Biological: Obinutuzumab Injection [Gazyva] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events incidence
Measured: 24 months
Safety
- To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability.
- To explore the pharmacokinetics of CAR-T cells.
Measured: 24 months
Secondary outcomes (1)
Efficacy
Measured: - Overall response rate, including complete response (CR) and partial response (PR) rates. - Progression-free survival rates. - Overall survival rates. - MRD negativity rates measured by flow cytometry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start14 May 2024
- Primary completion9 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukaemia (CLL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitebsk Regional Clinical Cancer Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Republican Scientific and Practical Center for children's Oncology, Hematology and Immunology
- Responsible party
- Principal investigator, Mikalai Katsin, Vitebsk Regional Clinical Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762431
- Sponsor's protocol ID
- VTB-CLL002
- Acronym
- VTB-CLL002
- Status last verified
- Aug 2026
- First submitted
- 30 Dec 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided