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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06762431
- Acronym / sponsor ID
- VTB-CLL002 / VTB-CLL002
- Keywords
- anti-CD19 CAR T-cells, Lenalidomide, Ibrutinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Vitebsk Regional Clinical Cancer CentreUniversity, hospital or other
- Collaborators
- Republican Scientific and Practical Center for children's Oncology, Hematology and Immunology
- Study start
- 14 May 2024 (actual)
- Primary completion
- 9 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose antiCD19 CAR T-cells plus Lenalidomide | Experimental | Drug: Lenalidomide, Biological: Obinutuzumab Injection [Gazyva]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. |
| Medium dose of antiCD19 CAR T-cell therapy plus Lenalidomide | Experimental | Drug: Lenalidomide, Biological: Obinutuzumab Injection [Gazyva]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. |
| High dose antiCD19 CAR T-cell therapy plus Lenalidomide | Experimental | Drug: Lenalidomide, Biological: Obinutuzumab Injection [Gazyva]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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: RevlimidLenalidomide 10mg per os 0- 6 days | Drug | High dose antiCD19 CAR T-cell therapy plus Lenalidomide, Low dose antiCD19 CAR T-cells plus Lenalidomide, Medium dose of antiCD19 CAR T-cell therapy plus Lenalidomide |
| LenalidomideAlso: RevlimidLenalidomide 10 mg per os 1 -14 days | Drug | High dose antiCD19 CAR T-cell therapy plus Lenalidomide, Low dose antiCD19 CAR T-cells plus Lenalidomide, Medium dose of antiCD19 CAR T-cell therapy plus Lenalidomide |
| Obinutuzumab Injection [Gazyva]Combined with Lenalidomide 10 mg per os 1- 14 days for 6 cycles | Biological | High dose antiCD19 CAR T-cell therapy plus Lenalidomide, Low dose antiCD19 CAR T-cells plus Lenalidomide, Medium dose of antiCD19 CAR T-cell therapy plus Lenalidomide |
Primary outcome
Adverse events incidence
Time frame: 24 months
Safety
Time frame: 24 months
* 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.
1 secondary outcome
Efficacy
Time frame: - 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikalai Katsin (80297188691, oncogemvocod@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events incidence (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.