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Can a One-Two punch of CAR-T and lenalidomide beat tough leukemia?

NCT ID NCT06762431

Cure Sponsor: Vitebsk Regional Clinical Cancer Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This trial is testing whether combining anti-CD19 CAR-T cell therapy with the drug lenalidomide can safely and effectively treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has returned or not responded to prior treatments. Participants will receive CAR-T cells along with lenalidomide, and some will also get obinutuzumab. The goal is to see if this combination can produce lasting remissions and improve outcomes for people with this hard-to-treat blood cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anti-CD19 CAR T-cell therapy combined with lenalidomide (and obinutuzumab in some cycles)
What this could lead to
If successful, this combination could offer a durable, treatment-free remission for people with relapsed or refractory CLL, potentially a cure.
What could go wrong
This is an early-phase trial with a small number of patients, so results may not hold up. CAR-T therapy carries risks like severe immune reactions, infections, and prolonged low blood counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia Leukemia, B-Cell

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukaemia (CLL) Small lymphocytic lymphoma (SLL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hematology/Oncology department

    RECRUITING

    Vitebsk, Select A State, 210023, Belarus

More trials for these conditions

Other studies related to the condition(s) this trial covers.