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Engineered immune cells take on tough leukemia

NCT ID NCT04150497

Disease control Sponsor: Cellectis S.A. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing a new treatment called UCART22 for people with a type of blood cancer called B-cell acute lymphoblastic leukemia that has come back or not responded to standard treatments. UCART22 uses donor immune cells that are engineered in a lab to recognize and attack cancer cells. The trial will enroll about 52 participants to evaluate the safety of the therapy and see if it can shrink tumors. It is an early-stage study, so the main goals are to find the right dose and check for side effects.

What this could mean

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

Active substance
UCART22 (allogeneic engineered T-cells targeting CD22) and alemtuzumab (CLLS52) for lymphodepletion
What this could lead to
If successful, this could provide a new treatment option for patients with hard-to-treat B-cell acute lymphoblastic leukemia who have run out of standard therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 52 participants. The therapy may cause serious side effects, and it is not yet known if it will effectively control the disease long-term.

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 52 people

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

Started

Oct 2019

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

15 to 50 years

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: * B-ALL blast cells expressing CD22 * Diagnosed with R/R B-ALL * Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen Exclusion Criteria: -Prior cellular therapy or investigational cellular or gene therapy within 90 days prior to enrollment

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma Recurrence

As listed by the trial registrant

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

B-cell acute lymphoblastic leukemia

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • CHU Rennes - Hopital Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • CHU de Nantes - Hôtel-Dieu

    RECRUITING

    Nantes, 44093, France

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Hôpital Lyon Sud

    RECRUITING

    Pierre-Bénite, 69310, France

  • Hôpital Robert Debré - Service d'hémato-immunologie

    RECRUITING

    Paris, 75019, France

  • Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie

    RECRUITING

    Paris, 75010, France

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center (MSKCC) David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • Sarah Cannon - Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sarah Cannon - HCA Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon - St. David's South Austin Medical Center

    RECRUITING

    Austin, Texas, 78704, United States

  • Sarah Cannon - Texas Transplant Institute at Methodist Hospital

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of California, Los Angeles (UCLA) - Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60647, United States

  • University of Colorado - Aurora Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Weill Medical College of Cornell University

    WITHDRAWN

    New York, New York, 10065, United States

More trials for these conditions

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