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Engineered immune cells take aim at Hard-to-Treat leukemia

NCT ID NCT06927466

Cure Sponsor: Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time

Summary

This early-stage trial is testing an investigational therapy called B019, which uses a patient's own immune cells engineered to recognize and attack leukemia cells. The study focuses on people with B-cell acute lymphoblastic leukemia that has returned or not responded to standard treatments. The main goal is to assess the safety and tolerability of B019, while also looking at how well it works and how long any response might last.

What this could mean

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

Active substance
B019, a CAR-T cell therapy given as an intravenous infusion
What this could lead to
If successful, this could lead to a new treatment option that may put leukemia into remission for people who have run out of standard options.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and effectiveness are not yet proven. CAR-T therapy can cause serious side effects, including cytokine release syndrome and neurological issues.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 33 people

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

Started

Sep 2024

Expected to finish

Jun 2028

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

3 to 25 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: 1. The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form； 2. Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia； 3. Documentation of CD19/CD22 tumor expression 3\. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \>3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion. \- Exclusion Criteria: 1. Active CNS involvement by malignancy； 2. Isolated extramedullary leukemia recurrence； 3. Subjects with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening; 4. Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal. 4\. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab. 7\. Other situations deemed inappropriate for participation in this study by the investigator. \-

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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.

Relapsed or refractory 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 places running it

    8 sites. 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

  • Children's Hospital of Shanghai

    RECRUITING

    Shanghai, China

  • Children's Hospital of Soochow University

    RECRUITING

    Suzhou, China

  • Jiangxi Province pediatric hospital

    RECRUITING

    Nanchang, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, China

  • Shanghai Children's Medical Center

    RECRUITING

    Shanghai, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

  • Tongji Hospital

    RECRUITING

    Wuhan, China

More trials for these conditions

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