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Engineered immune cells take aim at leukemia that evades standard therapy

NCT ID NCT04430530

Disease control Sponsor: Shenzhen Geno-Immune Medical Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times

Summary

This trial investigates a new type of CAR-T cell therapy for people with B-cell acute lymphoblastic leukemia (B-ALL) whose cancer has stopped responding to anti-CD19 treatment. The therapy uses a patient's own immune cells, modified to target several other markers on leukemia cells (CD22, CD123, CD38, CD10, and CD20). The study aims to see if this approach is safe and can shrink or eliminate the cancer. It enrolls children and adults over 6 months old from multiple medical centers.

What this could mean

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

Active substance
4SCAR-T cells targeting CD22, CD123, CD38, CD10, and CD20
What this could lead to
If successful, this approach could offer a new treatment option for patients with B-cell leukemia that no longer responds to standard anti-CD19 therapy.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so results may not apply broadly. CAR-T therapy can cause severe side effects like cytokine release syndrome.

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

100 people

The number who actually took part.

Started

Jun 2026

Finished

Jul 2026

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

6 months to 75 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. Age older than 6 months. 2. B cell malignancies relapsed after anti-CD19 immunotherapy. 3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20. 4. The KPS score over 80 points, and survival time is more than 1 month. 5. Greater than Hgb 80 g/L. 6. No contraindications to blood cell collection. Exclusion Criteria: 1. Complications with other active diseases, and difficult to assess patient response. 2. Bacterial, fungal, or viral infection unable to control. 3. Living with HIV. 4. Active HBV and HCV infection. 5. Pregnant and nursing mothers. 6. Under systemic steroid use within a week of the treatment. 7. Judged difficult to cooporate for continued evaluation.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia

As listed by the trial registrant

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

CD19 negative B-cell malignancies

Contacts and locations

Locations

  • Shenzhen Geno-Immune Medical Institute

    Shenzhen, Guangdong, 518000, China

More trials for these conditions

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