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New combo therapy aims to wipe out leukemia cells for good

NCT ID NCT05262673

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests a combination therapy for B-cell acute lymphoblastic leukemia (B-ALL). It uses specially engineered immune cells (CAR-T cells and CTLs) followed by a dendritic cell vaccine to target multiple cancer markers. The goal is to achieve a very deep remission, measured by advanced genetic testing, that could mean a low risk of relapse. Only 10 participants will be enrolled to assess safety and initial effectiveness.

What this could mean

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

Active substance
Antigen-specific T cells (CAR-T/CTL) and dendritic cell vaccine
What this could lead to
If successful, this approach could lead to long-term remission for B-ALL patients without needing further treatment.
What could go wrong
This is a very early Phase 1 trial with only 10 participants, so safety and effectiveness are not yet proven. There are risks of serious 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

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

Participants

10 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 65 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. High-burden (≥30% blast cells) B-ALL tumor specimen for clonal IgH identification and CTL/DC vac preparation is required 3. Expression of CD19, CD22, CD20, CD10 or CD123 is determined in malignant cells by flow cytometry or immuno-histochemical staining. 4. Karnofsky performance status (KPS) score is higher than 60 and life expectancy \> 3 months. 5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0mg/dL. 6. No cell separation contraindications. 7. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. Active bacterial, fungal or viral infection not controlled by adequate treatment. 3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 4. Pregnant or nursing women may not participate. 5. History of glucocorticoid for systemic therapy within the week prior to entering the test. 6. Previously treatment with any gene therapy products. 7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma

As listed by the trial registrant

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

B-cell acute lymphoblastic leukemia

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.