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Double-Barreled immune attack aims to wipe out T-ALL

NCT ID NCT05277753

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-phase trial tests a two-part immune therapy for people with T-cell acute lymphoblastic leukemia (T-ALL). First, patients receive specially engineered T cells (CAR-T) that target multiple markers on leukemia cells. Then, they get a booster with cytotoxic T cells and a dendritic cell vaccine to strengthen the immune response. The goal is to eliminate even tiny traces of leukemia, potentially leading to long-term remission.

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 (DCvac)
What this could lead to
If successful, this combination therapy could achieve deep remission in T-ALL patients, potentially reducing relapse risk and pointing toward long-term disease control without 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. The therapy involves complex cell engineering, and there is a risk of serious side effects or the treatment not working as hoped.

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) bone marrow sample for NGS TCR clonal identification and CTL/DC vac preparation is required 3. Expression of CD7, CD5, CD317, CD47, CD99, CD38 or TRBC1/2 is determined in malignant cells by flow cytometry or immuno-histochemical staining. 4. Karnofsky performance status (KPS) score is higher than 80 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 ≤ 2.0 mg/dL. 6. Hgb ≥ 80g/L. 7. No cell separation contraindications. 8. 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. Previous 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.

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma T-cell acute lymphoblastic leukemia

As listed by the trial registrant

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

T-cell acute lymphoblastic leukemia

Contacts and locations

Locations

  • Shenzhen Geno-immune Medical Institute

    Shenzhen, Guangdong, 518000, China

More trials for these conditions

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