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New 'Sandwich' strategy aims to stop leukemia relapse

NCT ID NCT05470777

Disease control Sponsor: The First Affiliated Hospital of Soochow University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests a new treatment plan for adults with B-cell acute lymphoblastic leukemia (B-ALL) who cannot or choose not to have a donor stem cell transplant. The approach uses a 'sandwich' strategy: first, patients receive two types of CAR T-cells (targeting CD22 and CD19), then their own stem cells are collected and returned after high-dose chemotherapy, followed by another round of CAR T-cells. The goal is to see if this combination is safe and reduces the risk of the cancer coming back. The trial involves 37 participants and is currently active but no longer recruiting.

What this could mean

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

Active substance
CD22/CD19 CAR T-cells and autologous stem cell transplant
What this could lead to
If successful, this approach could lower the chance of leukemia returning after initial treatment, offering a longer period without disease.
What could go wrong
This is a small, early-phase trial with only 37 participants, so results may not apply to everyone. There are risks from CAR T therapy and stem cell transplant, including severe side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 37 people

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

Started

Jan 2020

Expected to finish

Jul 2039

An estimate. End dates often move.

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

15 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: * subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT. * positive expression of CD19 and CD22 in peripheral blood or bone marrow primary cells detected by flow cytometry. * cardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation \> 91% without oxygenation. * subjects aged 15-65 years (including 15 and 65 years), regardless of gender. * T-cell amplification test pass. * expected survival \> 3 months. Exclusion Criteria: * patients with recurrence of only isolated extramedullary lesions. * combination of other malignant tumors. * previously treated with anti-CD19 or/and CD22 or/and CD3 therapies. * immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent. * uncontrolled active infections. * HIV infection. * active hepatitis B or hepatitis C infection. * history of severe tachyphylaxis to aminoglycoside antibiotics. * history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.

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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

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

More trials for these conditions

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