Engineered immune cells take on philadelphia Chromosome-Positive leukemia

NCT ID NCT07252336

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether specially engineered immune cells (CAR-T cells) can treat adults with a specific, aggressive form of acute lymphoblastic leukemia that has a genetic marker called the Philadelphia chromosome. Fifty newly diagnosed patients will receive an infusion of these cells. The main goal is to see if the treatment can make the cancer disappear at a molecular level.

What this could mean

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

Active substance
CD19/CD22 CAR-T cells
What this could lead to
If successful, this could offer a new treatment option for adults with a hard-to-treat form of leukemia, potentially improving remission rates without standard chemotherapy.
What could go wrong
This is an early Phase 2 trial with only 50 participants, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome or neurological problems.

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 50 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 2028

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

18 years and older

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 ≥ 18 years old, gender not restricted; 2. Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias; 3. Abnormal B cells positive for CD19 and CD22 by immunophenotyping; 4. Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing; 5. Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens; 6. Serum total bilirubin ≤ 51 μmol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal reference range, and serum creatinine ≤ 176.8 μmol/L; 7. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography; 8. Subjects with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation; 9. Estimated survival time ≥ 3 months; 10. ECOG performance status score 0-2; 11. Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion; 12. Subjects voluntarily participate in this study and sign the informed consent form. Exclusion Criteria: * Subjects meeting any of the following exclusion criteria are ineligible for enrollment in this study: 1. Subjects with a history of epilepsy or other central nervous system diseases; 2. Subjects with a prior history of QT interval prolongation or severe cardiac diseases; 3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown); 4. Subjects with untreated active infections; 5. Subjects with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral treatment, or have a detectable HBV viral DNA load; subjects with serological evidence of hepatitis C virus (HCV) infection who have not completed curative treatment or have a detectable HCV viral load; 6. Human immunodeficiency virus (HIV) antibody positive; 7. Syphilis antibody positive; 8. Subjects who have previously received any gene therapy products; 9. Subjects with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment; 10. Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • The first affiliated hospital of medical college of zhejiang university

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

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