Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Simpler CAR-T therapy tested for tough blood cancers

NCT ID NCT07383233

Disease control Sponsor: Qi deng 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests a new CAR-T cell therapy that is made inside the body, avoiding the complex and costly lab process. It targets two proteins (CD19 and BAFF-R) on cancer cells in people with relapsed or hard-to-treat B-cell leukemia or lymphoma. The main goals are to check safety and see if the cancer shrinks or disappears.

What this could mean

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

Active substance
CD19/BAFF-R in vivo CAR-T cells
What this could lead to
If successful, this could lead to a simpler, cheaper CAR-T therapy that is easier for patients to access, offering a new option for hard-to-treat blood cancers.
What could go wrong
This is a very early Phase 1 trial with only 18 participants, so safety and effectiveness are not yet proven. The therapy may cause serious immune reactions or fail to control the cancer.

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

About 18 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 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

14 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: Subjects must meet all of the following criteria: * The diagnosis was confirmed as B-cell acute leukemia/malignant lymphoma. Requirements for prior treatment: Patients with B-cell acute leukemia/malignant lymphoma who failed to achieve PR after first-line therapy or experienced relapse within 12 months after first-line therapy; or those with relapsed/refractory disease after second-line therapy (a standardized chemotherapy regimen plus salvage chemotherapy). During screening, the patient was in a state of disease recurrence or refractory condition: Acute B-cell leukemia: a) Relapse definition: The presence of blast cells (proportion\>5%) in peripheral blood or bone marrow after achieving complete remission with a standardized treatment regimen (including hematopoietic stem cell transplantation), or the development of extramedullary disease; b) Refractory definition: Failure to achieve complete remission after at least two courses of standardized induction therapy. B-cell lymphoma: a) Definition of relapse: PD after achieving remission (including partial response (PR) or complete response (CR)) following adequate treatment; b) Definition of refractory: i. No response to the last treatment: PD during/after the last treatment or SD with a duration of less than 6 months; ii. Relapse or progression after ASCT, including: relapse or PD within 12 months after ASCT, and no response to the last treatment (SD or PD) if salvage therapy is administered. * The subject's predicted survival time is not less than three months. * Tumor cells confirmed to be CD19/BAFFR positive by Flow Cytometry (FCM) or Immunohistochemistry. * Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed/refractory B-cell lymphoma (B-LY) who have at least one evaluable lesion. * Age 14-75 years (inclusive), both genders eligible. * ECOG performance status ≤ 3. * HGB≥70g/L(transfusion permitted). * The functions of vital organs need to meet the following conditions: ①Creatinine ≤ 2.5 × ULN or Cockcroft-Gault creatinine clearance \> 50 ml/min (excluding decreased serum creatinine clearance due to lymphoma mass compression), Combination with hemodialysis treatment is permitted. ②LVEF≥50%,② Oxygen saturation ≥90%,③ SCr≤2.5ULN,④ALT and AST≤3ULN,TBil≤2ULN. In the investigator's judgment, if organ dysfunction is associated with the current disease, the enrollment decision will be made by the investigator. * Subjects intending to conceive must agree to use contraception prior to study enrollment and for six months post-study. In the event of pregnancy or suspected pregnancy, they should promptly notify the investigator. * The subject or guardian understands and signs the Informed Consent Form (ICF). Exclusion Criteria: Any of the following conditions will not be eligible for enrolment: * Severe heart failure with left ventricular ejection fraction (LVEF) \< 50%. * History of severe pulmonary function impairment. * Concurrent other progressive malignant tumors. * Concurrent severe infection that cannot be effectively controlled. * Concurrent severe autoimmune disease or congenital immunodeficiency. * Active hepatitis (hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive with HBV DNA copy number greater than the upper limit of normal at the study center; Anti-HCV positive with HCV-RNA copy number greater than the upper limit of normal at the study center). * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection. * History of severe allergy to biological products (including antibiotics). * Received inactivated vaccines such as influenza vaccine, COVID-19 vaccine within 4 weeks prior to screening, or received live attenuated vaccines (such as measles, varicella vaccines) within 8 weeks. * Patients with other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, and patients considered unsuitable for this study by the investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

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