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Double attack on blood cancer: stem cell transplant plus CAR-T shows promise

NCT ID NCT07236151

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new approach for adults with a tough-to-treat type of blood cancer called large B-cell lymphoma that had returned or not responded to prior treatment. Participants first received a stem cell transplant using their own cells, followed by infusions of two types of engineered immune cells (CAR-T cells) targeting CD19 and CD22. The goal was to see if this combination could improve the number of patients whose cancer completely disappeared, while monitoring side effects. The trial involved 23 participants and has been completed.

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

23 people

The number who actually took part.

Started

Feb 2020

Finished

Apr 2025

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 to 70 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. Patients with relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy. \*\[Note: LBCL includes: diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS); diffuse large B-cell lymphoma transformed from follicular lymphoma (FL-DLBCL); grade 3b follicular lymphoma (FL); primary mediastinal large B-cell lymphoma (PMBCL); high-grade B-cell lymphoma with rearrangements of MYC and BCL-2 and/or BCL-6 (double-hit/triple-hit lymphoma, DHL/THL)\].\* 2. Age Restriction: Individuals must be 18 to 70 years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 4. Presence of at least one measurable target lesion. \*\[Note: A target lesion is defined as ≥1 lesion with a longest diameter (LD) \>1.5 cm and a longest perpendicular diameter (LPD) ≥1.0 cm, as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).\]\* 5. Adequate organ function, defined as: * Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; * Creatinine clearance ≥30 mL/min; * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN). 6. Adequate hematopoietic function, defined as: * Platelet count ≥45 ×10⁹/L; * Hemoglobin ≥8.0 g/dL; * Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L. 7. Life expectancy ≥3 months. 8. For women of childbearing potential, a negative pregnancy test is required. Both male and female patients must agree to use effective contraception during treatment and for 1 year thereafter. 9. Willingness to provide written informed consent. Exclusion Criteria: 1. Prior allogeneic hematopoietic stem cell transplantation or CAR-T cell therapy. 2. Use of immunosuppressive agents or systemic corticosteroids (equivalent to \>10 mg prednisone daily) within 2 weeks prior to leukapheresis, or requirement for continued use after enrollment. 3. Active hepatitis B (HBsAg positive with detectable HBV DNA) or hepatitis C (anti-HCV positive with detectable HCV RNA) infection at screening. 4. Uncontrolled active infection requiring intravenous antimicrobial therapy. 5. History of other malignancies within 2 years prior to enrollment (except adequately treated basal cell carcinoma of skin, squamous cell carcinoma of skin, or carcinoma in situ). 6. Significant comorbidities that may compromise study participation or patient safety, including: * Severe cardiovascular disease (NYHA Class III/IV heart failure, myocardial infarction within 6 months, unstable arrhythmias, or angina) * Severe pulmonary dysfunction (FEV1 or DLCO ≤50% predicted, or requiring supplemental oxygen) 7. HIV infection (positive serology with detectable viral load). 8. Pregnancy, lactation, or unwillingness to use effective contraception. 9. Any condition that in the investigator's judgment would preclude safe participation.

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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.

Contacts and locations

Locations

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000, China

More trials for these conditions

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