Double attack on blood cancer: stem cell transplant plus CAR-T shows promise
NCT ID NCT07236151
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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23 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Apr 2025
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.
- Can a Tumor's DNA reveal the best lymphoma treatment?
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Can engineered immune cells beat tough B-Cell cancers?
- Can engineered immune cells lock in remission for aggressive lymphoma?
- Can a One-Time infusion of Dual-Target CAR-T cells outsmart resistant blood cancers?
- A shot at safer CAR t: early brain protection for lymphoma patients?