Double-Barreled attack: CAR-T plus stem cell transplant takes on aggressive lymphoma
NCT ID NCT07538635
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a powerful two-step approach for people with a fast-growing type of lymphoma that has not responded to standard treatments. First, patients receive a CAR-T cell therapy (engineered immune cells) followed by a stem cell transplant with high-dose chemotherapy. The goal is to see if this combination can better control the cancer and improve survival. The trial is currently recruiting 20 adults with high-risk large B-cell lymphoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Axicabtagene ciloleucel (a CAR-T cell therapy) combined with a stem cell transplant
- What this could lead to
- If successful, this combination could offer a more effective way to control aggressive lymphoma that has come back or not responded to standard treatments.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The treatment involves intense chemotherapy and carries risks like severe side effects or the cancer not responding.
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
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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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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- 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 years and older
- 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. Age ≥ 18 years 2. Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (tFL) 3. Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline 4. Meet one of the following clinical high-risk factors or molecular biological high-risk factors: 1. Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months after achieving complete response (CR) with first-line immunochemotherapy; or relapse after autologous hematopoietic stem cell transplantation (ASCT); or central nervous system involvement at the time of disease relapse or progression 2. Molecular biological high-risk factors: TP53 gene mutation; or high-grade B-cell lymphoma (HGBL) with MYC and Bcl-2 rearrangements, with or without Bcl-6 rearrangement 5. ECOG 0 to 2 6. Eligible for high-dose chemotherapy/autologous hematopoietic stem cell transplantation (HDCT/ASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy 7. Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 mg/dL; serum creatinine ≤ 1.5 × ULN, or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 30 mL/min 8. Left ventricular ejection fraction (LVEF) ≥ 40% 9. Life expectancy ≥ 3 months Exclusion Criteria: 1. Patients who have previously received any CD19-targeted therapy 2. Patients with CD19 negativity confirmed by immunohistochemistry (IHC) 3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with or without liver function abnormalities 4. Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases 5. History of human immunodeficiency virus (HIV) infection 6. Pregnant or lactating patients
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhengjiang, 310022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma
- Can AI spot the lymphoma patients who Won't respond?
- Outpatient immunotherapy tested for hard-to-treat lymphomas
- Can an antibody drug boost standard chemotherapy against an aggressive blood cancer?