Double punch for lymphoma: stem cell transplant plus CAR-T therapy
NCT ID NCT06365671
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether giving a special immune cell treatment (CAR-T) right after a stem cell transplant can help people with aggressive B-cell lymphoma that has not responded to standard treatments. The trial will enroll 16 people and measure how many achieve complete remission within 3 months. The approach aims to wipe out remaining cancer cells after the transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- relmacabtagene autoleucel (relma-cel), a type of CAR-T cell therapy
- What this could lead to
- If it works, this could offer a new treatment option for people with aggressive B-cell lymphoma that has come back or not responded to standard therapy.
- What could go wrong
- This is a small, early-phase trial with only 16 people, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome and nerve 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
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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 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Apr 2027
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. Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types * diffuse large B-cell lymphoma * high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement * transformed lymphoma * primary mediastinal large B-cell lymphoma * follicular lymphoma (FL) 2. Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen) * Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy * Stable disease (SD) as best response after at least 4 cycles of first-line therapy * Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4) * PR as best response after at least 2 cycles of second-line therapy * Disease relapse ≤12 months after the completion of first-line immunochemotherapy * Relapsed or refractory disease after ≥2 lines of chemotherapy 3. Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Eligible for HDCT/ASCT based on the investigator's assessment and are scheduled to undergo an ASCT sequential CAR-T treatment regimen 6. Adequate renal and hepatic function defined as: * Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN) * Total bilirubin ≤1.5 mg/dL(\<3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma) * Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min 7. Cardiac ejection fraction ≥ 40% 8. Baseline oxygen saturation \> 95% on room air 9. Life expectancy ≥3 months Exclusion Criteria: 1. History of autologous or allogeneic stem cell transplantation 2. Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CAR-T cells infusion. 3. Presence of uncontrolled infection, cardio-cerebrovascular disease,coagulopathy, or connective tissue disease. 4. History of HIV infection 5. Prior chimeric antigen receptor cellular immunotherapy targeting CD19 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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Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITINGShanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Two-Drug combo targets tough Non-Hodgkin's 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?