Experimental combo therapy for tough lymphoma shows promise but trial halted early
NCT ID NCT06381830
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested a two-step treatment for patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. First, patients received a stem cell transplant using their own cells, followed by an infusion of CAR-T cells (a type of immune cell therapy). The goal was to see if this combination could improve response rates and delay disease progression. Only 8 patients were enrolled before the study was terminated, so the findings are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-T cell therapy and autologous stem cell transplant
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with hard-to-treat B-cell lymphoma who have relapsed after standard therapy.
- What could go wrong
- This was a very small, early-phase trial that was terminated, so results are limited. The approach carries serious risks, including infection and organ damage from the conditioning chemotherapy.
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
-
8 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Apr 2026
- 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 65 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. Age: 18-65 years. 2. Pathological immunohistochemistry or flow cytometry confirmed that R/ R Large B-cell Non-Hodgkin's Lymphoma with measurable (the longest diameter greater than 1.5cm and the longest vertical diameter greater than 1.0cm) lesions. 3. Previously treated with 1 or more lines of therapy. 4. ECOG≤2#. 5. The main organ functions need to meet the following conditions:LVEF≥50%;CCr≥30 ml/min; ALT and AST≤3 times normal range. 6. Hematopoietic function needs to meet the following conditions: platelet count≥45×10\^9/L; hemoglobin≥8.0 g/dL; absolute neutrophil count≥1.0×10\^9/L. 7. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study. 8. Estimated survival time ≥3 months. 9. Voluntary signing of informed consent and good compliance. Exclusion Criteria: 1. Have used immunosuppressants or hormones within 2 weeks prior to apheresis, or have to use immunosuppressants or hormones after signing informed consent. 2. The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control. 3. Active hepatitis B or active hepatitis C. 4. HIV infection. 5. Have received CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation prior to signing the informed consent. 6. Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma). 7. Pregnant or breasting-feeding women. 8. There is evidence of complications or medical conditions that could interfere with the conduct of the study or put patients at serious risk, including but not limited to serious cardiovascular disease. 9. Conditions deemed by the researchers to be inappropriate for 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.
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