Double-Barreled attack: stem cell transplant plus CAR-T shows promise for Hard-to-Treat lymphoma
NCT ID NCT04923789
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study tested a two-step approach for people with relapsed or refractory B-cell non-Hodgkin's lymphoma. First, patients received a stem cell transplant using their own cells, followed by CAR-T cell therapy. The goal was to see if this combination could improve how long patients live without their cancer getting worse. The trial enrolled 100 adults aged 18 to 65 and tracked outcomes like survival and side effects over 18 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous hematopoietic stem cell transplant followed by chimeric antigen receptor T (CAR-T) cell therapy
- What this could lead to
- If successful, this combination could offer a more effective treatment option for patients with hard-to-treat B-cell lymphoma that has come back or not responded to standard therapy.
- What could go wrong
- This is a single-center, non-randomized study with no control group, so results may not be generalizable. Both stem cell transplant and CAR-T therapy carry significant risks, including severe side effects like infection, organ damage, and immune reactions.
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.
- Participants
-
100 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
-
Mar 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.
Who is studied
The total number of patients was 60.
- Ages
-
18 to 65 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 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-NHL with extrinsic involvement. 2. Age ≥ 18 years and ≤ 65 years. 3. Measurable disease of at least 15mm(node)/10mm(extranodal) 4. Meet any of the following conditions :1. After 4 courses of standard first-line treatment or 2 courses of treatment with more than two lines, the lesions decreased by less than 50%;2 B-NHL with disease progression after first-line or induction treatment;3. Relapsed B-NHL within 12 months after ASCT;4. After standard chemotherapy or hematopoietic stem cell transplantation, the size of any new lesions or the previously involved site which had achieved complete remission increased by 50% or more. 5. Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2\*10\^6/kg. 6. Estimated survival time ≥3 months Exclusion Criteria: 1. Having received allogeneic hematopoietic stem cell transplantation previously; 2. HIV-positive; 3. Active hepatitis B or C infection; 4. Previous history of other malignant tumors. Excluded: Patients who had cured basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix at any time prior to the study; Patients with disease-free survival ≥5 years who had been cured by surgery only without further treatment for the other tumors listed above can be included in the study. 5. Patients with cardiac insufficiency:ejection fraction (EF) \< 30%, NYHA standard, grade II or above 6. Patients with liver and renal insufficiency: Serum Direct Bilirubin (SB) ≥2mg/ dL (34.2μmol/L), Aspartate Aminotransferase(AST) \> 2.5 times the up, Serum Creatinine (SCR) \> 2.5mg/ dL (221μmol/L) 7. Female patients who are pregnant, preparing to become pregnant or lactating. 8. The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Refractory non-Hodgkin lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- New combo therapy shows promise for tough lymphoma cases
- Promising CAR-T therapy trial for lymphoma withdrawn before it began
- Experimental combo therapy for tough lymphoma shows promise but trial halted early
- Supercharged immune cells take on tough lymphoma
- New combo tackles tough lymphoma
- Triple-Target CAR T-Cells offer new hope for tough blood cancers