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Double-Barreled attack: stem cell transplant plus CAR-T shows promise for Hard-to-Treat lymphoma

NCT ID NCT04923789

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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