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Double punch for lymphoma: stem cell transplant plus CAR-T therapy

NCT ID NCT06365671

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2027

An estimate. End dates often move.

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.

Ages

18 years and older

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-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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, China

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