Migraine drug may boost CAR-T therapy in tough lymphoma
NCT ID NCT07613788
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tests whether adding the migraine drug rimegepant to a standard CAR-T cell therapy and another immunotherapy (glofitamab) can improve outcomes for people with high-risk relapsed or refractory large B-cell lymphoma. About 100 adults will be randomly assigned to receive the combination with or without rimegepant. The main goal is to see how many patients achieve a complete response (no detectable cancer) at 6 months after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rimegepant, glofitamab, obinutuzumab, and CD19 CAR-T cells
- What this could lead to
- If successful, this combination could improve the chance of complete remission for patients with hard-to-treat lymphoma.
- What could go wrong
- This is an early Phase 2 trial with only 100 participants. The added benefit of rimegepant is unproven, and side effects from the combination may be significant.
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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
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: * Able to understand and voluntarily sign the written informed consent form. * Age 18 years or older. * Histologically confirmed large B-cell lymphoma with CD19 and CD20 expression. * Relapsed or refractory disease after at least one prior line of systemic therapy. * Prior treatment must have included an anthracycline-containing chemotherapy regimen and an anti-CD20 monoclonal antibody. * Considered suitable by the investigator to receive glofitamab and CD19 CAR-T cell therapy. * Presence of at least one high-risk feature, including extranodal involvement, bulky disease, or TP53 abnormality. * ECOG performance status of 0 to 2. * Life expectancy of at least 12 weeks. * Adequate bone marrow, hepatic, renal, pulmonary, and cardiac function as determined by the investigator. * Participants of reproductive potential must agree to use effective contraception during the study period. * Able and willing to comply with the study protocol, in the investigator's judgment. Exclusion Criteria: * History of hypersensitivity to any study treatment or related compounds. * Active or uncontrolled infection requiring systemic treatment. * History of allogeneic hematopoietic stem cell transplantation or organ transplantation. * Uncontrolled or clinically significant viral infection as defined by the protocol. * Known central nervous system involvement by lymphoma or clinically significant central nervous system disease that may interfere with study treatment or safety assessment. * Severe or uncontrolled cardiovascular disease. * Severe autoimmune disease or immune-mediated disease that may interfere with study treatment or safety assessment. * Known or suspected history of hemophagocytic lymphohistiocytosis. * Recent thromboembolic event before screening. * History of another malignancy within 5 years before screening, except adequately treated carcinoma in situ or non-melanoma skin cancer. * Receipt of prohibited anticancer therapy, immunosuppressive therapy, live attenuated vaccine, or other prohibited treatment within the protocol-specified period before enrollment. * Pregnant or breastfeeding women, or participants planning pregnancy during the study period. * Concurrent participation in another interventional clinical trial. * Need for prohibited concomitant medications that cannot be discontinued or substituted. * Any condition that, in the investigator's judgment, makes the participant unsuitable for study treatment or study 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.
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
Shanghai, China, 200020, China
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