Relapsed/Refractory Large B-cell Lymphoma (LBCL)Phase 2NCT07613788
Rimegepant Plus Glofitamab and CD19 CAR-T Therapy in R/R LBCL
A Phase 2 study testing Rimegepant, Glofitamab and Obinutuzumab in people with Relapsed/Refractory Large B-cell Lymphoma (LBCL), run by Ruijin Hospital at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed/refractory large B-cell lymphoma. Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Large B-cell Lymphoma (LBCL)
- What is being tested?
- Rimegepant, Glofitamab and Obinutuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2026to Apr 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200020
Weili Zhao, 64370045, zwl_trial@163.com
About this study
Official title: A Study to Evaluate the Efficacy and Safety of Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma
This study is designed to evaluate the efficacy and safety of rimegepant in combination with glofitamab and CD19 CAR-T cell therapy in patients with high-risk relapsed/refractory large B-cell lymphoma. Eligible patients will be randomized to receive glofitamab plus CD19 CAR-T cell therapy with or without rimegepant. The primary endpoint is complete response rate at 6 months after CAR-T cell infusion.
- Being tested
- Rimegepant, Glofitamab, Obinutuzumab, CD19 CAR-T Cell Therapy, Fludarabine
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimegepantDrug
Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion.
GlofitamabDrug
Glofitamab will be administered intravenously with step-up dosing. Participants will receive 2.5 mg on Cycle 1 Day 8, 10 mg on Cycle 1 Day 15, and 30 mg on Cycle 2 Day 1. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation at 30 mg on Day 1 of each 21-day cycle for four cycles.
ObinutuzumabDrug
Obinutuzumab will be administered intravenously at 1000 mg on Cycle 1 Day 1 as pretreatment before glofitamab.
CD19 CAR-T Cell TherapyBiological
Participants will receive CD19-directed CAR-T cell therapy after lymphodepleting chemotherapy. The specific CAR-T product and dose will be determined according to the approved product label, institutional standard practice, and investigator discretion.
FludarabineDrug
Fludarabine will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
CyclophosphamideDrug
Cyclophosphamide will be administered as part of lymphodepleting chemotherapy before CD19 CAR-T cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant Plus Glofitamab and CD19 CAR-T Cell Therapy | Experimental | Participants will receive rimegepant in combination with glofitamab and CD19 CAR-T cell therapy. Rimegepant will be administered orally at 75 mg every other day from the first day of lymphodepleting chemotherapy until Day 90 after CAR-T cell infusion. Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol. Receives: Drug: Rimegepant; Drug: Glofitamab; Drug: Obinutuzumab; Biological: CD19 CAR-T Cell Therapy; Drug: Fludarabine; Drug: Cyclophosphamide |
| Glofitamab Plus CD19 CAR-T Cell Therapy | Active comparator | Participants will receive glofitamab in combination with CD19 CAR-T cell therapy. Glofitamab will be given with obinutuzumab pretreatment and step-up dosing, followed by CD19 CAR-T cell therapy after lymphodepleting chemotherapy. Participants with CR, PR, or SD after CAR-T cell infusion may continue glofitamab consolidation according to the study protocol. Receives: Drug: Glofitamab; Drug: Obinutuzumab; Biological: CD19 CAR-T Cell Therapy; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response Rate at 6 Months
Complete response rate at 6 months is defined as the proportion of participants who achieve complete response at 6 months after CAR-T cell infusion.
Measured: 6 months after CAR-T cell infusion
Secondary outcomes (7)
Objective Response Rate
Objective response rate is defined as the proportion of participants who achieve complete response or partial response.
Measured: Up to 24 months
Complete Response Rate at Day 28
Complete response rate at Day 28 is defined as the proportion of participants who achieve complete response at Day 28 after CAR-T cell infusion.
Measured: Day 28 after CAR-T cell infusion
Complete Response Rate at 3 Months
Complete response rate at 3 months is defined as the proportion of participants who achieve complete response at 3 months after CAR-T cell infusion.
Measured: 3 months after CAR-T cell infusion
Progression-Free Survival
Progression-free survival is defined as the time from randomization to disease progression or death from any cause, whichever occurs first.
Measured: Up to 24 months
Duration of Response
Duration of response is defined as the time from the first documented response to disease progression or death from any cause, whichever occurs first.
Measured: Up to 24 months
Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
Measured: Up to 24 months
Adverse Events
Incidence and severity of adverse events will be assessed throughout the study.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startMay 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Large B-cell Lymphoma (LBCL)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613788
- Sponsor's protocol ID
- RIME-CART
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No