Actively Recruiting
Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma in a Phase II Clinical Study
Led by Sun Yat-sen University · Updated on 2026-01-21
30
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
Fifth Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Relmacabtagene Autoleucel and Sintilimab to treat adults with relapsed or refractory B-cell lymphoma, including types such as diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. This phase II clinical trial aims to assess the treatment's safety and effectiveness, focusing on the complete response rate three months after treatment. The study is sponsored by Sun Yat-sen University and involves participants aged 18 to 70 years with confirmed CD19-positive lymphoma. Participants will first undergo lymphodepletion therapy using intravenous fludarabine and cyclophosphamide over three days to prepare the body for the cellular therapy. Relmacabtagene Autoleucel, an investigational cell therapy, will then be infused intravenously between two and seven days after lymphodepletion. Starting 28 days after this infusion, patients will receive intravenous Sintilimab every three weeks for up to one year or until disease progression or intolerable side effects occur. During the study, participants will be closely monitored through various assessments, including evaluation of response to treatment at three months and ongoing follow-up for up to two years to track disease-free survival, progression-free survival, overall survival, and any adverse events. Researchers will also measure the objective response rate up to one year after infusion. Safety and tolerability will be assessed throughout the trial. Participants can expect regular visits and evaluations to closely observe their condition and treatment effects.
CONDITIONS
Brief Title
Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The patient must be aware of and voluntarily sign the informed consent form (ICF).
- Aged between 18 and 70 years, both male and female.
- Pathologically diagnosed with diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma, with confirmed CD19 positivity.
- Willing to receive regorafenib and sintilimab treatment and deemed suitable by the investigator.
- Relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma.
- At least one measurable or evaluable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival of at least 3 months.
- Adequate function of heart, lungs, liver, kidneys, and other organs.
You will not qualify if you...
- History of another malignancy not in complete remission for at least 2 years, except certain treated cancers.
- Active hepatitis B infection unless HBV-DNA is below reference level.
- Infection with hepatitis C, HIV, or syphilis.
- Uncontrolled systemic fungal, bacterial, viral, or other infections.
- Acute or chronic graft-versus-host disease.
- Known allergy to any study drug or excipient.
- Significant central nervous system disease or symptoms, including epilepsy, seizures, paralysis, stroke, dementia, or psychiatric illness.
- Pregnant or breastfeeding women, or women of childbearing age not using contraception.
- Mentally ill individuals or those unable to provide informed consent.
- Investigator deems patient unsuitable due to medical, psychological, familial, social, or geographical reasons.
- Previous CAR-T cell therapy or other gene-modified T-cell treatments.
- Previous CD19-targeted therapy.
- Previous allogeneic hematopoietic stem cell transplantation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide for 3 days, followed by a reinfusion of Relmacabtagene Autoleucel 2 to 7 days later. Starting on Day 28 after reinfusion, participants receive Sintilimab intravenously every 3 weeks until disease progression, intolerable toxicity, or up to 1 year.
Regular visits every 3 weeks for Sintilimab infusion starting Day 28 after reinfusion
Trial Site Locations
Total: 3 locations
1
Sun Yat-sen Universitiy Cancer Center
Guangzhou, China, 51000
Actively Recruiting
2
Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510060
Not Yet Recruiting
3
Guangzhou overseas Chinese hospital
Guangzhou, China, 510632
Not Yet Recruiting
Research Team
Q
Qingqing Cai, MD. PhD
Y
Yi Xia, MD. PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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