Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma
NCT ID: NCT07077512
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2025-09-15
2027-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Relmacabtagene Autoleucel As Second-Line Therapy in Adult Patients with Aggressive B-cell NHL
NCT06093841
Axicabtagene Ciloleucel Injection in Patients With Relapsed/Refractory Follicular Lymphoma
NCT06826118
Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
NCT03075553
Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma
NCT04231370
Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
NCT04279379
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Sintilimab treatment: Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.
Primary endpoint: The complete response rate (CRR) at 3 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Relmacabtagene Autoleucel in combination with Sintilimab
Patients with CD19-positive relapsed/refractory B-cell lymphoma will receive Relmacabtagene Autoleucel after lymphodepletion therapy (fludarabine + cyclophosphamide) on Day 1. After Relmacabtagene Autoleucel infusion, sintilimab (200 mg IV) will begin on Day 28, administered every 3 weeks until disease progression or intolerable toxicity, with a maximum duration of 1 year.
Autoleucel (Relmacabtagene Autoleucel)
Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).
Sintilimab (PD-1 inhibitor)
Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autoleucel (Relmacabtagene Autoleucel)
Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).
Sintilimab (PD-1 inhibitor)
Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Aged between 18 and 70 years, both male and female.
3. Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).
4. The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
5. Relapsed/refractory DLBCL, FL, or MCL.
6. At least one measurable or evaluable lesion.
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
8. Expected survival of ≥3 months.
9. Adequate function of the heart, lungs, liver, kidneys, and other organs.
Exclusion Criteria
2. Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.
3. Hepatitis C, HIV, or syphilis infection.
4. Uncontrolled systemic fungal, bacterial, viral, or other infections.
5. Acute or chronic graft-versus-host disease (GVHD).
6. Known hypersensitivity or allergy to any study drug or excipient.
7. Clinically significant central nervous system (CNS) disease or symptoms, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness.
8. Pregnant or breastfeeding women, and women of childbearing age who do not wish to use contraception.
9. Mentally ill individuals or those unable to provide informed consent.
10. The investigator deems the patient unsuitable for the study due to medical, psychological, familial, social, or geographical reasons or an inability to comply with the study protocol.
11. Previous CAR-T cell therapy or other gene-modified T-cell treatments.
12. Previous CD19-targeted therapy.
13. Previous allogeneic hematopoietic stem cell transplantation.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fifth Affiliated Hospital of Guangzhou Medical University
OTHER
Guangzhou Overseas Chinese Hospital,Guangdong
UNKNOWN
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Qingqing Cai
chief physician
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-sen Universitiy Cancer Center
Guangzhou, , China
Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, , China
Guangzhou overseas Chinese hospital
Guangzhou, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B2025-263-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.