Actively Recruiting
Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma
Led by Sun Yat-sen University · Updated on 2026-01-21
30
Participants Needed
3
Research Sites
95 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
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma
CONDITIONS
Official Title
Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must voluntarily sign the informed consent form
- Aged between 18 and 70 years
- Diagnosed with diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma with CD19 positivity confirmed
- Willing and suitable to receive Relmacabtagene Autoleucel and Sintilimab treatment
- Relapsed or refractory lymphoma
- At least one measurable or evaluable lesion
- ECOG performance status of 0 to 2
- Expected survival of at least 3 months
- Adequate heart, lung, liver, kidney, and other organ function
You will not qualify if you...
- Another cancer not in complete remission for at least 2 years, except certain low-risk or treated cancers
- Active Hepatitis B infection with positive surface antigen or core antibody and high HBV-DNA levels
- Hepatitis C, HIV, or syphilis infection
- Uncontrolled systemic infections
- Acute or chronic graft-versus-host disease
- Allergy to study drugs or ingredients
- Serious central nervous system diseases or symptoms
- Pregnant or breastfeeding women or women not willing to use contraception
- Mental illness or inability to provide informed consent
- Deemed unsuitable by investigator due to medical, psychological, social, or compliance reasons
- Prior CAR-T or gene-modified T-cell therapy
- Prior CD19-targeted therapy
- Prior allogeneic hematopoietic stem cell transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Y
Yi Xia, MD. PhD
CONTACT
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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