Actively Recruiting
Enhancing CAR-T Cell Therapy Efficacy in B-cell Lymphoma Via Chidamide and PD-1 Inhibitor Combination.
Led by Daihong Liu · Updated on 2026-03-24
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
B-cell non-Hodgkin lymphoma (B-NHL) is one of the most common malignancies in China, with approximately 100,000 new cases diagnosed annually. Although immunochemotherapy, novel small-molecule targeted agents, and hematopoietic stem cell transplantation have significantly improved outcomes for patients with B-cell malignancies, nearly half of patients still experience drug resistance and relapse. In high-risk aggressive B-cell lymphoma, the 5-year survival rate remains around 50%. Previous clinical guidelines recommended autologous hematopoietic stem cell transplantation as first-line consolidation therapy for high-risk patients; however, multiple studies have demonstrated that even after autologous transplantation, nearly half of these patients relapse and succumb to the disease. Chimeric antigen receptor T (CAR-T) cell therapy has achieved objective response rates of approximately 50% in relapsed/refractory lymphoma, particularly in B-cell subtypes. Nevertheless, limitations such as tumor immune antigen escape, immunosuppressive effects of the tumor microenvironment (TME) on CAR-T cells, and T-cell exhaustion continue to restrict the durability and efficacy of CAR-T-mediated cytotoxicity. This study evaluates the incorporation of chidamide (an HDAC inhibitor) combined with a PD-1 inhibitor as maintenance therapy following CAR-T cell immunotherapy in patients with relapsed/refractory high-risk aggressive B-cell lymphoma. By implementing an "early intervention" strategy-prompt administration of CAR-T cell therapy after induction treatment for relapsed/refractory high-risk aggressive B-cell lymphoma-and subsequent maintenance with chidamide plus a PD-1 inhibitor, the approach aims to reduce relapse rates and improve overall survival. These strategies are intended to address the current unmet clinical need for improved outcomes in relapsed/refractory high-risk aggressive B-cell lymphoma, where prognosis remains poor despite existing therapies.
CONDITIONS
Official Title
Enhancing CAR-T Cell Therapy Efficacy in B-cell Lymphoma Via Chidamide and PD-1 Inhibitor Combination.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed CD19 and/or CD22-positive large B-cell lymphoma (LBCL) including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), with partial response after induction therapy or complete response but with high-risk features at diagnosis
- Presence of high-risk features at diagnosis such as double-hit/triple-hit lymphoma, 11q aberration, high International Prognostic Index (IPI) scores, CD5 positivity, dual MYC and BCL2 expression, TP53 mutation, molecular subtypes MCD or N1, or relapsed/refractory disease meeting specified criteria
- Age between 18 and 85 years, male or female
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Expected survival longer than 3 months from consent
- Hemoglobin level at least 60 g/L (transfusion allowed)
- Absolute neutrophil count at least 1,000/µL and platelet count at least 45,000/µL
- Adequate liver, kidney, heart, and lung function based on specified laboratory and clinical measures
You will not qualify if you...
- Prior treatment with any CAR-T or genetically modified T-cell therapy
- History of severe allergic reactions to aminoglycoside antibiotics or required medications including biologics
- Known HIV infection, active hepatitis B infection, or uncontrolled systemic infections requiring IV antibiotics
- Significant liver or kidney impairment beyond specified thresholds
- Recent serious cardiovascular events or unstable heart conditions within the past 12 months
- Any other serious medical condition that may interfere with treatment or increase risk
- Pregnant or breastfeeding women
- Unlikely to comply with study procedures or follow-up
- History of other cancers unless disease-free for at least 3 years (except certain skin and cervical cancers)
- Receipt of live vaccine within 6 weeks before preconditioning
- Major surgery within 14 days before treatment or planned during the study
- Any other serious physical, psychiatric illness, or lab abnormality that may pose risk or interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
L
Li-Ping Dou, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here