OncoMatch/Clinical Trials/NCT07489989
Enhancing CAR-T Cell Therapy Efficacy in B-cell Lymphoma Via Chidamide and PD-1 Inhibitor Combination.
Is NCT07489989 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies CAR-T Cell Therapy + Chidamide and PD-1 Inhibitor Maintenance for relapsed or refractory diffuse large b-cell lymphoma (r/r dlbcl).
Treatment: CAR-T Cell Therapy + Chidamide and PD-1 Inhibitor Maintenance — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 overexpression (positive)
CD19 and/or CD22-positive large B-cell lymphoma
Required: CD22 overexpression (positive)
CD19 and/or CD22-positive large B-cell lymphoma
Allowed: MYC rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements ("double-hit" or "triple-hit") confirmed by fluorescence in situ hybridization (FISH)
Allowed: BCL2 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements ("double-hit" or "triple-hit") confirmed by fluorescence in situ hybridization (FISH)
Allowed: BCL6 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements ("double-hit" or "triple-hit") confirmed by fluorescence in situ hybridization (FISH)
Allowed: CD5 overexpression
CD5 positivity by immunohistochemistry
Allowed: MYC overexpression
Dual expression of MYC and BCL2 by immunohistochemistry (recommended thresholds: MYC ≥ 40% and BCL2 ≥ 50%)
Allowed: BCL2 overexpression
Dual expression of MYC and BCL2 by immunohistochemistry (recommended thresholds: MYC ≥ 40% and BCL2 ≥ 50%)
Allowed: TP53 mutation
TP53 mutation detected by gene sequencing
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: anti-cd20 monoclonal antibody
Must have received: anthracycline-containing combination chemotherapy
Cannot have received: car-t cell therapy
Lab requirements
Blood counts
Hemoglobin ≥60 g/L (transfusion permitted); ANC ≥1,000/μL; platelet count ≥45,000/μL
Kidney function
Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault)
Liver function
Total bilirubin (TBIL) ≤1.5 × ULN (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN
Cardiac function
LVEF ≥50% by ECHO, no pericardial effusion, no clinically significant arrhythmias
Adequate hepatic, renal, cardiac, and pulmonary function, meeting all of the following: TBIL ≤1.5 × ULN (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or CCr ≥60 mL/min; LVEF ≥50% by ECHO, no pericardial effusion, no clinically significant arrhythmias; Baseline oxygen saturation by pulse oximetry >92% on room air; No clinically significant pleural effusion.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07489989 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior car-t cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Does this trial require CD22?
Yes, CD22 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify