Clinical trial · Interventional
Study of Chidamide, Decitabine and Immune Checkpoint Inhibitors in R/R NHL and Advanced Solid Tumors
A PhaseⅠ/Ⅱ Trial of Chidamide,Decitabine and Immune Checkpoint Inhibitors in Relapsed/Refractory Non-Hodgkin Lymphoma and Advanced Solid Tumors
NCT05320640CI-TRIAL-00057692unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I/II trial aims to evaluate safety and efficacy of Chidamide, Decitabine and Immune checkpoint inhibitors in relapsed/refractory Non-Hodgkin Lymphoma and advanced solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Relapsed/Refractory Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chidamide | Drug | — | UNRESOLVED |
| Decitabine | Drug | Decitabine | ALIAS |
| Immune checkpoint inhibitors(anti-PD1/PD-L1/CTLA4 antibodies) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Drug: Chidamide10mg/day, day1-4; 20mg/day, day8, 11, 15, 18. Drug: Decitabine10mg/day, day1-5. Drug: Immune Checkpoint Inhibitors(anti-PD1/PD-L1/CTLA4 antibodies). Physicians will decide which ICIs will be used during treatment. Every 3 weeks.
- interventionNames
- Drug: Chidamide
- Drug: Decitabine
- Drug: Immune checkpoint inhibitors(anti-PD1/PD-L1/CTLA4 antibodies)
Primary outcomes (2)
- measure
- Objective response rate (ORR)
- timeFrame
- 3 years
- description
- The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria (Lugano 2014 criteria) and Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
- measure
- Adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 16 to 80 years of age. 2. ECOG performance of less than 3. 3. Life expectancy of at least 3 months. 4. Histopathological confirmed Non-Hodgkin Lymphoma and solid tumors. 5. Patients are relapsed/refractory Non-Hodgkin Lymphoma with ineligible for autologous hematopoietic stem cell transplantation. 6. The guidelines(ASCO/CSCO)recommend patients to participate in clinical trials. 7. Subjects must have at least one measureable target lesion. 8. Willingness to provide written informed consent for the study. Exclusion Criteria: 1. Active, known or suspected autoimmune diseases. 2. Subjects are being treated with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. 3. History of severe hypersensitive reactions to other monoclonal antibodies. 4. History of allergy or intolerance to study drug components. 5. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. 6. History or concurrent condition of interstitial lung disease of any grade or severely impaired pulmonary function. 7. Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient. 8. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 9. Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented. 10. Vaccination within 30 days of study enrollment. 11. Active bleeding or known hemorrhagic tendency.
References
Publications (0)
Data not yet available
No reference posted for this study.