Clinical trial · Interventional
A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase II, Single-arm, Open-label, Multicenter Study on the Efficacy of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma
NCT06368167CI-TRIAL-00076075not yet recruitingPhase 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)
The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR2554 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR2554
- interventionNames
- Drug: SHR2554
Primary outcomes (1)
- measure
- Objective response rate (ORR) assessed by independent review committee (IRC)
- timeFrame
- around 1 year
- description
- percentage of patients who achieve completes response(CR) or partial response(PR) in the study
Secondary outcomes (5)
- measure
- ORR assessed by investigator
- timeFrame
- around 1 year
- description
- percentage of patients who achieve CR or PR in the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males or females aged ≥18 years 2. Histologically confirmed follicular lymphoma 3. Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2 4. Life expectancy ≥ 12 weeks 5. Treated with CD20 antibody, refractory to or relapse from prior anti-cancer therapies 6. Have measurable lesions 7. The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures Exclusion Criteria: 1. Have been treated with a compound of the same machanism; 2. Accompanied by central nervous system infiltration; 3. Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation or CAR-T therapy within 90 days; 4. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug 5. Known active infection 6. History of clinically severe cardiovascular diseases 7. Have other malignancies within 5 years prior to screening Pregnant or lactating women 8. The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption. 9. The subject is taking a known medium or strong CYP inducer. 10. Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination
References
Publications (0)
Data not yet available
No reference posted for this study.