Clinical trial · Interventional
A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma
A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma
NCT06104553CI-TRIAL-00072566unknownPhase 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 study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's 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 |
|---|---|---|---|
| B-cell Non-Hodgkin's Lymphoma | B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1912; R-Chemo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-A1912 combined with R-Chemo (Phase 1b)
- interventionNames
- Drug: SHR-A1912; R-Chemo
- type
- EXPERIMENTAL
- label
- SHR-A1912 combined with R-Chemo (Phase 2)
- interventionNames
- Drug: SHR-A1912; R-Chemo
Primary outcomes (3)
- measure
- Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy
- timeFrame
- The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months
- measure
- Phase 1b: Incidence and severity of AE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age greater than or equal to18 years old; 2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1; 3. Life expectancy \>3 months; 4. Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma; 5. Previous systematic anti-tumor therapy should meet the following requirements: 1) Relapsed and/or refractory disease after at least one (≥ 1) line of prior systemic therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort). 6. At least one measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as \> 1.0 cm in its longest diameter. Exclusion Criteria: 1. Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment; 2. History of recent major surgery or severe trauma within 4 weeks before the first study treatment; 3. Received anti-tumour treatment within 2 weeks before the first study treatment; 4. Central nervous system (CNS) infiltration; 5. Active infection with HBV or HCV; 6. History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis; 7. Active infection or unexplained fever\>38.5℃; 8. History of severe cardiovascular disease.
References
Publications (0)
Data not yet available
No reference posted for this study.