Clinical trial · Interventional
A Study of SHR-A1912 for Injection in Patients With B Cell Lymphomas
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma
NCT05113069CI-TRIAL-00072019unknownPhase 1ClinicalTrials.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)
To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.
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 Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1912 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- SHR-A1912
- interventionNames
- Drug: SHR-A1912
Primary outcomes (4)
- measure
- Adverse Events
- timeFrame
- 21 Days after the 1st dosing (first cycle)
- measure
- Dose Limited Toxicity (DLT)
- timeFrame
- 21 Days (first cycle)
- measure
- Maximum tolerable dose (MTD)
- timeFrame
- 21 Days (first cycle)
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, male or female; 2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1; 3. Life expectancy \>12 weeks; 4. Histologically or cytologically confirmed B cell lymphoma; 5. Relapsed and/or refractory disease after at least 1 prior treatment regimen; 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 (no need for dose escalation stage). 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.