Clinical trial · Interventional
Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrent Replased/Refractory Mature B Cell Neoplasmstumor
Phase 1 Study to Evaluate the Tolerance and Pharmacokinetics of SHR1459 in Patients With Recurrentreplased/Refractory Mature B Cell Neoplasms Tumor
NCT03664297CI-TRIAL-00062150unknownPhase 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)
SHR1459 is a selective small molecule BTK inhibitor developed by Jiangsu Hengrui medicine Limited, by inhibiting the phosphorylation of BTK and down regulation of BCR signal transduction pathway, And then selectively inhibit the proliferation and migration of B cell tumor.
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 |
|---|---|---|---|
| Mature B Cell Neoplasms | Mature B-Cell Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR1459 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR1459
- description
- Oral administration, once a day, 28 days for a cycle, until the disease progression or the intolerable toxicity occurs.
- interventionNames
- Drug: SHR1459
Primary outcomes (2)
- measure
- Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability])
- timeFrame
- through study completion, an average of about 6 months
- description
- The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of SHR1459 will be assessed
- measure
- Recommended phase 2 dose (RP2D)
- timeFrame
- 28 days since the date of first dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG Performance Status \[PS\] score must be 0 or 1; * Life expectancy ≥ 12 weeks; * Mature B cell eoplasmss with histological or cytological diagnosis, including diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) , chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL), Mantle cell lymphoma (MCL), Marginal zone lymphoma (MZL) and waldenstrom macroglobulinemia (WM); * The function of bone marrow is basically normal; * Renal function is basically normal; * Hepatic function is basically normal. Exclusion Criteria: * Had received treatment with the compound of the same mechanism (BTK inhibitor); * With infiltration of lymphoma central nervous system; * Received autologous stem cell transplantation within 60 days before signing the informed consent, received allogeneic stem cell transplantation in 90 days (after allogeneic stem cell transplantation, if graft-versus-host disease appeared, it must be ≤ level 1, and if there was no prohibited medication, the screening could be performed);
References
Publications (0)
Data not yet available
No reference posted for this study.