Clinical trial · Interventional
A Safety Study of SGN-CD19B in Patients With B-cell Non-Hodgkin Lymphoma
A Phase 1, Open-label, Dose-escalation Study of SGN-CD19B in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
- 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 will examine the safety profile of SGN-CD19B administered as a single agent. The main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of SGN-CD19B in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) subtypes of diffuse large B-cell lymphoma (DLBCL) and Grade 3 follicular lymphoma (FL3). Additionally, the pharmacokinetic profile and antitumor activity of SGN-CD19B will be assessed.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Grade 3 Follicular Lymphoma | Grade 3 Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGN-CD19B | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SGN-CD19B
- interventionNames
- Drug: SGN-CD19B
Primary outcomes (2)
- measure
- Incidence of adverse events
- timeFrame
- Through 1 month following last dose
- measure
- Incidence of laboratory abnormalities
- timeFrame
- Through 1 month following last dose
Secondary outcomes (5)
- measure
- Blood concentrations of SGN-CD19B
- timeFrame
- Through 3 weeks after dosing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed, refractory, or progressive disease following at least 2 prior systemic therapies * Measurable disease * Eastern Cooperative Oncology Group status of 0 or 1 * Adequate baseline renal and hepatic function Exclusion Criteria: * Prior treatment with CD19 directed agents unless CD19 expression is confirmed after completion of CD19-directed treatment * Known HIV, active hepatitis B or active hepatitis C infection * Prior allogeneic stem cell transplant * Inadequate lung function * Anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment
References
Publications (1)
- DERIVEDRyan MC, Palanca-Wessels MC, Schimpf B, Gordon KA, Kostner H, Meyer B, Yu C, Van Epps HA, Benjamin D. Therapeutic potential of SGN-CD19B, a PBD-based anti-CD19 drug conjugate, for treatment of B-cell malignancies. Blood. 2017 Nov 2;130(18):2018-2026. doi: 10.1182/blood-2017-04-779389. Epub 2017 Sep 13. PMID 28903943