Clinical trial · Interventional
A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL.
A Phase Ⅰ/Ⅱ, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GB261 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
NCT04923048CI-TRIAL-00066586unknownPhase 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 is a Phase 1/2 study of GB261 in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage(Phase 1), an expansion stage(Phase 2a) and Phase 2b stage where participants will be enrolled into indication-specific cohorts.
Conditions
Conditions (2)
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 NHL | — | UNRESOLVED | — |
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GB261 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GB261
- description
- Participants will receive GB261 via intravenous (IV) infusion as a single agent on Day 1, Day 8 and Day 15 of Cycle 1 and 2 followed by Day 1 of each cycle（21 days per cycle） afterwards until disease progression or other situations specified in the protocol, whichever comes earlier.
- interventionNames
- Biological: GB261
Primary outcomes (4)
- measure
- Maximum Tolerated Dose
- timeFrame
- During Cycle 1 (up to 21 days)
- measure
- Dose Limiting Toxicity
- timeFrame
- During Cycle 1 (up to 21 days)
- measure
- Percentage of participants with adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 2. CD20+ B-cell Non-Hodgkin Lymphoma or CLL who have relapsed or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival 3. Adequate hepatic, hematologic, and renal function Exclusion Criteria: 1. Burkitt lymphoma, lymphoplasmacytic lymphoma or B lymphoblastic leukemia 2. Prior treatment with systemic anti-lymphoma therapy within 4 weeks or five half-lives of the drug (which is shorter) prior to the first GB261 infusion 3. History of auto-SCT or CAR-T therapy in the past 180 days and/or with any of protocol specified conditions 4. Prior allo-SCT or allogeneic CAR-T 5. Prior solid organ transplantation 6. Autoimmune disease with the exceptions specified in the protocol 7. History of central nervous system(CNS) lymphoma or other CNS disease 8. Significant cardiovascular or pulmonary disease 9. Hepatitis B or C or human immunodeficiency virus (HIV) 10. Pregnant or lactating or intending to become pregnant during the study
References
Publications (0)
Data not yet available
No reference posted for this study.