Testing GB261 for B-Cell Lymphoma and Chronic Lymphocytic Leukemia
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
This study is testing a new treatment called GB261 to see if it can help people with relapsed or hard-to-treat B-cell lymphoma and chronic lymphocytic leukemia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genor Biopharma Co., Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 6 sites (Sydney, New South Wales and 5 other locations) |
| Trial ID | NCT04923048 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, pharmacokinetics, and efficacy of GB261, a bispecific antibody targeting CD20 and CD3, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). It consists of a dose-escalation phase (Phase 1) followed by an expansion phase (Phase 2a) and indication-specific cohorts in Phase 2b. Participants will receive GB261 to assess its therapeutic potential in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates include individuals with CD20+ B-cell NHL or CLL who have relapsed after at least one prior treatment and have no available therapies expected to improve survival.
Not a fit: Patients with certain types of lymphoma, recent systemic therapy, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment alternatives.
How similar studies have performed: Other studies involving bispecific antibodies have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sydney, New South Wales and 5 other locations
- St Vincent's Hospital/The Kinghorn Cancer Centre — Sydney, New South Wales, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Cabrini hospital — Melbourne, The State Of Victoria, Australia (Recruiting)
- Alfred hospital — Melbourne, The State Of Vitoria, Australia (Recruiting)
- Peninsula & South Eastern Haematology & Oncology Group — Melbourne, The State Of Vitoria, Australia (Terminated)
- One Clinical Research Pty Ltd — Mount Pleasant, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Xiao Yu, MD
- Email: shawn.yu@genorbio.com
- Phone: 021-60751991
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.