A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL.

  • STATUS
    Recruiting
  • End date
    Jun 28, 2025
  • participants needed
    460
  • sponsor
    Genor Biopharma Co., Ltd.
Updated on 10 August 2022
lymphoma

Summary

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.

Details
Condition B Cell NHL, CLL
Treatment GB261
Clinical Study IdentifierNCT04923048
SponsorGenor Biopharma Co., Ltd.
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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
Adequate hepatic, hematologic, and renal function

Exclusion Criteria

Burkitt lymphoma, lymphoplasmacytic lymphoma or B lymphoblastic leukemia
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
History of auto-SCT or CAR-T therapy in the past 180 days and/or with any of protocol specified conditions
Prior allo-SCT or allogeneic CAR-T
Prior solid organ transplantation
Autoimmune disease with the exceptions specified in the protocol
History of central nervous system(CNS) lymphoma or other CNS disease
Significant cardiovascular or pulmonary disease
Hepatitis B or C or human immunodeficiency virus (HIV)
Pregnant or lactating or intending to become pregnant during the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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