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Closed (no longer recruiting)Last updated: 9 January 2024

GO29781 (BiTE): This phase I trial is evaluating the safety and effectiveness of an investigational therapy (BTCT4465A) alone and in combination with an immunotherapy drug (Atezolizumab) in patients with B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukaemia who have got worse or not responded to treatmentAn Open-Label, Multicenter, Phase I/IB Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Clinical summary

Summary

This is trial includes a does escalation and expansion stage. In the dose escalation stage, patients will receive BTCT4465A (Mosunetuzumab) via intravenous (IV) infusion or subcutaneous (SC) injection as a single-agent or in combination with Atezolizumab. This stage will inform the recommended dose in the dose expansion stage of the study.

Conditions

This trial is treating patients with B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukaemia.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

GO29781 (BiTE)

More information

Trial Identifiers

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Trial sponsor

Genentech

Scientific Title

An Open-Label, Multicenter, Phase I/IB Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after 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

  • Pregnant or lactating women
  • Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
  • Treatment with radiotherapy within 2 weeks prior to the first BTCT4465A (Mosunetuzumab) administration
  • Systemic immunosuppressive medication within 2 weeks prior to study drug
  • Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
  • Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia
  • 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)
  • Receipt of a live attenuated vaccine within 4 weeks prior to study drug
  • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first BTCT4465A (Mosunetuzumab) administration

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Message

Clinical trials have complex eligibility criteria.

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