BP41072 - Phase I Study in B-Cell Non-Hodgkin's Lymphoma

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, PHASE I STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF RO7227166 (A CD19 TARGETED 4-1BB LIGAND) IN COMBINATION WITH OBINUTUZUMAB AND INCOMBINATION WITH RO7082859 (CD20-TCB) FOLLOWING A PRE-TREATMENT DOSE OF OBINUTUZUMAB ADMINISTERED IN PARTICIPANTS WITH RELAPSED/REFRACTORY B-CELL NON-HODGKIN’S LYMPHOMA

• IRAS ID

  277972

• Contact name

  William Townsend

• Contact email

  William.Townsend@nhs.net

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Eudract number

  2019-000416-28

• Clinicaltrials.gov Identifier

  NCT04077723

• Duration of Study in the UK

  2 years, 8 months, 7 days

• Research summary

  Non-Hodgkin’s lymphoma (NHL) is cancer of the immune system (B-cells and T-cells) and a leading cause of cancer deaths. Despite significant advances in immune-treatments that have extended progression free survival times, current treatment for relapsing NHL requires intense chemotherapy with many side effects. There still remains an unmet medical need, for safer and effective NHL therapies especially in the relapsed setting.

  The purpose of this phase I study (BP41072) is to test the safety and effectiveness of drug RO7227166, when given together with other drugs (either obinutuzumab (Gazyva®, Gazyvaro®) or CD20-TCB) at different doses and to determine the optimal dose of RO7227166 for participants with NHL.

  This study aims to investigate whether this combination of drugs is safe and effective in the treatment of NHL. It is thought that RO7227166 may enhance the activity of obinutuzumab or CD20-TCB.

  The study is made up of three different parts and participants can participate in one part only:
  • Part I: Dose-escalation (Combination of RO7227166 and Obinutuzumab)
  • Part II: Dose-escalation (Combination of RO7227166 and CD20-TCB)
  • Part III: Dose Expansion (Combination of RO7227166 and CD20-TCB)

  Approximately 207 participants will take part in the study worldwide and approximately 15 participants from 2 UK hospitals.
  This study will enrol patients with NHL that has recurred (relapsed) or become resistant to previous treatments (refractory) and meet the study eligibility criteria.

  All patients will receive study treatment every 3 weeks unless they discontinue treatment early.

  The maximum duration of the study for each participant will be up to 24 months in Part I (excluding follow-up until progression and long term follow-up) and up to 15 months in Part II and Part III (excluding follow-up until progression and long term follow up).

  The study is sponsored by F. Hoffman La Roche
  Research Summary; Version Number 1.0, dated 25-Feb-2020

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  20/NE/0092

• Date of REC Opinion

  22 Apr 2020

• REC opinion

  Further Information Favourable Opinion