A clinical trial to look at how well RO7443904 and glofitamab work (when taken together) to treat people with relapsed or refractory Non-Hodgkin’s lymphoma, and how safe the combination is

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

  • Non-Hodgkin's Lymphoma
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Denmark
  • France
  • Italy
  • United Kingdom
Trial Identifier:

NCT05219513 BP43131

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a first-in human, open-label, Phase 1 dose-escalation study in order to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for intravenous (IV) and/or subcutaneous (SC) dosing schemes of this combination treatment, and to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of this combination treatment in participants with relapsed/refractory B-cell non Hodgkin lymphoma (r/r NHL).

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT05219513 , BP43131 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      The aim of this document is to give people interested in this trial the background, treatment plan, scope of participants who are able to take part, benefits and risks. We recommend that this should be read carefully by potential participants and shared with close family members and caregivers. 

      Why is the BP43131 clinical trial needed?

      Non-Hodgkin’s lymphoma (NHL) comprises a range of diseases such as follicular lymphoma, chronic lymphocytic leukaemia and mantle cell lymphoma. Despite recent treatment advances, NHL is still one of the leading causes of cancer death in both the United States and Europe. There is a demand for new treatment options to improve outcomes for patients with NHL.

      The goal of this clinical trial is to determine how well RO7443904 and glofitamab work (when taken together) to treat people with NHL, and how safe the combination is.  

      How does the BP43131 clinical trial work?

      This clinical trial is recruiting people who have a health condition called Non-Hodgkin’s lymphoma (NHL). People can take part if they have NHL that has returned after successful treatment (relapsed) or has never responded to treatment (refractory).

      The purpose of this clinical trial is to test the safety of RO7443904 when given with glofitamab, and to understand the way the body processes RO7443904.

      How long a participant will be given the clinical trial treatment RO7443904 plus glofitamab for depends on how the participant’s cancer responds to the treatment. Participants will be seen by the clinical trial doctor regularly. These hospital visits will include checks to see how the participant is responding to the treatment and any side effects they may be having. Participants’ total time in the clinical trial will depend on how their disease responds to treatment (could range from one day to more than 11 months). Participants are free to stop trial treatment and leave the clinical trial at any time.

      What are the main endpoints of the BP43131 clinical trial?

      The main clinical trial endpoints (the main results that are measured in the trial to see if the medicine has worked) are the type and number of dose-limiting toxicities (DLTs) and adverse events (AEs). DLTs are treatment side effects that are too severe to allow for dose increases for other participants later in the clinical trial, and AEs are any unexpected medical problems that occur while receiving the treatment. These will be measured from the first dose of treatment until the end of the clinical trial.

      The other clinical trial endpoints are the pharmacokinetic (PK) properties of RO7443904 and the amount of anti-drug antibodies (ADAs) detected within the body. The PK properties of the drug include how a drug enters and moves through the body, while ADAs are an immune response generated by the body in response to a treatment. Both will be assessed from the start until the end of the clinical trial.

      Who can take part in this clinical trial?

      Patients can take part in this trial if they are aged 18 or over, have a body weight of at least 40 kg and have been diagnosed with relapsed or refractory NHL according to certain criteria.

      Patients may not be able to take part in this trial if they are pregnant, become pregnant, or if they are currently breastfeeding. Patients who have received cancer immunotherapy within four weeks prior to the start of the clinical trial will not be able to take part.

      What treatment will participants be given in this clinical trial?

      This clinical trial is split into five parts (Ia, Ib, II, III and IV). During the trial, you will only participate in one of these parts.

      Every participant will receive a single pre-treatment dose of obinutuzumab as an infusion into the vein (intravenous) within seven days prior to Cycle 1, Day 1, regardless of which part of the clinical trial they are assigned to.

      Part Ia: Participants will receive their first dose of glofitamab on Cycle 1, Day 1. A week later, a second dose of glofitamab will be given (Cycle 1, Day 8), and then another dose will be given a week after that (Cycle 2, Day 1). A week after the last glofitamab dose, the first dose of RO7443904 will be given as an intravenous infusion (Cycle 2, Day 8). From the second dose of RO7443904 onwards (Cycle 3, Day 1), glofitamab will be given with RO7443904 on the same day. From then, RO7443904 and glofitamab will be given together once every three weeks.

      Part Ib: The treatment schedule will be the same as outlined in Part Ia, with the only difference being that the third dose of RO7443904 (Cycle 4, Day 1) will be given as an injection under the skin (subcutaneous) instead of as an intravenous infusion.

      Part II: The treatment schedule will be the same as outlined in Part Ia. The first dose of RO7443904 will be given as an intravenous infusion (Cycle 2, Day 8), but all subsequent doses of RO7443904 will be given as an injection under the skin.

      Part III: The treatment schedule will be the same as outlined in Part Ia, however all doses of RO7443904 will be given as an injection under the skin.

      Part IV: The treatment schedule will be the same as outlined in Part Ia, however a specific dose of RO7443904 will be chosen and given either as an injection under the skin or an intravenous infusion, depending on the results from the previous parts of the clinical trial. This is the dose expansion portion of the clinical trial.  

      Are there any risks or benefits in taking part in this clinical trial?

      The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant, although it may not be greater than the risks related to routine medical care or the natural progression of the health condition. Potential participants will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. These will all be described in an informed consent document (a document that provides people with the information they need to make a decision to volunteer for a clinical trial). A potential participant should also discuss these with members of the research team and with their usual healthcare provider. Anyone interested in taking part in a clinical trial should know as much as possible about the trial and feel comfortable asking the research team any questions about the trial.

      Risks associated with the clinical trial drugs

      Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe and even life-threatening, and can vary from person to person.

      RO7443904 and glofitamab

      RO7443904 has not yet been tested in humans. For this reason, the side effects of this drug are not known at this time. Potential participants will be told about the potential side effects, based on laboratory studies or knowledge of similar drugs.

      Potential participants will be told about the known side effects of glofitamab, which has been studied previously in several clinical trials using human participants, and where relevant, also potential side effects based on human and laboratory studies or knowledge of similar drugs.

      RO7443904 will be given by intravenous infusion (involves inserting a needle into the arm) or subcutaneous injection (involves inserting a needle into the fatty area under the skin of the trunk or limbs). Glofitamab will be given by intravenous infusion. Participants will be told about any known side effects of intravenous infusions or subcutaneous injections. 

      Potential benefits associated with the clinical trial

      Participants' health may or may not improve from participation in the clinical trial, but the information that is collected may help other people who have a similar medical condition in the future.

      For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05219513

      Trial Summary

      This is a first-in human, open-label, Phase 1 dose-escalation study in order to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for intravenous (IV) and/or subcutaneous (SC) dosing schemes of this combination treatment, and to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of this combination treatment in participants with relapsed/refractory B-cell non Hodgkin lymphoma (r/r NHL).

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT05219513 , BP43131 Trial Identifier
      RO7443904, Glofitamab, Obinutuzumab, Tocilizumab Treatments
      Lymphoma, Non-Hodgkin Condition
      Official Title

      An Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Body weight >=40 kg
      • Histologically confirmed hematological malignancy that is expected to express CD19 and CD20 and with clinical evidence of treatment need; 2) relapse after or failure to respond to at least two prior treatment regimens; and 3) no other available treatment options that are known to provide clinical benefit
      • Must have at least one measurable target lesion (>=1.5 cm) in its largest dimension by computed tomography (CT) scan
      • Able and willing to provide a fresh tumor biopsy from a safely accessible site, per Investigator's determination
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
      • Life expectancy of >=12 weeks
      • Adequate liver, hematological and renal function
      • Negative serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection
      • Negative test results for hepatitis C virus (HCV) and HIV
      • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1) Women of non-childbearing potential 2) Women of childbearing potential (WOCBP), who, agree to remain abstinent (refrain from heterosexual intercourse) or use of one highly effective contraceptive method during the treatment period and for at least 18 months after obinutuzumab or 5 months after the final dose of RO7443904, 2 months after final dose of glofitamab or 3 months after the final dose of tocilizumab
      • Male participants must remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom plus an additional contraceptive method with a partner who is a WOCBP during the treatment period and for at least 3 months after obinutuzumab, 5 months after the final dose of RO7443904, 2 months after the final dose of glofitamab or 2 months after the final dose of tocilizumab, whichever is longer
      Exclusion Criteria
      • Circulating lymphoma cells, defined by out-of-range (high) absolute lymphocyte count (ALC) or the presence of abnormal cells in the peripheral blood signifying circulating lymphoma cells
      • Participants with acute bacterial, viral, or fungal infection at screening
      • Participants with known active infection or reactivation of a latent infection
      • Pregnant, breastfeeding, or intending to become pregnant during the study
      • Prior treatment with systemic immunotherapeutic agents
      • History of treatment-emergent, immune-related adverse events (AEs) associated with prior immunotherapeutic agents
      • No persistent AEs from prior anti-cancer therapy Grade >=1
      • Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational or approved anti-cancer agent
      • Prior solid organ transplantation
      • Prior allogeneic stem cell transplant (SCT)
      • Autologous SCT within 100 days prior to obinutuzumab infusion
      • Autoimmune disease in active phase or exacerbation/flare within at least 6 months of enrollment
      • History of immune deficiency disease that increases the risk of infection
      • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
      • History of confirmed progressive multifocal leukoencephalopathy
      • Current or past history of central nervous system (CNS) lymphoma or CNS disease
      • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
      • Major surgery or significant traumatic injury <28 days prior to the GpT infusion or anticipation of the need for major surgery during study treatment
      • Participants with another invasive malignancy in the last 2 years
      • Significant cardiovascular disease
      • Administration of a live, attenuated vaccine within 4 weeks before GpT infusion or anticipation that such a live attenuated vaccine will be required during the study
      • Received systemic immunosuppressive medications
      • History of illicit drug or alcohol abuse within 12 months prior to screening, in the Investigator's judgment
      • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug

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