Phase 1 Lymphoma Trial, Recruiting NCT05169515 Sponsor: Hoffmann-La Roche Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT05169515
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People whose ability to carry out daily activities is rated at a functional level of 0, 1, or 2 on a standard cancer performance scale (where 0 means fully active and 2 means capable of self-care but unable to work)
  • People with a confirmed diagnosis of certain blood cancers expected to carry a protein called CD20 on their cancer cells, including specific types of lymphoma (follicular lymphoma grades 1–3a, or diffuse large B-cell lymphoma/transformed follicular lymphoma), who have already tried at least one or two previous treatments depending on which part of the trial they are joining
  • People with diffuse large B-cell lymphoma or transformed follicular lymphoma who have had only one prior treatment and are not considered suitable for a stem cell transplant using their own cells, or who are not able to receive a specialised cell therapy called CAR-T, for reasons defined by the trial
  • People whose lymphoma shows up as active on a PET scan (a type of imaging scan that detects cancer activity)
  • People who have at least one measurable area of lymphoma visible on a CT or PET/CT scan
  • People who can provide a tumour tissue sample (biopsy) and its associated pathology report for diagnosis confirmation
  • People who have adequate blood count levels without needing growth factor support or blood transfusions in the 14 days before starting the trial
  • People with normal blood test results as required by the trial
  • Women of childbearing potential who agree to use contraception or remain abstinent for specified time periods after treatment ends (the required duration depends on which study drugs are received)
  • Men who agree to use a condom, remain abstinent, and not donate sperm for specified time periods after treatment ends (the required duration depends on which study drugs are received)

Who may not be able to join:

  • People who are pregnant, breastfeeding, or planning to become pregnant during the study or within specified periods after the last dose of study treatment
  • People who have received certain immune-modulating drugs (such as lenalidomide, pomalidomide, or similar medicines) within 4 weeks before starting the relevant study drugs
  • People who are unable to swallow tablets, or who have ongoing moderate-to-severe diarrhoea or absorption problems that cannot be managed with medication
  • People with a specific heart rhythm measurement (QTc interval) above 470 milliseconds on a heart trace (ECG)
  • People who have previously received certain treatments, including the study drugs mosunetuzumab or glofitamab, other similar targeted antibody therapies, a donor stem cell transplant, or a solid organ transplant
  • People who have received certain other treatments too recently before joining — including radiotherapy within the past 2 weeks, a stem cell transplant using their own cells within the past 100 days, CAR-T cell therapy within the past 30 days, certain antibody-based cancer treatments within the past 4 weeks, radioimmunotherapy within the past 12 weeks, immune-suppressing medications within the past 2 weeks, or other cancer treatments within the past 4 weeks or within 5 half-lives of the drug (whichever is shorter)
  • People who have received a live vaccine within 4 weeks before starting the trial, or who are expected to need one during the trial or within 5 months after finishing treatment
  • People with a current or past history of lymphoma that has spread to the brain or spinal fluid
  • People with a history of severe allergic or anaphylactic reactions to antibody-based therapies
  • People with a history of certain autoimmune conditions, including but not limited to lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, myositis, or other conditions where the immune system attacks the body
  • People who have had major surgery or a serious injury within 28 days before joining the trial, or who are expected to need major surgery during the trial
  • People who still have significant side effects from previous cancer treatments that have not improved to a mild level
  • People with other serious ongoing health conditions (such as significant heart, lung, or liver disease, recent stroke, active infection, or others) that could interfere with the trial
  • People joining the glofitamab part of the trial whose cancer did not respond to, or came back within 6 months of, a previous treatment containing a medicine called obinutuzumab

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Trials, Hoffmann-La Roche

Phone: 888-662-6728

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
26 October 2022
Est. completion
15 September 2029

Where this trial is recruiting

🇮🇱 Israel 🇮🇹 Italy 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation]; Percentage of participants with adverse events [all cohorts]; Best overall response rate (ORR), defined as the proportion of participants whose best overall response is a partial response (PR) or a complete response (CR) during the study, as determined by the investigator using Lugano 2014 criteria [dose expansion]; Tolerability, as assessed by the incidence of dose interruptions, dose reductions, dose intensity, and treatment discontinuation [dose escalation]

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov