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RO7443904 + Glofitamab for Non-Hodgkin's Lymphoma
Study Summary
This trial is testing a new combination treatment for people with relapsed/refractory B-cell non Hodgkin lymphoma. The goal is to find the maximum tolerated dose and evaluate safety and preliminary anti-tumor activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I currently have an active infection or a previously inactive infection that has become active again.I weigh at least 40 kg.I have been diagnosed with progressive multifocal leukoencephalopathy.My blood tests show high lymphocyte counts or abnormal cells, indicating lymphoma.I am a man and will use birth control during and after treatment as required.I have had severe allergic reactions to certain cancer treatments or drugs for treatment side effects.I can provide a new tumor sample from a safe location.I still have side effects from cancer treatment that bother me.I have a condition that weakens my immune system.I do not have any health conditions that would make it unsafe for me to take a new drug.I have not been treated with standard radiotherapy, chemotherapy, or any cancer drugs.I had a stem cell transplant using my own cells less than 100 days ago.I have or had brain lymphoma or disease.I've had side effects from previous immune therapy.My autoimmune disease has not been active or worsened in the last 6 months.You have a history of using illegal drugs or abusing alcohol within the past year, according to the doctor's opinion.I have not had another invasive cancer in the last 2 years.I have previously received immunotherapy.I am fully active or can carry out light work.My blood cancer is resistant to at least two treatments and lacks other beneficial treatment options.I am not pregnant or breastfeeding and agree to use birth control or abstain from sex as required.I haven't had a serious infection within the last 3 days.I have had a solid organ transplant.I do not have any major health issues that could interfere with the study.My doctor expects me to live for at least 12 more weeks.I have had a stem cell transplant from a donor.I have not received a live vaccine within the last 4 weeks and do not plan to during the study.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I haven't taken strong immune system drugs in the last 6 months, except for low-dose steroids.My liver, blood, and kidney functions are all within normal ranges.I have a serious heart condition.
- Group 1: Parts I-III: Dose-escalation of RO7443904
- Group 2: Part IV: Dose-expansion of RO7443904
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA granted approval for Parts I-III: Dose-escalation of RO7443904?
"Our team at Power gave RO7443904 a rating of 1 on the safety scale since this is only Phase 1, meaning there is scant evidence indicating its effectiveness and limited data to suggest that it's safe."
How many subjects are enrolled in this experiment?
"Affirmative. Clinicaltrials.gov information affirms that this clinical trial is currently enrolling patients, which began on February 18th 2022 and was last modified on November 16th 2022. The study requires 200 participants to be recruited from 2 distinct sites."
Are there any available vacancies in this clinical trial?
"As per clinicaltrials.gov, this experiment is presently enrolling individuals. It was first advertised on February 18th 2022 and its most recent update occurred on November 16th 2022."
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