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Bispecific Antibodies Post-CAR-T for Lymphoma
Study Summary
This trial is testing an experimental drug to see if it is safe and effective to give to patients who have already received a CAR T-cell infusion. The experimental drug is mosunetuzumab and it will be given to some patients in the study. Other patients will be given a different experimental drug, glofitamab, in combination with obinutuzumab.
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?
Media Library
- I need oxygen or steroids for my lung condition.It has been over 30 days since my CAR T-cell treatment.It has been over 30 days since my CAR T-cell treatment.I've had a recent scan showing a measurable cancer lesion before CAR-T cell therapy.I do not have any current infections or have been hospitalized for one in the last 2 weeks.I haven't taken strong immune system medications, except for low-dose steroids, in the last 2 weeks.My large B-cell lymphoma has not improved after at least two treatments, including an anthracycline and an anti-CD20 therapy.I have been diagnosed with progressive multifocal leukoencephalopathy.I do not have severe heart problems like recent heart attacks or unstable heart rhythms.I have not received a live vaccine within the last 4 weeks and do not plan to during the study.I have a history of autoimmune disease.I do not have any active or long-term infections that could worsen with bispecific antibody therapy.I experienced significant nerve side effects from CAR-T therapy.I have been treated with axicabtagene ciloleucel.I have had a solid organ transplant.I haven't had major surgery in the last 4 weeks.My large B-cell lymphoma has not improved after at least two treatments, including an anthracycline and an anti-CD20 therapy.You are willing to use birth control correctly during the study.You are expected to live for at least 3 months (12 weeks).I've had a recent scan showing a measurable cancer lesion before CAR-T cell therapy.I have a tumor that can be measured and was confirmed by a scan after my CAR T cell treatment.I had severe reactions after CAR-T therapy or still have symptoms from it.I have no other cancers that could interfere with this study.My scans show at least one tumor that can be measured.
- Group 1: Cohort 1
- Group 2: Cohort 2
- 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
To what extent has mosunetuzumab been studied in the past?
"There are a total of 114 clinical trials underway that involve mosunetuzumab. 20 of these ongoing studies are in Phase 3 testing. The majority of research locations for this antibody are situated in La Jolla, California; though, there are 5314 hospitals and clinics running trials worldwide."
What is the FDA's current opinion on mosunetuzumab?
"While there is some evidence that mosunetuzumab is safe, it has not been proven effective yet and thus received a score of 2."
Are investigators actively looking for new test subjects?
"That is correct. The clinicaltrial.gov website indicates that this trial was originally posted on November 5th, 2021 and updated as recently as July 21st, 2022. This study is only enrolling 42 patients at a single location."
How big is the sample size for this research project?
"The most recent update on clinicaltrials.gov was on 7/21/2022, which indicates that the study is actively recruiting participants. The trial was originally posted on 11/5/2021 and is looking for 42 patients at 1 location."
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