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CAR T-cell Therapy

Bispecific Antibodies Post-CAR-T for Lymphoma

Phase 2
Recruiting
Led By Stephen J. Schuster, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of relapsed or refractory large B-cell lymphoma (including transformed follicular lymphoma, and follicular lymphoma Grade 3B) who have relapsed after or failed to respond to at least two prior standard systemic treatment regimens that include at least one prior regimen containing an anthracycline and at least one containing an anti-CD20-directed therapy and for whom there is no available therapy expected to improve survival (e.g., standard chemotherapy, autologous or allogeneic stem cell transplant).
Be at least 30 days after CAR T-cell infusion at time of study enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of first response assessment to up to five years from last dose of bispecific antibody therapy
Awards & highlights

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.

Who is the study for?
This trial is for patients with relapsed or refractory large B-cell lymphoma who have tried at least two treatments, including one with an anthracycline and another targeting CD20. They must be post CAR T-cell therapy by at least 30 days, have a life expectancy of over 12 weeks, measurable disease on scans, and adequate lab results. Participants need to commit to contraception and not be pregnant.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of mosunetuzumab alone (Cohort 1) or combined obinutuzumab and glofitamab (Cohort 2) following CAR T-cell treatment. Patients are assigned to receive either mosunetuzumab first or the combination drugs later in the study.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to monoclonal antibodies, infusion-related reactions like fever or chills, increased risk of infections due to immune system suppression, as well as possible organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My large B-cell lymphoma has not improved after at least two treatments, including an anthracycline and an anti-CD20 therapy.
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It has been over 30 days since my CAR T-cell treatment.
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I've had a recent scan showing a measurable cancer lesion before CAR-T cell therapy.
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My large B-cell lymphoma has not improved after at least two treatments, including an anthracycline and an anti-CD20 therapy.
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I've had a recent scan showing a measurable cancer lesion before CAR-T cell therapy.
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I have a tumor that can be measured and was confirmed by a scan after my CAR T cell treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of first response assessment to up to five years from last dose of bispecific antibody therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of first response assessment to up to five years from last dose of bispecific antibody therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of the percentage of subjects who achieve a complete metabolic response at 26 weeks from date of first infusion as measured by Cheson 14 (ie Lugano) criteria
Assessment of the percentage of subjects who experience hematologic dose limiting toxicity associated with early administration of Mosunetuzumab and glofitimab following SOC CAR-T Cell therapy in patients who stop therapy after 2 cycles.
Assessment of the percentage of subjects who experience non-hematologic dose limiting toxicity associated with early administration of glofitimab following SOC CAR-T Cell therapy.
+1 more
Secondary outcome measures
Determine Response Duration

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment2 Interventions
Participants receive obinutuzumab (1000 mg for each subject) and glofitamab after standard-of-care therapy with CD19-directed CAR T-cells. The dose of glofitamab for each subject will be 30 mg, other than for cycle 1, which will be 12.5 mg glofitamab fractionated over two weeks.
Group II: Cohort 1Experimental Treatment1 Intervention
Participants receive mosunetuzumab 60 mg for cycles 1 and 2 (although fractionated for cycle 1), and 30 mg for all subsequent cycles after standard-of-care therapy with CD19-directed CAR T-cells
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
obinutuzumab
2018
Completed Phase 3
~2630

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,053 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
385 Previous Clinical Trials
144,859 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,699 Total Patients Enrolled

Media Library

CAR-T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04889716 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Cohort 1, Cohort 2
Non-Hodgkin's Lymphoma Clinical Trial 2023: CAR-T Highlights & Side Effects. Trial Name: NCT04889716 — Phase 2
CAR-T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04889716 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~10 spots leftby Dec 2024