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Monoclonal Antibodies
Loncastuximab Tesirine + Mosunetuzumab for Lymphoma
Phase 2
Recruiting
Led By Swetha Kambhampati
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-last dose
Awards & highlights
Study Summary
This trial studies a new combo to treat relapsed/refractory DLBCL: loncastuximab tesirine + mosunetuzumab.
Who is the study for?
Adults (18+) with relapsed or refractory diffuse large B-cell lymphoma, including certain subtypes, who have had at least one prior therapy can join. Participants must be in good physical condition (ECOG <=2), not pregnant or breastfeeding, and willing to use birth control. They should not have active infections like HIV or hepatitis, autoimmune diseases needing treatment, recent major surgery unrelated to diagnosis, or a history of certain severe reactions to similar drugs.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Loncastuximab Tesirine and Mosunetuzumab for treating patients whose diffuse large B-cell lymphoma has returned after treatment or hasn't responded. The study will assess the safety and effectiveness of this drug duo.See study design
What are the potential side effects?
Potential side effects may include allergic reactions due to components produced in Chinese hamster ovary cells, blood disorders from immune system impacts, liver issues from previous conditions being exacerbated by treatment, and possibly severe skin reactions based on past treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years post-last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) (Phase 2)
Unacceptable toxicity (Safety Lead-in)
Secondary outcome measures
Complete response rate (CR) rate
Duration of response (DOR)
Incidence of adverse events
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (oncastuximab tesirine, mosunetuzumab)Experimental Treatment6 Interventions
Patients receive loncastuximab tesirine IV and mosunetuzumab IV on study. Patients also undergo PET/CT scan, biopsy, and collection of blood samples on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Positron Emission Tomography
2008
Completed Phase 2
~2240
Loncastuximab Tesirine
2022
Completed Phase 2
~50
Computed Tomography
2017
Completed Phase 2
~2720
Mosunetuzumab
2019
Completed Phase 2
~140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,405 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,624 Total Patients Enrolled
Swetha KambhampatiPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who can have children and my pregnancy test is negative.I haven't had radiotherapy in the last 2 weeks.I have had a solid organ transplant.I do not have any active infections, except for nail fungus.My white blood cell count is healthy or can be with treatment.I am not pregnant or breastfeeding.I have or might have a long-term active Epstein-Barr virus infection.My lymphoma has spread to my brain or spinal cord.I have or might have had HLH.I have previously been treated with mosunetuzumab or similar medications.I have not had CAR-T therapy in the last 30 days.I've had severe skin reactions or blisters from past immune therapy.I am able to get out of my bed or chair and move around.I am 18 years old or older.I have a tumor that is larger than 1.5 cm, confirmed by CT or PET/CT scan.My liver enzyme (ALT) levels are within the normal range.My blood clotting time is within the target range for my blood thinner medication.I have had a stem cell transplant from a donor.I have had progressive multifocal leukoencephalopathy in the past.I have not received a live vaccine in the last 30 days.My kidneys are working well enough, as shown by tests.I have not had heart disease symptoms, stroke, or a heart attack in the last 6 months.My blood clotting time is within the normal range.My condition worsened or didn't respond after at least one treatment.I haven't used any monoclonal antibody treatments in the last 2 weeks.I have fluid buildup needing drainage or causing breathing issues.I have a significant history of liver disease.I had a stem cell transplant using my own cells less than 30 days ago.I have been treated with loncastuximab tesirine before.I've had severe side effects from previous immune treatments.My bone marrow is affected, but I don't need a specific white blood cell count to qualify.My bilirubin levels are within the normal range, even with liver issues or Gilbert's disease.I am allergic to certain medications made in CHO cells or similar compounds.I have HIV but it's under control with medication and my CD4 count is over 200.My blood clotting levels are within normal range without anticoagulants.My tumor is positive for CD19 and CD20 after my latest treatment.My blood clotting time is within the target range for my anticoagulant therapy.I am capable of having children and use effective birth control.I haven't taken any cancer drugs within the last 2 weeks or 5 half-lives of the drug.My liver enzyme AST levels are within the required range.I agree to provide a tissue sample from my tumor for the study.I do not have any uncontrolled serious illnesses.I have not had major surgery in the last 4 weeks.I am currently being treated for an autoimmune disease.I have been cancer-free for at least 2 years, except for certain skin, cervical, esophageal cancers, or asymptomatic prostate cancer.I don't have active hepatitis B or C, or if I had, it's now undetectable.I have recovered from side effects of cancer treatment, except for hair loss.I am taking 20 mg or less of prednisone daily, except for inhaled/topical steroids or specific medical exceptions.My diagnosis is a specific type of aggressive lymphoma.I have an autoimmune disease but it's either stable or I'm on a stable treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (oncastuximab tesirine, mosunetuzumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned oncastuximab tesirine and mosunetuzumab as a viable treatment option?
"Our team at Power has assigned the treatment of oncastuximab tesirine and mosunetuzumab a safety rating of 2. This reflects that while there is prior clinical data surrounding its safety, efficacy remains to be established."
Answered by AI
Are any new participants being accepted into this research project?
"According to the records available on clinicaltrials.gov, this specific medical trial is now closed for patient enrolment as of January 3rd 2023. It was initially posted in May 5th 2022 but no longer actively recruiters patients at this time; however, there are 3622 other trials that still require participants."
Answered by AI
What are the main goals of this experiment?
"This trial's primary evaluation metric, to be collected over a 30 day period post-treatment, is Overall Response Rate (ORR). A secondary suite of metrics also exist; this includes Complete Response Rate (CR), Duration Of Response (DOR) and Progression Free Survival (PFS). For each measure the 95% exact binomial confidence interval will be calculated using Kaplan Meier estimation with Greenwood error standardisation."
Answered by AI
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