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CAR T-cell Therapy
Pembro + CAR T-Cell Therapy for Large B-Cell Lymphoma
Phase 2
Recruiting
Research Sponsored by Jennifer Crombie, MD
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 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a new drug combination to treat primary mediastinal B-cell lymphoma that has recurred after prior treatment.
Who is the study for?
Adults (≥18 years) with primary mediastinal B-cell lymphoma that's come back or didn't respond to at least two treatments, or relapsed within a year of initial treatment. They must have measurable cancer on scans and agree to use effective contraception. People can't join if they've had certain other cancers, severe allergies to trial drugs, active infections like hepatitis or HIV, recent heart issues, uncontrolled diseases that could affect the study, or are pregnant.
What is being tested?
The trial is testing pembrolizumab combined with CAR T-cell therapy (axicabtagene-ciloleucel or lisocabtagene maraleucel), plus chemotherapy drugs cyclophosphamide and fludarabine. It aims to see if this mix can help people whose B-cell lymphoma has returned after previous treatments.
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever and fatigue; organ inflammation; infusion-related symptoms; blood cell count changes leading to increased infection risk; and potential harm to unborn babies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete Response (CR) Rate at 6 Months
Secondary study objectives
Complete Response (CR) Rate at 6 Months in patients with EBV+ DLBCL and THRLBCL
Duration of Response (DOR)
Median Progression-free survival (PFS)
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PEMBROLIZUMABExperimental Treatment4 Interventions
* Participants will undergo (leukapheresis) for manufacturing of commercial product as per standard of care (SOC) Cycle 1 Day -21or earlier
* Pembrolizumab will be administered per protocol on cycle 1 day -20 and on day +1 following Chimeric Antigen Receptor (CAR) Therapy Infusion infusion, every 3 weeks for up to 2 years, unless there is confirmed progression of disease or unacceptable toxicity.
* Upon the completion of successful manufacturing, patients will undergo lymphodepleting chemotherapy (fludarabine, cyclophosphamide) for chimeric antigen receptor (CAR) therapy infusion as per SOC.
* Participants will receive Chimeric Antigen Receptor (CAR) Therapy Infusion (SOC) on day 0 in the hospital and will remain in the inpatient setting for observation for a minimum of 7 days or until CAR T-cell toxicities resolve to grade 1 or better. The choice of CAR-T product will be left to the discretion of the treating investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leukapheresis
2016
Completed Phase 2
~710
Pembrolizumab
2017
Completed Phase 3
~2810
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Who is running the clinical trial?
Jennifer Crombie, MDLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,004 Previous Clinical Trials
5,185,365 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for an autoimmune disease in the last 2 years.I have a lymphoma lesion that shows up on PET/CT scans.I am fully active or can carry out light work.My blood counts meet the required levels for treatment.I have not taken steroids or immunosuppressants in the last 7 days.I don't have any health issues that could affect the study's results.I do not have active lung inflammation or scarring.I have not received a live vaccine in the last 30 days.My lymphoma has spread to my brain or spinal cord.I finished IV antibiotics for an infection less than a week ago or have an ongoing infection.I had radiotherapy less than 2 weeks ago.I have a history of Hepatitis B or active Hepatitis C.I haven't had cancer treatment or been in a trial for at least 4 weeks.I have had macrophage activation syndrome or HLH in the past.I am 18 years old or older.I am not eligible for standard CAR-T cell therapy.I do not have serious liver conditions like hepatitis or cirrhosis.My cancer progressed after 2 treatments, or didn't respond to first chemo, or came back within a year of chemo, or I had one treatment and can't have a stem cell transplant.My previous treatment with PD-L1 or PD-1 inhibitors lasted less than 6 months or caused severe side effects.I have not had a stroke, brain bleed, or seizures in the last 3 months.I have severe heart issues, including uncontrolled irregular heartbeat or advanced heart failure.My liver and kidney functions are within the required ranges.I had cancer before, but it's been treated and inactive for over 2 years, or it was a minor skin cancer or early-stage prostate cancer.I have had a solid organ or stem cell transplant.I can provide samples of my tumor tissue for the study.My diagnosis of lymphoma was confirmed with a tissue test.I have previously undergone CAR T-cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: PEMBROLIZUMAB
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.
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