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Modified T Cell Therapy for Non-Hodgkin's Lymphoma
Study Summary
This trial will study the safety and effectiveness of a modified T cell treatment in adults with relapsed or refractory B-cell non-Hodgkin's lymphoma.
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 have been cancer-free for at least 2 years, except for certain low-risk types.I do not have any untreated serious infections.I have graft-vs-host disease.My PET scan shows active cancer.I do not have active hepatitis B, C, or HIV.I have not had donor lymphocyte infusions in the last 6 weeks.I have not had CAR T-cell therapy before, except for JCAR017 in this study.I have a specific type of B-cell lymphoma and my previous treatments, including anthracycline and rituximab, did not work.I have MCL that has not improved after at least 2 treatments, including specific drugs.I am fully active or can carry out light work.I have suitable veins for a blood filtering procedure.I have had CD19-targeted therapy and my biopsy confirms CD19-positive lymphoma.I stopped my low dose chemotherapy at least 7 days before starting the treatment to reduce my white blood cells.I haven't taken strong chemotherapy drugs within a week before my cell collection procedure.I haven't used experimental drugs within 4 weeks before my leukapheresis, or if I have, my disease progressed and enough time has passed.I've had radiation recently but my cancer is still growing or I have more cancer spots.My heart, lungs, liver, kidneys, and bone marrow are working well.I can provide a biopsy sample from my last cancer relapse or am willing to undergo a new biopsy.I have a significant brain-related condition.I haven't taken certain strong chemotherapy drugs in the last 2 weeks.My cancer has spread to my brain but it's the only place it has spread to.I have a history of heart disease.I have had a stem cell transplant from a donor within the last 3 months.My cancer has spread into blood vessels or caused clots.I am 18 years old or older.I have a blood clot that isn't being managed with stable blood thinners.I haven't taken high doses of steroids before my cell collection or treatment.I haven't had alemtuzumab in the last 6 months or fludarabine/cladribine in the last 3 months.I haven't taken any immune-weakening drugs in the last 4 weeks.
- Group 1: JCAR017 2-dose schedule (no longer accruing)
- Group 2: JCAR017 1-dose schedule
- 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
Are there any opportunities for individuals to join this experimental endeavor?
"Contrary to expectations, clinicaltrials.gov reports that this medical experiment is no longer seeking participants since the last update on November 21st 2022. However, there are 1842 other trials actively recruiting right now."
For what medical condition is lisocabtagene maraleucel (JCAR017) typically prescribed with a two-dose regimen?
"The 2-dose regimen of JCAR017 (lisocabtagene maraleucel) is clinically proven to be effective in treating refractory diffuse large b cell lymphoma (dlbcl), high grade b-cell lymphoma (hgbcl) and patients with prior ≥2 lines of systemic therapy."
Is there a certain level of risk associated with the two-dose regimen of JCAR017 (lisocabtagene maraleucel)?
"Clinical data concerning the safety and efficacy of JCAR017 (lisocabtagene maraleucel) 2-dose schedule is limited, so it was assigned a score of 1."
How many participants are currently involved in the research protocol?
"At this time, the trial is no longer recruiting patients. Its initial posting was on 1/6/2016 and it has been updated most recently on 11/21/2022. If you are searching for other studies, there are currently 1834 trials actively enrolling people with mantle-cell lymphoma and 8 clinical trials enlisting subjects in a JCAR017 (lisocabtagene maraleucel) 2-dose schedule."
What is the ultimate goal of this clinical research?
"For a period of 28 days following the initial (single-dose) or subsequent (2-dose) administration of JCAR017, this medical trial will assess Treatment-related adverse events based on CTCAE v4.03 criteria. Secondary goals include studying Maximum concentration and Time to maximum concentration in peripheral blood as measured by qPCR, plus Duration of response via Lugano standards."
Has anything like this ever been conducted before?
"At present, there are 8 active JCAR017 (lisocabtagene maraleucel) 2-dose schedule trials running internationally in 71 cities and 14 nations. The first of these studies was launched by Juno Therapeutics (a Celgene Subsidiary) back in 2016 with 385 participants; it completed its Phase 1 testing phase successfully but has since concluded without any follow up experiments."
Could you provide details about any other experiments utilizing the two-dose regimen of JCAR017 (lisocabtagene maraleucel)?
"JCAR017 was first trialed in 2016 at Local Institution - 0021, and though 0 studies have been finalized there are 8 presently recruiting participants. The majority of these experiments take place within Chicago, Illinois."
How many medical facilities are currently conducting this research program?
"The current trial is recruiting out of 24 different sites, including cities like Chicago, Seattle and Houston. It is advised that potential participants select the location closest to them in order to reduce time spent travelling if they decide to take part."
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