Your session is about to expire
← Back to Search
CAR T-cell Therapy
Cell Therapy for Non-Hodgkin's Lymphoma
Phase 2
Recruiting
Research Sponsored by Miltenyi Biomedicine GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
Histologically confirmed DLBCL or associated subtype, defined by WHO 2016 classification
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new cell therapy for adults with a certain kind of blood cancer who have relapsed or who haven't responded to other treatments.
Who is the study for?
Adults with Diffuse Large B-Cell Lymphoma (DLBCL) who have tried at least two other treatments without success can join this study. They should not be candidates for a stem cell transplant or must have chosen not to undergo one. Participants need to be over 18, in fairly good health otherwise, and able to follow birth control guidelines during the trial.Check my eligibility
What is being tested?
The clinical trial is testing MB-CART2019.1 cells' effectiveness and safety in treating DLBCL that has resisted previous therapies. It's an open-label phase II study, meaning everyone gets the treatment and knows what it is, focusing on how well these cells work and their impact on patients.See study design
What are the potential side effects?
While specific side effects of MB-CART2019.1 are not listed here, similar CAR-T therapies often cause flu-like symptoms, fatigue, difficulty breathing, heart issues, confusion or trouble speaking (neurotoxicity), low blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
My diagnosis is DLBCL or a related type, confirmed by a lab test.
Select...
I am not suspected to have lymphoma in my brain or spinal cord.
Select...
My kidneys are functioning well, with a creatinine clearance over 60 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Best Overall Response
Complete Response Rate
Correlation of tumor CD19 and CD20 antigen expression with disease progression and relapse
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single, open labelExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Miltenyi Biomedicine GmbHLead Sponsor
33 Previous Clinical Trials
1,513 Total Patients Enrolled
Remi KaletaStudy DirectorMiltenyi Biomedicine GmbH
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition did not improve after 2 chemotherapy treatments including rituximab and anthracycline, and I either can't have or chose not to have a stem cell transplant.I have an autoimmune disease affecting my nervous system.My total bilirubin level is below 1.5 mg/dl, unless I have Gilbert's syndrome.I have no active brain disease signs, symptoms, or findings on my MRI.I have HIV or active hepatitis B, or I've treated hepatitis with undetectable viral load.I am unable to understand and agree to the study's procedures and risks.I had a stroke over a year ago and any effects from it have not changed.I have hepatitis C but my viral load is undetectable.My CLL has transformed into a more aggressive type of lymphoma.I can provide a recent tumor biopsy sample for the study.I do not have any ongoing serious infections.I am mostly active and can care for myself, even if my cancer has made me less active recently.I am older than 18 years.My diagnosis is DLBCL or a related type, confirmed by a lab test.I have had a stroke in the last year.I haven't had seizures or taken seizure medications in the last year.My cancer is a type of lymphoma that affects the brain.I am not suspected to have lymphoma in my brain or spinal cord.My kidneys are functioning well, with a creatinine clearance over 60 mL/min.You have a neurological disorder that may affect your ability to assess any potential side effects on the nervous system.Your doctor believes you have at least 3 months to live, not counting your main illness.
Research Study Groups:
This trial has the following groups:- Group 1: Single, open label
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.
How many people are being allowed to join this experiment?
"The study requires 65 patients that meet the specific inclusion criteria. Miltenyi Biomedicine GmbH, the sponsor of this trial, will be conducting it from several locations - two being UC San Diego Health in La Jolla and UT Southwestern Medical Center in Dallas."
Answered by AI
Is the FDA okay with MB-CART2019.1?
"While Phase 2 trials don't have the same robust data backing efficacy, MB-CART2019.1's safety was rated a 2 because of the preliminary evidence in its favour."
Answered by AI
Are we still able to enroll in this experiment?
"Yes, you are correct. The study is detailed on clinicaltrials.gov and it is actively recruiting participants. 18 sites are enrolling a total of 65 patients in the trial which was first posted on May 25th, 2021."
Answered by AI
At how many different sites can patients enroll in this trial?
"There are a total of 18 sites currently running this study. If you enroll, it would be helpful to choose the location nearest to you from the following locations: La Jolla, Dallas, Omaha and 15 other centres."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger