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Immune System Booster for Non-Hodgkin's Lymphoma
Study Summary
This trial will test if an immune system booster (NKTR-255) can help fight cancer after using a modified T-cell therapy (CD19 CAR-T) to treat relapsed/refractory large B-cell lymphoma.
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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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- My lymphoma tests show CD19 presence or it's likely based on my cancer type.I agree to use birth control if I can become pregnant.My organs, including my bone marrow, kidneys, liver, lungs, and heart, are working well.It's been over 2 weeks since my last cancer treatment.I have had a solid organ transplant.I am very active or have minor symptoms that don't limit my daily activities.I have not had serious heart problems in the last 6 months.I have a significant brain or spinal cord condition.I have an active hepatitis B, hepatitis C, or HIV infection.I have been treated with IL-2 or IL-15 drugs before.I am 18 years old or older.I have received specific chemotherapy to prepare for CAR-T cell therapy.I agree to use effective birth control if my partner can get pregnant.I am willing and able to follow the study's schedule and procedures, including getting a tumor biopsy if possible.It has been over 3 months since my last immune therapy.I am experiencing complications from a stem cell transplant.I have not received any live vaccines in the last 30 days.My cancer did not respond to initial treatment and I can't have a stem cell transplant due to other health issues or age.I have not had CD19 CAR-T cell therapy before, except as allowed in this trial.I have no health issues that would stop me from following the study's requirements.I have not taken high doses of steroids or other immune-weakening drugs recently.I have received standard treatments like axi-cel or liso-cel (for both stages) or tisa-cel (for stage 2 only) as per FDA approval.I haven't had autoimmune or inflammatory disorders in the last year.I have an infection that isn't controlled or needs IV drugs to manage.I have had brain cancer or cancer cells in my brain fluid.My recent PET scan shows active cancer.My condition did not improve after at least two different treatments.
- Group 1: Stage 1 NKTR-255 at 3.0 μg/kg
- Group 2: Stage 1 NKTR-255 at 1.5 µg/kg
- Group 3: Stage 1 NKTR-255 at 3.0/6.0 μg/kg
- Group 4: Placebo
- 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
How many health centers are participating in the trial?
"This research requires the participation of 20 different medical locations, such as Stanford University in Palo Alto, Mayo Clinic Jacksonville in Jacksonville and Winship Cancer Institute of Emory University in Atlanta."
Are there still opportunities for participants in this experiment?
"This research endeavour, which was initially announced on December 1st 2022 and lastly updated on December 16th 2022 is not currently enrolling participants. This notwithstanding, 1826 other trials are searching for volunteers right now."
What is the intent of this experiment?
"The primary endpoint of this clinical trial, which spans up to 3 years from the first administration of study drug, is assessing Complete Response (CR) rate at month 6. Secondary endpoints include CR rate at month 3 by Lugano Classification and Best Overall CR Rate as determined by Blinded Independent Central Review (BICR). The last assessed outcome will be Objective Response Rate (ORR) at Month 3 according to BICR's criteria."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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