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UF-KURE19 CAR-T Cells for Non-Hodgkin Lymphoma
Study Summary
This trial will use the patient's own T cells that have been modified to target cancer by a inactive lentivirus. This is a shorter process than other CAR-T cells and has not been demonstrated to be safe.
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?
Media Library
- I have severe heart failure.I have a significant brain condition like epilepsy, stroke, or Parkinson's.My blood test shows cancerous B cells.I haven't had major heart issues like a heart attack or stroke in the last 6 months.I do not have a second active cancer except for non-dangerous skin cancer or very early stage cancer.It's been less than 28 days since my last experimental treatment.I can take care of myself but might not be able to do heavy physical work.I am not pregnant or breastfeeding and have a negative pregnancy test.I agree to use effective birth control or remain abstinent during and for 6 months after my treatment.My brain or spinal cord lymphoma is in remission, confirmed by tests for at least 90 days.I agree to use effective birth control or remain abstinent during and after the treatment.My tests show early signs of a bone marrow disorder.It has been at least 2 weeks since my last cancer treatment before my leukapheresis.My heart pumps well and I don't have fluid around it.I have hepatitis but my PCR test for it is negative.I have an autoimmune disease and have been on strong immune-suppressing drugs in the last 6 months.My lymphoma is CD19 positive and has not improved after at least 2 treatments.I have HIV/AIDS.I do not have any severe illnesses that would stop me from following the study's requirements.I can breathe well enough, with oxygen levels above 92% without extra oxygen.I have had a stem cell transplant from a donor.I am 18 years old or older.I had a stem cell transplant using my own cells within the last 6 weeks.I can understand and am willing to sign the consent form.My kidneys are functioning well enough, based on a specific calculation.
- Group 1: UF-KURE19 CAR-T cell infusion
- 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
How many participants are currently receiving treatment in this experiment?
"Affirmative. The clinical trial website confirms that this research is actively recruiting participants, and was first posted on October 1st 2023. As of November 21st 2022, the study requires 10 participants to join at two different sites."
Is there still availability for people to join this clinical experiment?
"Per the content on clinicaltrials.gov , this research is actively seeking participants to join the trial which was first promoted on October 1st 2023 and last modified November 21st 2022."
Has the FDA sanctioned UF-KURE19 CAR-T cells for therapeutic usage?
"The safety of UF-KURE19 CAR-T cells was evaluated as a 1 due to the lack of evidence in both its efficacy and alleged security, being that it is only currently at Phase 1."
What is the intended outcome of this medical experiment?
"The primary evaluation objective of this trial, to be measured within 28 days after treatment, is the detection of any toxicities associated with receiving MTD UF-KURE19 CAR-T Cells. Secondary endpoints include evaluating Overall Response (using Lugano Response Criteria for Malignant Lymphoma) and determining Progression-free Survival (PFS), which reflects tumor growth prior to Overal Survival."
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