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CAR T-cell Therapy
UF-KURE19 CAR-T Cells for Non-Hodgkin Lymphoma
Phase 1
Recruiting
Led By Changchun Deng, MD, PhD
Research Sponsored by Changchun Deng, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance status ≤ 2
Cardiac ejection fraction of ≥45%, and no evidence of pericardial effusion, as determined by an echocardiogram.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after culture of uf-kure19 car-t cells
Awards & highlights
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.
Who is the study for?
Adults with CD19 positive, non-Hodgkin lymphoma that's come back after at least two treatments or hasn't responded to chemo. They must be in relatively good health, not pregnant, willing to use effective birth control, and have no major organ dysfunction or other serious medical conditions.Check my eligibility
What is being tested?
The trial is testing UF-KURE19 CAR-T cells made from the patient's own T cells modified by a deactivated virus to fight cancer. It also uses Cyclophosphamide and Fludarabine before reinfusing these engineered cells. The process is quicker than other CAR-T therapies.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever and fatigue, possible damage to organs where T-cells attack healthy tissue (like inflammation), and typical chemotherapy-related issues like nausea or low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My heart pumps well and I don't have fluid around it.
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My lymphoma is CD19 positive and has not improved after at least 2 treatments.
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My kidneys are functioning well enough, based on a specific calculation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks after culture of uf-kure19 car-t cells
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks after culture of uf-kure19 car-t cells
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommend dose(s) of UF-KURE19 CAR-T Cells
Toxicities associated with the target dose of UF-KURE19 CAR-T Cells
Secondary outcome measures
Incidence of treatment- emergent AEs (TEAEs)
Overall Response
Rate of UF-KURE19 CAR-T cells manufacture success
Trial Design
1Treatment groups
Experimental Treatment
Group I: UF-KURE19 CAR-T cell infusionExperimental Treatment3 Interventions
The safety and manufacturing feasability of UF-KURE19 will be determined with up to 10 patients being enrolled. Lymphodepleting therapy will begin on Days -4 to -2 with each weight category of participants receiving 30mg/m2/IV of Fludarabine and 500mg/m2/IV of Cyclophosphamide regardless of the level of UF-KURE19 CAR-T cell dosing.
Dosing:
Participants greater than or equal to 50 kg:
Level -1: 8.5 x 10^6 UF-KURE19 CAR-T Cell Dose (CAR positive cells)
Level 1 : 17.5 x 10^6 UF-KURE19 CAR-T Cell Dose
Participants less than 50 kg:
Level -1: 5.5 x 10^6 UF-KURE19 CAR-T Cell Dose
Level 1: 11.5 x 10^6 UF-KURE19 CAR-T Cell Dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Changchun Deng, MDLead Sponsor
James Michael MartinLead Sponsor
Changchun Deng, MD, PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: UF-KURE19 CAR-T cell infusion
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 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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