Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies (NCT05487651) | Clinical Trial Compass
UnknownPhase 1
Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies
United States36 participantsStarted 2022-10-01
Plain-language summary
This study is a multi-center study to evaluate the safety of KUR-502 in subjects with refractory/relapsed B-cell NHL or leukemia (ALL or CLL).
Who can participate
Age range
3 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed written informed consent.
. Diagnosis of CD19+ B-cell lymphoma or leukemia (ALL or CLL).
. The disease is:
. Measurable disease by current criteria (Lugano criteria for lymphomas, IWG criteria for CLL, and detectable disease for ALL).
. Age 3 to 75 years; subjects \<18 years old will not be enrolled as the first subject on any dose level.
. BSA ≤2.4 m2.
. Bilirubin \<2 times the upper limit of normal (ULN) (3 times if the subject has Gilbert syndrome).
. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<5 times ULN.
Exclusion criteria
. Females who are breastfeeding or pregnant at Screening (as documented by a positive urine or serum pregnancy test; may be performed by local laboratory).
. Females of childbearing potential who:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose limiting toxicity (DLT) rate and grade of single dose of Kur-502
. Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception through the Day 365 visit or for 30 days after study drug discontinuation). No sperm donation is allowed through the Day 365 visit or for 30 days after study drug discontinuation.
. Currently receiving any investigational agents or received any cellular therapies within the previous 6 weeks prior to the KUR-502 infusion.
. History of Grade 2 to 4 GvHD.
. History of hypersensitivity reactions to murine protein-containing products.
. Active infection with human immunodeficiency virus (HIV) or human T cell lymphotropic virus (HTLV).
. Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).