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).

Age range3 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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:
✕. 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).

Dose limiting toxicity (DLT) rate and grade of single dose of Kur-502

Timeframe: 4 weeks post T cell infusion

NCT IDNCT05487651

SponsorAthenex, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12

Dan Lang, MD, PhD

Who can participate

Age range3 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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:
✕. 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).