Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies

Description

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).

Conditions

NHL, Relapsed, Adult, B-cell Lymphoma, B-cell Leukemia, DLBCL - Diffuse Large B Cell Lymphoma, ALL, Adult B Cell, ALL, Childhood, CLL/SLL

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Study Overview

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Study Details

Study overview

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).

Allogeneic Natural Killer T-Cells Expressing CD19 Specific Chimeric Antigen Receptor and Interleukin-15 in Relapsed or Refractory B-Cell Malignancies 2

Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies

Condition
NHL, Relapsed, Adult
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Portland

OHSU - Knight Cancer Center, Portland, Oregon, United States, 97239

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Females who are breastfeeding or pregnant at Screening (as documented by a positive urine or serum pregnancy test; may be performed by local laboratory).
  • 2. Females of childbearing potential who:
  • * Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method \[such as condom plus diaphragm with spermicide\], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) through the Day 365 visit or for 30 days after study drug discontinuation.
  • * Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from sexual activity through the Day 365 visit or for 30 days after study drug discontinuation.
  • * Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive through the Day 365 visit or for 30 days after study drug discontinuation.
  • 3. 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.
  • 4. Currently receiving any investigational agents or received any cellular therapies within the previous 6 weeks prior to the KUR-502 infusion.
  • 5. History of Grade 2 to 4 GvHD.
  • 6. History of hypersensitivity reactions to murine protein-containing products.
  • 7. Active infection with human immunodeficiency virus (HIV) or human T cell lymphotropic virus (HTLV).
  • 8. Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • 9. Uncontrolled active bacterial, fungal, or other viral infection.

Ages Eligible for Study

3 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Athenex, Inc.,

Carlos Ramos, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

2024-12