RECRUITING

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

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Conditions

NHL, Relapsed, AdultB-cell LymphomaB-cell LeukemiaDLBCL - Diffuse Large B Cell LymphomaALL, Adult B CellALL, ChildhoodCLL/SLL

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-10-01
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05487651

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.

Ages Eligible for Study:3 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 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. 2. Females of childbearing potential who:
  3. * 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.
  4. * 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.
  5. * 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.
  6. 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.
  7. 4. Currently receiving any investigational agents or received any cellular therapies within the previous 6 weeks prior to the KUR-502 infusion.
  8. 5. History of Grade 2 to 4 GvHD.
  9. 6. History of hypersensitivity reactions to murine protein-containing products.
  10. 7. Active infection with human immunodeficiency virus (HIV) or human T cell lymphotropic virus (HTLV).
  11. 8. Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  12. 9. Uncontrolled active bacterial, fungal, or other viral infection.

Contacts and Locations

Study Contact

Dan Lang, MD, PhD
CONTACT
716-970-4187
dlang@athenex.com

Principal Investigator

Carlos Ramos, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
OHSU - Knight Cancer Center
Portland, Oregon, 97239
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Athenex, Inc.

  • Carlos Ramos, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2024-12

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

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