RECRUITING

CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies

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 is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.

Official Title

Phase I/II Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

Quick Facts

Study Start:2020-05-18
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04186520

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:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages: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. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
866-680-0505
cccto@mcw.edu

Principal Investigator

Nirav Shah, MD
PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin

Study Locations (Sites)

Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

  • Nirav Shah, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

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 Date2020-05-18
Study Completion Date2025-01

Study Record Updates

Study Start Date2020-05-18
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • CAR-T
  • Chimeric antigen receptor T-cell therapy
  • CAR Therapy
  • B-cell Malignancies

Additional Relevant MeSH Terms

  • Non Hodgkin Lymphoma (NHL)
  • Mantle Cell Lymphoma (MCL)
  • Chronic Lymphocytic Leukemia (CLL)
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Primary Mediastinal Large B-cell Lymphoma (PMBCL)
  • Central Nervous System Lymphoma