RECRUITING

CD4CAR for CD4+ Leukemia and Lymphoma

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 designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells. Funding Source - FDA OOPD

Official Title

A Phase I, Multicenter Study of CD4- Directed Chimeric Antigen Receptor Engineered T-cells (CD4CAR) in Patients with Relapsed or Refractory CD4+ Hematological Malignancies

Quick Facts

Study Start:2020-07-09
Study Completion:2040-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03829540

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:12 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. 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

Tara Haney, RN
CONTACT
317-278-4184
tnhaney@iu.edu
Huda Salman, MD
CONTACT
(317) 278-9504
hsalman@iu.edu

Principal Investigator

Huda Salman, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States
Stony Brook Cancer Center
Stony Brook, New York, 11794
United States

Collaborators and Investigators

Sponsor: Huda Salman

  • Huda Salman, MD, PRINCIPAL_INVESTIGATOR, Indiana University

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 Date2020-07-09
Study Completion Date2040-12

Study Record Updates

Study Start Date2020-07-09
Study Completion Date2040-12

Terms related to this study

Keywords Provided by Researchers

  • CD4; T-cell; lymphoma; leukemia; chimeric antigen; CAR-T

Additional Relevant MeSH Terms

  • T-cell Lymphoma
  • T-cell Leukemia