RECRUITING

CD22 Redirected Autologous T Cells for ALL

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Conditions

B Cell LeukemiasB Cell LymphomasBiological: CART 22

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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 is a pilot study to determine the feasibility and safety of a single dose of autologous T cells expressing CD22 chimeric antigen receptors expressing tandem TCR-ζ and 4-1BB signaling domains (CART22/CART22-65s cells) in pediatric and young adult subjects with relapsed or refractory B cell acute lymphoblastic leukemia.

Official Title

Pilot Study of Autologous Anti-CD22 Chimeric Antigen Receptor Redirected T Cells in Pediatric Patients With Chemotherapy Resistant Or Refractory Acute Lymphoblastic Leukemia

Quick Facts

Study Start:2016-01-13
Study Completion:2037-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02650414

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:1 Year to 29 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, 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. Active hepatitis B or active hepatitis C.
  2. 2. HIV Infection.
  3. 3. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
  4. 4. Concurrent use of systemic steroids or immunosuppressant medications. Recent or current use of inhaled steroids or physiologic replacement with hydrocortisone is not exclusionary.
  5. 5. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
  6. 6. Pregnant or nursing (lactating) women.
  7. 7. Receipt of a prior investigational study agent within 4 weeks prior to screening visit. \*Note - patients who have received anti-CD19 CART cells (e.g., CART19/CTL019) on an investigational study where cell infusion occurred greater than 4 weeks before the screening visit are NOT excluded.

Contacts and Locations

Study Contact

Mia Benson-Smith
CONTACT
267-426-0762
oncointake@email.chop.edu
Claire White
CONTACT
whiteC3@email.chop.edu

Principal Investigator

Stephan Grupp, MD, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Stephan Grupp, MD, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

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 Date2016-01-13
Study Completion Date2037-12

Study Record Updates

Study Start Date2016-01-13
Study Completion Date2037-12

Terms related to this study

Keywords Provided by Researchers

  • Biological: CART 22

Additional Relevant MeSH Terms

  • B Cell Leukemias
  • B Cell Lymphomas