RecruitingPhase 2NCT04276870

Orphan Indications for CD19 Redirected Autologous T Cells

CD19-Directed Chimeric Antigen Receptor CD19 Redirected Autologous T Cells (CART19) for Orphan Indications of Pediatric B Cell Acute Lymphoblastic Leukemia (B ALL)


Sponsor

Stephan Grupp MD PhD

Enrollment

133 participants

Start Date

Mar 12, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, four-cohort, phase 2 study to determine the efficacy of CART19 in pediatric and young adult patientswith hypodiploid (Cohort A) or t(17;19) B-ALL (Cohort B), infants with very high risk KMT2A B-ALL (Cohort C), and in patients with central nervous system (CNS) relapse who did not receive cranial radiation (XRT) or bone marrow transplantation (BMT) (Cohort D).


Eligibility

Min Age: 0 YearsMax Age: 29 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of immune cell therapy (using reprogrammed T cells that target the CD19 protein) for rare and difficult-to-treat forms of a blood cancer called B-cell acute lymphoblastic leukemia (B-ALL). The trial focuses on specific genetic subtypes of this leukemia. **You may be eligible if...** - You have been diagnosed with CD19-positive B-ALL (a type of leukemia) - Your leukemia has a specific chromosome abnormality — either fewer than 45 chromosomes (hypodiploid) or a specific chromosomal rearrangement (t(17;19)) - You are enrolled in either Cohort A or Cohort B of the study **You may NOT be eligible if...** - You do not have the specific genetic abnormalities required - You are unable to give informed consent - You have other medical conditions that prevent safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMurine CART19

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection with a planned dose of 5x106 CART19 cells/kg on day 0 with possible reinfusion/retreatment


Locations(1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT04276870