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CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL

NCT02935543 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-06-22

Study results available
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Summary

This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.

Conditions

  • Leukemia, Acute Lymphoblastic

Interventions

BIOLOGICAL

CART 19

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10\^7 CART19 cells, Day 2, 30% fraction: 3x10\^7-1.5x10\^8 CART19 cells, Day 3, 60% fraction: 6x10\^7-3x10\^8 CART19 cells

Sponsors & Collaborators

Principal Investigators

  • Noelle Frey, MD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-12-12
Completion
2018-12-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935543 on ClinicalTrials.gov