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Clinical Trial Summary

This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.


Clinical Trial Description

This is a phase 1, interventional, open label, treatment study designed to evaluate the safety and feasibility of infusion of CAR-20/19-T in subjects with B cell ALL who have relapsed after prior therapies or refractory disease and are not candidates for curative intent standard therapy. There will be two phases of this study. First, a dose escalation phase will determine the safe CAR-20/19-T cell dose in patients B-cell ALL. Once the desired dose has been identified there will be a six-patient dose expansion phase at the specified dose level. ;


Study Design


Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia Not Having Achieved Remission
  • Acute Lymphoblastic Leukemia Recurrent
  • Acute Lymphoblastic Leukemia With Failed Remission
  • Acute Lymphoblastic Leukemia, in Relapse
  • Acute Lymphoblastic Leukemia, Pediatric
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

NCT number NCT04049383
Study type Interventional
Source Medical College of Wisconsin
Contact Meredith Beversdorf, RN
Phone 414-266-5891
Email mbeversdorf@childrenswi.org
Status Recruiting
Phase Phase 1
Start date October 16, 2020
Completion date June 1, 2026

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