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CAR-20/19-T Cells in Patients With Relapsed/Refractory B Cell ALL

NCT04049383 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Acute Lymphoblastic Leukemia, in Relapse
  • Acute Lymphoblastic Leukemia With Failed Remission
  • Acute Lymphoblastic Leukemia Recurrent
  • Acute Lymphoblastic Leukemia Not Having Achieved Remission
  • Acute Lymphoblastic Leukemia, Pediatric
  • Acute Lymphoblastic Leukemia

Interventions

BIOLOGICAL

CAR-20/19-T cells (5 x 10^5 CAR-20/19-T cells/kg)

The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level -1: 5 x 10\^5 CAR-20/19-T cells/kg

BIOLOGICAL

CAR-20/19-T cells (1 x10^6 CAR-20/19-T cells/kg)

The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level 0: 1 x10\^6 CAR-20/19-T cells/kg (starting dose level)

BIOLOGICAL

CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)

The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. Dose Level 1: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose)

BIOLOGICAL

CAR-20/19-T cells

The investigational agent in this protocol is the CAR-20/19-T cells.CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of three dose levels of CAR-20/19-T cells based on the dose escalation design. The dose expansion dose level is still to be determined and this section will be updated.

Sponsors & Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Julie-An Talano, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-16
Primary Completion
2025-06-01
Completion
2025-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04049383 on ClinicalTrials.gov