MedTrace Logo

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

NCT04186520 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-23

No results posted yet for this study

Summary

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.

Conditions

Interventions

BIOLOGICAL

8/12-Day Production of Cryopreserved Car-T Cells

A fixed cryopreserved dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

BIOLOGICAL

8/12-Day Production of Car-T Cells

A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

BIOLOGICAL

12-Day Production of Car-T Cells

A fixed dose of 2.5 x 10\^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Nirav Shah, MD · Medical College of Wisconsin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-18
Primary Completion
2027-02-28
Completion
2029-02-28
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 NCT04186520 on ClinicalTrials.gov