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

NCT03019055 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-07-27

Study results available
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Summary

This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragment (scFv) coupled to cluster of differentiation CD3ζ (CD3ζ) and co-stimulatory domain 4-1BB (4-1BB) signaling domains in patients with relapsed and/or refractory CD19 or CD20 positive B cell malignancies

Conditions

Interventions

BIOLOGICAL

CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg)

CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Phase 1 Dose Level 0: 2.5 x10\^5 CAR-20/19-T cells/kg (starting dose level)

BIOLOGICAL

CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)

CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Phase 1 Dose Level 1: 7.5 x10\^5 CAR-20/19-T cells/kg

BIOLOGICAL

CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)

CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Phase 1 Dose Level 2: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose) Phase 1b Expansion Dose Level: 2.5 x 10\^6 cells/kg (single infusion)

BIOLOGICAL

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

CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Sponsors & Collaborators

  • Children's Hospital and Health System Foundation, Wisconsin

    collaborator OTHER

  • 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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2019-10-01
Completion
2021-08-24
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 NCT03019055 on ClinicalTrials.gov