CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg) +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03019055
NCT03019055Phase 1Completed
CompareCT.gov

Phase 1/1b Study of Redirected Autologous T Cells Engineered to Contain an Anti CD19 and Anti CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed and/or Refractory CD19 or CD20 Positive B Cell Malignancies

Medical College of Wisconsin·interventional·Posted Jan 12, 2017·Updated Jul 27, 2023

In Brief

A Phase 1 clinical trial evaluating CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg), CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg), and 2 other interventions for Lymphoma, Non-Hodgkin and 3 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Non-Hodgkin, Lymphoma, B-Cell, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
CountriesUnited States
CollaboratorsChildren's Hospital and Health System Foundation, Wisconsin

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 12, 2017
Enrollment StartOct 16, 2017
Primary CompletionOct 1, 2019
Study CompletionAug 24, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.5 years ago

Interventions

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

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)

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

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

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

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)

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

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