CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143 +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/NCT03338972
NCT03338972Phase 1Completed

A Phase I Study of Adoptive Immunotherapy for Advanced B-Cell Maturation Antigen (BCMA)+ Multiple Myeloma With Autologous CD4+ and CD8+ T Cells Engineered to Express a BCMA-Specific Chimeric Antigen Receptor

Fred Hutchinson Cancer Center·interventional·Posted Nov 9, 2017·Updated Sep 8, 2023

In Brief

A Phase 1 clinical trial evaluating Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143, Cyclophosphamide, and 2 other interventions for Recurrent Plasma Cell Myeloma and Refractory Plasma Cell Myeloma. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This phase I trial studies the side effects and best dose of BCMA CAR-T cells in treating patients with BCMA positive multiple myeloma that has come back or does not respond to treatment. T cells are a type of white blood cell and a major component of the immune system. T-cells that have been genetically modified in the laboratory express BCMA and may kill cancer cells with the protein BCMA on their surface. Giving chemotherapy before BCMA CAR-T cells may reduce the amount of disease and to cause a low lymphocyte (white blood cell) count in the blood, which may help the infused BCMA CAR-T cells survive and expand.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2017
Enrollment StartNov 29, 2017
Primary CompletionMay 3, 2021
Study CompletionMar 22, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.6 years ago

Interventions

Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143biological

Given IV

Cyclophosphamidedrug

Given IV

Fludarabinedrug

Given IV

Leukapheresisprocedure

Undergo leukapheresis