MedTrace Logo

Autologous ROR1R-CAR-T Cells for Chronic Lymphocytic Leukemia (CLL)

NCT02194374 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-06-12

No results posted yet for this study

Summary

Gene transfer is a process in which the DNA (genetic material) of certain cells is changed. In this study, gene transfer will be performed on a type of white blood cell (called T cells) to recognize leukemia cells in the same person the T cells were collected from.

The goal of this clinical research study is to learn if it is safe to give these genetically-changed T cells back to patients with CLL/SLL. Researchers also want to learn if these cells can help to attack CLL/SLL cells.

Conditions

Interventions

PROCEDURE

ROR1R-CAR-T Cell Infusion

Dose Escalation Cohort starting dose level of ROR1R-CAR-T cells/kg: 105 cell/kg infused via central venous catheter or by vein on Day 1. Dose Expansion Cohort starting dose level of ROR1R-CAR-T cells/kg: MTD from Dose Escalation Cohort.

DRUG

Fludarabine

FCR Regimen: 25 mg/m2 by vein on Days -5, -4, and -3. FBR Regimen: 20 mg/m2 by vein Days -5, -4, and -3.

DRUG

Cyclophosphamide

FCR Regimen : 250 mg/m2 by vein on Days -5, -4, and -3.

DRUG

Rituximab

FCR and FBR Regimen: 375-500 mg/m2 by vein on Day -5. BR Regimen: 375-500 mg/m2 by vein on Day -4.

DRUG

Bendamustine

BR Regimen: 70-90 mg/m2 by vein on Days -4 and -3. FBR Regimen: 30-50 mg/m2 by vein on Days -5 to -3.

Sponsors & Collaborators

  • CLL Global Research Foundation Alliance

    collaborator UNKNOWN

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • William G. Wierda, MD, PHD, BS · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-06-30
Completion
2017-06-30

More Related Trials

Entities

Drugs
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 NCT02194374 on ClinicalTrials.gov