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Dose Escalation Trial of WT1-Sensitized T Cells for Residual or Relapsed Leukemia After Allogeneic Hematopoietic Progenitor Cell Transplantation

NCT00620633 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-03-02

No results posted yet for this study

Summary

This study will test the safety of giving you specialized white cells from your donor. They are called WT1 sensitized T cells. They have been grown in the lab and are immunized against a protein. The protein is called the Wilms' tumor protein, or WT1. Your leukemic cells make too much of this protein. We want to learn whether the WT1 sensitized T cells will attack the protein and kill the leukemia cells.

Conditions

Interventions

BIOLOGICAL

WT1-sensitized T cells

Eligible patients who consent to enter this trial and for whom WT1 sensitized T cells have been generated in vitro, will receive a single dose of allogeneic WT1-sensitized T cells by bolus intravenous infusion. In this phase I trial, 6 dose levels of T cells will be evaluated, in sequential groups of 3 patients. Dose Escalation will be based on the incidence and severity of toxicities.

Sponsors & Collaborators

Principal Investigators

  • Susan Prockop, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-08
Primary Completion
2021-02-26
Completion
2021-02-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00620633 on ClinicalTrials.gov