Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03807063

Rivogenlecleucel Donor Lymphocyte Immunotherapy in Treating Patients With Recurrent Blood Cancers After Stem Cell Transplant

Phase I Trial With "Off-The-Shelf" Third-Party BPX-501 Donor Lymphocyte Immunotherapy to Treat Persistence or Relapse of Hematologic Malignancies After Allogeneic Stem Cell Transplantation

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
12 Months
Healthy volunteers
Not accepted

Summary

This phase I trial studies the side effects and best dose of rivogenlecleucel, and how well it works, in treating patients with blood cancer that has come back (recurrent) after stem cell transplant. Donor T-cell therapy (rivogenlecleucel) may help control transplant-related infections after stem cell transplant.

Detailed description

This is a dose-escalation study of rivogenlecleucel. Each subject may receive up to 3 doses of rivogenlecleucel intravenously (IV), at intervals of no less than 28 days. Subjects meeting protocol-specified severity criteria for acute GVHD, chronic GVHD, cytokine release syndrome (CRS), prolonged aplasia, or encephalopathy will be treated with rimiducid infusion(s). After completion of study treatment, patients are followed up every 6 months for 5 years and then annually for 10 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALRivogenlecleucelGiven IV
DRUGRimiducidGiven IV

Timeline

Start date
2020-01-02
Primary completion
2020-12-31
Completion
2021-12-31
First posted
2019-01-16
Last updated
2020-08-14

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03807063. Inclusion in this directory is not an endorsement.