Umbilical Cord Blood Transplant for Hematological Malignancies

Phase 1

Completed

• Conditions: NHL; MDS; Multiple Myeloma; Hodgkin's Disease; CML; AML; ALL
• Interventions: Biological: Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells; Other: Observation Arm

• Registration Number: NCT00891592
• Lead Sponsor: University of Pennsylvania

Brief Summary

This protocol will enroll subjects with advanced hematologic malignancies who do not have a suitable related or unrelated donor to undergo a Stem Cell Transplant.

In this study, subjects will undergo a Stem Cell Transplant using Cord Blood. Part of the cord blood will be used for the Stem Cell Transplant and part of the cord blood will be sent to a laboratory in order to grow the T cells (from the cord blood) and increase the activity of the cord blood T cells.

The purpose of this part of the study is to see if it is safe to give study subjects activated T cells made from a small portion of their donor UCB unit immediately after the UCB transplant. Activated T cells have been used safely in stem cell transplantation studies in the past, but they have never been studied UCB transplantation.

Detailed Description

The main study intervention includes CD3/CD28 ex vivo costimulated T cells derived from a thawed umbilical cord blood unit, co-infused following a myeloablative conditioning regimen.

Activated T cells are T cells that have been activated in the laboratory by exposure to 2 compounds or molecules called CD3 and CD28; when T cells are exposed to both of these compounds at the same time, they become activated or "stimulated" and may be more effective in fighting infections, cancer cells, and promoting the recovery of red cells, white cells, and platelets after transplantation. At the Hospital of the University of Pennsylvania, activated T cells are prepared at the Clinical Cell and Vaccine Production Facility, also known as the CVPF.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-04-29
• Study First Submitted QC: 2009-04-30
• Study First Posted: 2009-05-01
• Primary Completion: 2011-11
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

• Subject is pregnant or lactating.
• Subject has an uncontrolled infection.
• Subject has an active or untreated disease involving the central nervous system.
• Subject has an active or uncontrolled medical condition that would preclude participation in the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Escalation Arm	Ex Vivo CD3/CD28 costimulated Umbilical Cord Blood T cells	Subjects with cord blood stored in more than one fraction will be enrolled into Dose Escalation Arm. Subjects will receive Cord Blood Stem Cell Transplant followed by expanded Cord Blood T cells on Day 0.
Observation Arm	Observation Arm	Subjects with cord blood stored in one fraction will be enrolled into the Observation Arm. Subjects will receive Cord Blood Stem Cell Transplant on Day 0.

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity (DLT) is defined as grade 4 acute GVHD within the first 90 days following infusion.	90 Days post Transplant

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States