Using Multi-virus Cytotoxic T-cells Following T-Cell Depleted Allogeneic HPCT for Prophylaxis Against EBV, ADV, and CMV

NCT01535885 | Completed Phase 1 DMC

• 1 other identifier: CTL-11/157
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol is a phase I study. Patients may be eligible for an infusion of Multi-virus Cytotoxic T Lymphocytes (CTL) if they received a T-cell depleted (TCD) transplant from a related family member or an unrelated donor. Recipients of these types of transplants are severely immune compromised during the early post-transplant period and are more susceptible to certain viruses. The investigators hypothesize that the adoptive transfer of Cytotoxic T Lymphocytes (CTL) against certain viruses: Adenovirus, Cytomegalovirus and Epstein Barr Virus (Ad, CMV, and EBV) will be safe with regard to producing graft versus host disease (GVHD) or other infusion related toxicities.

Conditions

Epstein-Barr Virus Infections; Adenovirus; Cytomegalovirus Infections

Keywords

Cytoxic T Lymphocytes(CTL); T-cell Depleted; Allogeneic Transplant; Epstein Barr Virus; Adenovirus; Cytomegalovirus; Hematopoietic progenitor cell transplantation

Outcome Measures

Primary Outcomes (1)

• To assess toxicity by SAEs scored according to the adaptive CTCAE version 5

  Phase/safety/toxicity

  1 year

Secondary Outcomes (2)

• Evidence of immunity against specific viral pathogens- Ad, CMV and EBV in recipients of Multi-Virus CTLs

  1 year

• The incidence of Ad, EBV, and CMV systemic infections during the first 180 days post-transplant

  1 year

Study Arms (1)

Multi-Virus CTLs

EXPERIMENTAL

The treatment plan delivers a single dose of Multi-Virus CTL to all patients enrolled on study.

Biological: Cytotoxic T Lymphocytes

Interventions

Cytotoxic T Lymphocytes BIOLOGICAL

Patients will be studied in cohorts of 3. Eligible patients will receive a single Multi-Virus CTL line infusion 28-100 days after their transplant. The dose will start at dose level 1 (2.0 x 106/kg). After each cohort of 3 patients has been treated at each of the dose levels, decisions will be made if the next high or lower dose level should be used.

Multi-Virus CTLs

Eligibility Criteria

• Age: Up to 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient age \< 22 years.
• Both genders and all races are eligible.
• The patient population chosen for the T-cell depleted allogeneic HPCT from a related or unrelated allogeneic donor must meet eligibility based on institutional SOPs and/or the IRB approved T cell depleted allogeneic HPCT protocol which they are enrolled.
• Must be willing to sign a written informed consent.
• Patient Organ Status at the time of enrollment (pre-transplant)
• Lansky or Karnofsky score \> 50
• Echocardiogram shortening fraction \> 27%
• Renal function: serum creatinine \< 2 x normal for age
• DLCO \> 50% predicted in patients old enough to comply with PFTs or no baseline oxygen requirement for younger patients.
• Hepatic: AST, ALT \< 5x upper limit of normal; bilirubin \< 2.0 mg/dl
• Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months following CTL infusion. The male partner should use a condom.
• Patients must be between 28 and 100 days post T-cell depleted allogeneic HPCT
• Patients must meet the following criteria (within 72 hours of CTL infusion):
• Achieved primary engraftment with an ANC of at least 1000 per μl for 3 consecutive days.
• No oxygen requirement with oxygen saturations \> 90%.

You may not qualify if:

• Currently enrolled on another Phase I clinical trial.
• Pregnant or nursing
• Overt hematologic manifestations of relapse or persistent disease
• Having \> grade 1 graft-versus-host disease.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Adenoviridae Infections; Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Julie-An Talano, MD

  Medical College of Wisconsin/Children's Hospital of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics and Director of Clinical Pediatric BMT Research

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 20, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

US (1)