Actively Recruiting

Phase 1
Phase 2
All Genders
NCT03594981

Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis

Led by Catherine Bollard · Updated on 2024-08-28

36

Participants Needed

2

Research Sites

405 weeks

Total Duration

On this page

Sponsors

C

Catherine Bollard

Lead Sponsor

M

M.D. Anderson Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating. The scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells/m2, 2 x107cells/m2 and 5x107cells/m2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.

CONDITIONS

Official Title

Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric and adult patients who are candidates for transplant with malignant or nonmalignant diseases
  • Patients must have a cord blood unit matched at 4, 5, or 6 out of 6 HLA antigens, meeting specific cell dose requirements
  • Recipients of at least one unmanipulated cord blood unit at risk for or with CMV, adenoviral, BKV, or EBV infection or reactivation
  • Lansky/Karnofsky performance score of 60 or higher
  • Absolute neutrophil count (ANC) greater than 500/μL
  • No evidence of graft-versus-host disease greater than Grade II at enrollment
  • Life expectancy greater than 30 days
  • Absence of severe renal disease with creatinine less than three times normal for age
  • Absence of severe liver disease with direct bilirubin less than 3 mg/dL and AST less than five times upper limit of normal
  • At least 30 days post-transplant to be eligible for CTL infusion
  • Written informed consent or signed assent from patient, parent, or guardian
Not Eligible

You will not qualify if you...

  • Pregnant or lactating individuals
  • Patients with active central nervous system disease
  • Karnofsky performance status less than 70%
  • Patients with grade 3 or 4 primary myelofibrosis
  • Patients with suitable related donors
  • Patients on FiO2 greater than 60%
  • Unable to reduce steroids to 0.5 mg/kg/day prednisone or equivalent
  • Patients with Grade 3 hyperbilirubinemia
  • Patients with uncontrolled infections other than CMV, adenovirus, EBV, or BK virus
  • Patients with less than 50% donor chimerism in blood or bone marrow or with disease relapse
  • Patients who received investigational products within 28 days prior to CTL infusion screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Children's National Health System

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

2

M.D. Anderson Cancer Center (MDACC)

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Allistair Abraham, MD

CONTACT

F

Fahmida Hoq, MBBS, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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