Actively Recruiting

Early Phase 1
Age: 3Months +
All Genders
NCT02982902

T Cell Therapy of Opportunistic Cytomegalovirus Infection

Led by Mari Dallas · Updated on 2025-10-22

20

Participants Needed

1

Research Sites

426 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).

CONDITIONS

Official Title

T Cell Therapy of Opportunistic Cytomegalovirus Infection

Who Can Participate

Age: 3Months +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have received allogeneic hematopoietic stem cell transplant and be more than 30 days post-transplant at registration
  • Patients must have documented opportunistic CMV infection or reactivation with either asymptomatic viremia (>1000 copies/ml) or CMV-related symptoms
  • Patients must meet one of the following: no improvement in viral load after 14 or more days of antiviral therapy, new or worsening CMV symptoms or organ compromise while on antiviral therapy, contraindications or adverse effects to antiviral therapy, or second recurrence of CMV infection
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
  • Women of childbearing potential and men must agree to use adequate contraception or abstinence 4 weeks before, during, and 3 months after study treatment
  • Ability to understand and willingness to sign informed consent or assent document
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Patients with opportunistic viral infections other than CMV
  • Patients with active grade 2-4 acute graft versus host disease (GVHD), chronic GVHD, or conditions needing high-dose steroids (>0.5 mg/kg/day prednisone or equivalent)
  • Treatment with antithymocyte globulin within 28 days before planned T-cell infusion
  • Treatment with virus-specific T cells within 42 days before planned infusion
  • Donors must be at least 18 years old, partially HLA compatible (matching at least 3 of 6 loci), seropositive for CMV, meet donor selection criteria, and able to undergo leukapheresis or blood donation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44106-5065

Actively Recruiting

Loading map...

Research Team

M

Mari H Dallas, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here