Phase I study of CMV specific CTL generated from third party for treatment of antiviral drug-resistant CMV infection after allogeneic stem cell transplantation

Phase I study of CMV specific CTL generated from third party for treatment of antiviral drug-resistant CMV infection after allogeneic stem cell transplantation - Phase I study of CMV specific CTL generated from third party for treatment of antiviral drug-resistant CMV infection after allogeneic stem cell transplantation

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015556

Enrollment

Registered

2014-10-31

Start date

2014-11-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiviral drug-resistant CMV infection after allogeneic stem cell transplantation

Interventions

Administration of CMV specific CTL induced and expanded from donor peripheral blood of third party

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. After allogeneic hematopoietic stem cell transplantation 2. HLA-A0201/0206 or HLA-A2402 3. Antiviral drug (ganciclovir, valgancyclovir, foscarnet)-resistant CMV infection or CMV infection with difficulty in administering antiviral drugs. 4. Written informed consent from patient or legal representative 5. Fulfill all of the following criteria: Performance status 0-3, GOT /GPT =<10 x upper normal limit (UNL), total bilirubin =<3 x UNL, serum creatinine =<3 x UNL, SpO2>=90% (room air)

Exclusion criteria

Exclusion criteria: 1. Severe or uncontrollable bacterial, fungal,and viral (except CMV) infection 2. Uncontrollable GVHD 3. Uncontrollable heart failure 4. Psychoses 5.History of allergic reaction to albumin

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events and graft-versus-host disease	—

Secondary

Measure	Time frame
Monitoring of CMV reactivation (quantitative PCR and CMV antigenemia) and CMV specific CTL in peripheral blood Clinical course of CMV infection	—

Countries

Japan

Contacts

Public ContactTetsuya Nishida

Nagoya University Hospital Hematology

tnishida@med.nagoya-u.ac.jp052-744-2145

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026