CMV-Specific CTLs for CMV Infection Post-Transplant

Recruiting at 1 trial location

Overseen By Nicole Szuminski

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Sumithira Vasu

Must not be taking: T-cell depleting agents, Steroids

Disqualifiers: Uncontrolled infection, Active GvHD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \[CMV\] specific cytotoxic T-lymphocytes \[CTLs\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \[AdV\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.

Research Team

Sumithira Vasu, MBBS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals who have had a stem cell or solid organ transplant and are experiencing CMV reactivation despite standard treatment. Participants must be at least 30 days post-transplant, with persistent CMV viremia, and not on high doses of steroids or T-cell depleting agents. A suitable donor must be haploidentical and CMV seropositive.

Inclusion Criteria

Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration

Persistent CMV viremia after standard therapy for >= 7 days with or without proven, probable or possible CMV specific organ involvement

Receipt of an allogeneic HCT using bone marrow, peripheral blood, or umbilical cord stem cells

Exclusion Criteria

Receiving > 0.5mg/kg/day of prednisone or steroid equivalent at the time of enrollment

Receipt of anti-thymocyte globulin (ATG), alemtuzumab, or other T-cell depleting agents within 28 days of screening for enrollment

Evidence of uncontrolled infection as follows: Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Patients with hemodynamic instability attributable to bacterial sepsis or new symptoms, worsening physical signs or radiographic findings attributable to concomitant bacterial or fungal infection are excluded. Patients who require ventilator support for CMV pneumonitis are not excluded. Persisting fever without other signs or symptoms will not be interpreted as progressing infection

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive allogeneic cytomegalovirus-specific or adenovirus-specific cytotoxic T lymphocytes intravenously. Participants with persistent infection are eligible for a second infusion after 28 days.

4 weeks

1-2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for adverse events and viral reactivations.

12 months

Periodic visits (in-person)

Treatment Details

Interventions

• Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes

Trial Overview The trial is testing the effectiveness of allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (CTLs) from donors in treating CMV infections that recur after a patient has undergone a transplant. The goal is to see if these white blood cells can target and kill the virus.

Participant Groups

Group I: Treatment (CMV-specific CTLs) Experimental Treatment 1 Intervention

Participants receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.

Group II: Treatment (AdV-specific CTLs) Experimental Treatment 1 Intervention

Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Participants with persistent infection are eligible for second infusion after 28 days.

Who Is Running the Clinical Trial?

Sumithira Vasu

Lead Sponsor

Trials

6

Recruited

140+