CMV-Specific CTLs for CMV Infection Post-Transplant

Phase < 1

Recruiting

Led By Sumithira Vasu, MBBS

Research Sponsored by Sumithira Vasu

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 and 12 months post ctl infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the side effects of donor white blood cells killing cancer cells in patients with cytomegalovirus that has come back after a stem cell or solid organ transplant.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as fever, fatigue, infusion-related symptoms, and possibly an increased risk of other infections due to the immunological nature of the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from last ctl infusion till death, assessed at 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from last ctl infusion till death, assessed at 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from last ctl infusion till death, assessed at 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events 4.0

Secondary study objectives

Antiviral activity defined as response to viral load

Overall survival

Risk for chronic GVHD

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment (CMV-specific CTLs)Experimental Treatment1 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 Treatment1 Intervention

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

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