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CAR T-cell Therapy

T Cell Therapy for Cytomegalovirus

Phase < 1

Recruiting

Led By Mari H Dallas, MD

Research Sponsored by Mari Dallas

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3

Patients must have documented opportunistic CMV infection, or reactivation; criteria include asymptomatic viremia (>1000 copies/ml) OR presence of symptoms secondary to CMV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days after transplant

Awards & highlights

Study Summary

This trial will test if a T-cell immunotherapy specific to cytomegalovirus (CMV) is a feasible treatment for CMV infections.

Who is the study for?

This trial is for patients who've had a bone marrow transplant and are over 30 days post-transplant, with CMV infections not improving after antiviral therapy or those experiencing side effects from such treatments. Participants need to be able to consent and use contraception if applicable. Excluded are pregnant/breastfeeding women, recent recipients of certain immune therapies, those with other viral infections or active severe graft vs. host disease.Check my eligibility

What is being tested?

The study tests the feasibility of using donor-derived T-cells that target cytomegalovirus (CMV) in patients who have received a bone marrow transplant. This cell-based immunotherapy aims to bolster the patient's immune response against CMV infection.See study design

What are the potential side effects?

While specific side effects aren't listed here, adoptive T-cell therapy can potentially cause immune reactions, infusion-related symptoms like fever or chills, and may affect how well the transplanted cells engraft.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am capable of limited self-care and spend more than half of my waking hours out of bed.

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I have a CMV infection shown by tests or symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days after transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days after transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days after transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Eradication rate of opportunistic CMV infections

response rate

Trial Design

1Treatment groups

Experimental Treatment

Group I: CMV specific adoptive t-cellsExperimental Treatment1 Intervention

This study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mari DallasLead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

Mari H Dallas, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

CMV specific adoptive t-cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02982902 — Phase < 1

Cytomegalovirus Research Study Groups: CMV specific adoptive t-cells

Cytomegalovirus Clinical Trial 2023: CMV specific adoptive t-cells Highlights & Side Effects. Trial Name: NCT02982902 — Phase < 1

CMV specific adoptive t-cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02982902 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity for participants in this research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this specific experiment has been actively recruiting since May 27th 2020 and is looking for 20 participants at one particular medical site."

Answered by AI

Are there any openings remaining for prospective participants in this clinical research?

"As per information provided on clinicaltrials.gov, this medical experiment is currently open to volunteers and has been ongoing since May 27th 2020 with the last update recorded on July 26th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

T Cell Therapy of Opportunistic Cytomegalovirus Infection

Mari Dallas 2020. "T Cell Therapy of Opportunistic Cytomegalovirus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02982902.

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