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Virus Therapy

Cytotoxic T-Lymphocytes for Adenovirus Infections

Phase 2

Recruiting

Led By Mitchell Cairo, MD

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

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

Must have

grade 2 renal insufficiency secondary to cidofovir

Age: 0.1 to 30.00 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after last infusion

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of using related donor ADV specific CTLs to treat patients with refractory ADV infection post AlloHSCT, PID or solid organ transplant.

Who is the study for?

This trial is for children, adolescents, and young adults (0.1-30 years old) with stubborn adenovirus infections after a stem cell or organ transplant, or those with primary immunodeficiencies. They must have tried antiviral treatments without success and be in relatively stable condition. A related donor who matches the patient's tissue type and can respond to the virus is also needed.Check my eligibility

What is being tested?

The study tests if special immune cells called cytotoxic T-lymphocytes from a related donor can fight off tough adenovirus infections when standard antiviral drugs fail. These cells are given through an IV and are designed to target the virus directly.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, symptoms similar to flu-like illnesses due to immune response activation, allergic reactions including hypersensitivity, and possibly other unforeseen complications.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function is reduced due to cidofovir treatment.

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I am between 1 month and 30 years old.

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I need a new donor because my original one can't help. The new donor matches me and responds to a specific test.

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I can do most activities by myself.

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I have an Adenovirus infection after a transplant or with a primary immune deficiency.

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My donor has completed all required health screenings.

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I have a related donor with a specific immune response to a virus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after each infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after each infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after each infusion 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 Response to Treatment (Efficacy)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Trial Design

1Treatment groups

Experimental Treatment

Group I: patients with adenoviral infectionExperimental Treatment1 Intervention

patients will receive CTL dose x 1 with 2.5 × 10(4) CD3/kg for matched related donor and 0.5 × 104 CD3/kg for mis-matched related donor. Patients who don't respond to the first infusion may receive up to a total 5 CTL infusions.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER

1,935 Previous Clinical Trials

2,299,853 Total Patients Enrolled

University of California, Los AngelesOTHER

1,530 Previous Clinical Trials

10,278,182 Total Patients Enrolled

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,581,255 Total Patients Enrolled

Media Library

Adenovirus-specific Cytotoxic T-lymphocytes (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03266627 — Phase 2

Adenovirus Research Study Groups: patients with adenoviral infection

Adenovirus Clinical Trial 2023: Adenovirus-specific Cytotoxic T-lymphocytes Highlights & Side Effects. Trial Name: NCT03266627 — Phase 2

Adenovirus-specific Cytotoxic T-lymphocytes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03266627 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned cytotoxic t-lymphocytes for therapeutic use?

"Data surrounding the safety of cytotoxic t-lymphocytes is adequate enough to rank it a 2. This Phase 2 trial has multiple rounds of data demonstrating its security, but no evidence supporting efficacy."

Answered by AI

Is the age eligibility for this medical research restricted to individuals over fifty years of age?

"In adherence to the selection parameters of this trial, patients must be between 1 month and 30 years old."

Answered by AI

Are there any vacant slots available for prospective participants?

"Affirmative. Per the clinicaltrials.gov entry, this clinical trial is currently recruiting human subjects and was initially posted on November 1st 2018. The most recent update took place on September 27th 2022; 20 patients are needed across 9 medical centres."

Answered by AI

Who is eligible to participate in this research endeavor?

"This medical trial seeks 20 individuals afflicted with adenovirus, aged between one month and 30 years old. The performance status must exceed 30%, either by Landsky score or Karnofsky scale (depending on the patient's age). Furthermore, if the original donor is unavailable or unresponsive to T-cell response, a third party allogeneic donor who has at least 1 HLA A, B and DR match to recipient will be accepted as long as they have demonstrated a T-cell reaction towards the relevant viral MACS® GMP PepTivator antigens of adenovirus."

Answered by AI

What is the current tally of medical institutions administering this clinical experiment?

"Presently, the trial is being held in 9 different cities, including Los Angeles, Baltimore and Saint Louis. To limit transport needs should you choose to participate, it's best to visit a clinic near your home."

Answered by AI

To what extent has recruitment for this experiment been successful?

"Affirmative. According to clinicaltrials.gov, the original posting of this trial was on November 1st 2018 and it has recently been updated as of September 27th 2022. It is looking for 20 individuals from 9 different medical centres to participate in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

Mitchell Cairo 2018. "Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03266627.

All > Adenovirus