Specific T-Lymphocytes for Viral Infections

(Gamma Capture Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Paul Szabolcs, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Paul Szabolcs

No Placebo Group

Trial Summary

What is the purpose of this trial?

The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥1/6 Human Leukocyte Antigens (HLA) -matched, viral specific T cells have efficacy against adenovirus, Cytomegalovirus (CMV), and Epstein Barr Virus (EBV) in subjects who have previously received any type of allogeneic Hematopoietic Cell transplant (HCT) or solid organ transplant (SOT) or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. This trial will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus, CMV, or EBV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.

Research Team

Paul Szabolcs, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for people aged 1 month to 65 years who've had a bone marrow or organ transplant, have compromised immunity, and are battling persistent infections from adenovirus, CMV, or EBV despite standard treatments. They must not be pregnant or breastfeeding and should agree to use birth control if applicable.

Inclusion Criteria

I have an Epstein-Barr virus infection or disease.

My adenovirus levels are high despite 2 weeks of antiviral treatment.

I have a persistent Adenovirus, CMV, or EBV infection despite treatment.

Exclusion Criteria

If you have any other medical issues not mentioned here that the doctor thinks might make it risky for you to participate, make it difficult for you to follow study rules, or affect the accuracy of the study results, you may not be able to join.

I am not breastfeeding.

I have moderate to severe graft-versus-host disease.

Treatment Details

Interventions

• Anti-viral T-cell Therapy by Gamma Capture (Virus Therapy)

Trial Overview The study tests the effectiveness of T-cells treated with gamma capture technology against viral infections in patients with weakened immune systems due to transplants or other conditions. It's a phase I/II trial assessing safety and how well these cells fight off specific viruses.

Participant Groups

Group I: Viral Specific T-Lymphocytes Experimental Treatment 1 Intervention

Viral Specific T-Lymphocytes Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.

Who Is Running the Clinical Trial?

Paul Szabolcs

Lead Sponsor

Trials

8

Recruited

230+