Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections

Conditions

• Adenovirus Infection

Eligibility Criteria

Sex

ALL

Age

N/A - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Adenovirus Specific T lymphocytes — BIOLOGICAL
  ADV-VSTs is being proposed for the treatment of refractory ADV infection and/or disease in these populations using haploidentical donors for ease of donor selection, antiviral immunity, coupled with a high-throughput antigen stimulation/IFN-γ capture system (Miltenyi Biotec, CliniMACS Prodigy® System) for rapid and less costly isolation of ADV-VSTs.

Study Details

This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.

Key Dates

First listed

Jan 25, 2021

Start date

Oct 1, 2021

Status verified

May 2025

Primary completion

Oct 1, 2026

Completion

Oct 1, 2027

Study Design

Enrollment

12 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• No Intervention: Donor
  Donors will be evaluated to determine suitability to undergo apheresis collection and their infectious disease status. Donor evaluation will include history and physical examination, laboratory tests, FDA- approved donor testing of communicable diseases (HIV, HVB, HCV, HTLV-I, II, WNV, T. pallidum, T. cruzi, and Zika virus), ABO and Rh typing, pregnancy tests, and donor serology for ADV. Qualified donors will undergo leukapheresis. Collection will proceed for 2 hours or 2 blood volumes, whichever occurs first.
• Experimental: Recipient
  Recipient will undergo a screening period that will include history and physical examination, laboratory tests, performance status, HLA typing and pregnancy test (if needed). Qualified patients will receive ADV-VSTS infusion from haploidentical donors up to a maximum of 5.0 x 104 interferon gamma-negative cells/kg. All patients will be followed for laboratory and clinical response, safety, efficacy and tolerance.

Primary Outcome Measure

Safety by measuring unacceptable toxicities [ Time Frame: 7-28 days ]

Central Contacts

• Melinda Triplet
  6147226039
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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