Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients

Conditions

• BK Polyomavirus

Eligibility Criteria

Sex

ALL

Age

5 Weeks - 25 Years

Healthy Volunteers

Not accepted

Interventions

• BK-virus specific CTLs — BIOLOGICAL
  HLA Matched Related Donors: BK-virus specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg). HLA Mismatched Related Donors: BK-virus specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg).

Study Details

This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.

Key Dates

Start date

Oct 7, 2019

Status verified

Jun 2026

Primary completion

Jan 30, 2028

Completion

Jan 30, 2029

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: BK cystitis and/or nephropathy
  All patients with symptoms that are consistent with BK cystitis and/or nephropathy (frequency, dysuria, hematuria, elevated creatinine) will have serum quantitative DNA PCR for BK virus level measured in log copies per mL (results also expressed in copies per milliliter), performed in the Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory

Primary Outcome Measure

Number of participants with Grade III-IV acute GVHD [ Time Frame: Up to 8 weeks after last BK-CTL infusion ]

Central Contacts

• Megan Atkinson
  215-590-2820
  [email protected]
• Patricia Hankins, BSN, RN, CCRC
  215-590-5168
  [email protected]

Locations (1)

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