Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Catherine Bollard
Study ID
NCT03594981
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Viral Infection

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • CMV/AdV /EBV/BKV specific T cells — BIOLOGICAL
    Each cohort of 2 patients will be treated and observed for 45 days for toxicity, dose escalation, and GvHD. The algorithm of sequentially adaptive EffTox trade-off-based design of Thall et al will be used to determine the dose for each cohort. If 1x107CTL/m2 results in unacceptable toxicity or efficacy, the study will be closed to accrual.

Study Details

This Phase I-II dose-finding trial to determine the optimal dose of intravenous (IV) injection dose of donor-derived cytotoxic T lymphocytes (CTLs) specific for CMV, EBV, BKV and Adenovirus. A maximum of 36 patients will be treated in up to 18 cohorts each of size 2, with the first cohort treated at the lowest dose level 1, all successive doses chosen by the EffTox method, and no untried dose level skipped when escalating. The scientific goal of the trial is to determine an optimal IV-CTL cell dose level among the three doses 1.0x107cells/m2, 2 x107cells/m2 and 5x107cells/m2., hereafter dose levels 1, 2, 3. Dose-finding will be done using the sequentially adaptive EffTox trade-off-based design of Thall et al.

Key Dates

Start date
Jan 24, 2018
Status verified
Aug 2024
Primary completion
Jul 31, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CMV/AdV /EBV/BKV specific T cells
    CMV/AdV /EBV/BKV specific T cells will be thawed and transferred to a syringe given by slow intravenous injection over 1-2 minutes. Three dose levels will be explored. The lowest dose level will be 1x107cells/m2 and the highest will be 5x107/m2.

Primary Outcome Measure

Number of participants with investigational product-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 45 days for toxicity ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's National Health SystemWashington D.C.District of Columbia20010
Fahmida Hoq, MBBS, MS
[email protected]
202-476-3634
Allistair Abraham, MD (PRINCIPAL_INVESTIGATOR)
M.D. Anderson Cancer Center (MDACC)HoustonTexas77030
Amanda Olson, MD
Amanda Olson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
Children's National Health System· Washington D.C., DCM.D. Anderson Cancer Center (MDACC)· Houston, TX

Related Studies