Actively Recruiting
Adoptive Cord Blood Immunotherapy Using Expanded Cord Blood T Cells for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis
Led by Catherine Bollard · Updated on 2024-08-28
36
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
C
Catherine Bollard
Lead Sponsor
M
M.D. Anderson Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial involves patients at risk for viral infections such as CMV, EBV, BKV, and adenovirus, particularly after umbilical cord blood transplantation. It aims to find the best dose of donor-derived cytotoxic T lymphocytes (CTLs) specific to these viruses using a Phase I-II dose-finding design. The trial uses a method called EffTox to decide on dose levels for intravenous CTL infusions and evaluates toxicity and efficacy to identify the optimal dose. Participants receive intravenous CTL infusions at one of three dose levels: 1x10^7, 2x10^7, or 5x10^7 cells per square meter of body surface area. The CTLs are thawed and injected slowly over 1-2 minutes, starting from day 30 after transplant. The trial treats patients in cohorts of two, observing each for 45 days before deciding on dose escalation. Additional doses may be given 28 days after the first infusion in some cases, especially if partial response or other therapies affect CTL function. Throughout the study, participants are monitored closely for adverse effects related to the infusion during a 45-day toxicity follow-up. Researchers assess the presence of infused CTLs over 12 months to evaluate their impact. Patients undergo regular clinical observations to watch for toxicity, graft-versus-host disease, and viral reactivation. Total participation duration varies depending on dosing and follow-up schedules, with safety and efficacy being key outcome measures.
CONDITIONS
Brief Title
Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric and adult patients with malignant or nonmalignant diseases who are candidates for transplant
- Patients must have a cord blood unit matched at 4, 5, or 6 out of 6 HLA antigens
- The cord blood unit must be cryopreserved in fractions with sufficient total nucleated cells as specified
- Recipients of at least one unmanipulated cord blood unit transplanted and at risk for CMV, Adenoviral, BKV, or EBV infection or reactivation
- Lansky/Karnofsky performance scores of 60 or higher
- Absolute neutrophil count greater than 500 per microliter
- No graft-versus-host disease greater than Grade II at enrollment
- Life expectancy greater than 30 days
- No severe renal disease (Creatinine less than 3 times normal for age)
- No severe hepatic disease (Direct bilirubin less than 3 mg/dl and AST less than 5 times upper limit)
- At least 30 days post-transplant at time of CTL infusion
- Written informed consent or assent obtained
You will not qualify if you...
- Pregnant or lactating individuals
- Patients with active central nervous system disease
- Patients with Karnofsky performance status less than 70%
- Patients with Grade 3 or 4 or primary myelofibrosis
- Patients with suitable related donors
- Patients on FiO2 greater than 60%
- Unable to reduce steroids to 0.5 mg/kg/day prednisone or equivalent
- Patients with Grade 3 hyperbilirubinemia
- Patients with uncontrolled infections other than CMV, adenovirus, EBV, or BK virus
- Patients with less than 50% donor chimerism or relapse of original disease
- Patients who received investigational products within 28 days before screening for CTL infusion under this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 doses over approximately 56 days
Participants receive a single intravenous infusion of CMV/AdV/EBV/BKV-specific T cells starting from approximately 30 days post-transplant. Dose levels are escalated in cohorts to determine the optimal dose. Some participants may receive up to two additional doses 28 days after the first infusion depending on their response.
1 infusion visit and up to 2 additional infusion visits 28 days apart
Duration - 45 days after each infusion
Participants are observed for 45 days after each infusion to monitor for toxicity, graft-versus-host disease, and treatment response.
Frequent visits during 45-day toxicity follow-up per infusion
Trial Site Locations
Total: 2 locations
1
Children's National Health System
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
M.D. Anderson Cancer Center (MDACC)
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Allistair Abraham, MD
F
Fahmida Hoq, MBBS, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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