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New treatment option for Viral Infection
Official title Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis
ClinicalTrials.gov ID: NCT03594981
What this study is testing
What is CMV/AdV /EBV/BKV specific T cells?
CMV/AdV /EBV/BKV specific T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for viral infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- at the Time of Procurement
- Pediatric and adult patients (there are no lower and upper age limits for patients) with malignant or nonmalignant diseases who are candidates for...
- Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. The unit...
- be cryopreserved in two fractions, with a minimum of 2.5x107 total nucleated cells (TNC) per kg pre-thaw in the fraction which will be used for the...
- be cryopreserved with a cell dose that totals \> 3x10e7 TNC per kg pre thaw. On thaw, 20% of the total volume will be used for CTL manufacture to...
You likely can't join if
- Exclusion Criteria at the Time of Procurement
- Pregnant or lactating
- Patients with active central nervous system disease
- Patients with Karnofsky performance status \<70%
- Patients with grade 3 or 4 or primary myelofibrosis
- Patients with suitable related donors Exclusion Criteria at the Time of CTL Infusion
See the full eligibility criteria
- at the Time of Procurement
- Pediatric and adult patients (there are no lower and upper age limits for patients) with malignant or nonmalignant diseases who are candidates for transplant.
- Patients must have a CB unit (or units) matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. The unit selected for CTL expansion must be either:
- be cryopreserved in two fractions, with a minimum of 2.5x107 total nucleated cells (TNC) per kg pre-thaw in the fraction which will be used for the primary transplant. The remaining fraction will be used to generate the...
- be cryopreserved with a cell dose that totals \> 3x10e7 TNC per kg pre thaw. On thaw, 20% of the total volume will be used for CTL manufacture to give at day 30 or beyond and the remaining 80% will be used for the...
- For recipients of double CBT, if possible both CB units should be cryopreserved in two fractions and T-cells will be made from both units if possible. at the Time of CTL Infusion
- Recipients of at least one unmanipulated cord blood unit as described above (i.e. from a HLA matched or mismatched unrelated donor) transplant at risk for or with CMV/Adenoviral/BKV and/or EBV infection or reactivation.
- Lansky/Karnofsky scores ≥60
- Absolute neutrophil count (ANC) greater than 500/u
- No evidence of GVHD \> Grade II at time of enrollment
- Life expectancy \> 30 days
- Absence of severe renal disease (Creatinine \< 3x normal for age)
- Absence of severe hepatic disease. Direct bilirubin must be \< 3 mg/dl and AST \< 5x upper limit of normal
- Patient must be at least 30 days post transplant to be eligible to receive CTL
- Written informed consent and/or signed assent line from patient, parent or guardian
- Exclusion Criteria at the Time of Procurement
- Pregnant or lactating
- Patients with active central nervous system disease
- Patients with Karnofsky performance status \<70%
- Patients with grade 3 or 4 or primary myelofibrosis
- Patients with suitable related donors Exclusion Criteria at the Time of CTL Infusion
- Pregnant or lactating
- Patient on Fi02 of \>60%
- Unable to wean steroids to ≤0.5 mg/kg/day prednisone or equivalent
- Patients with Grade 3 hyperbilirubinemia
- Patients with other uncontrolled infections (except CMV and/or adenovirus and/or EBVemia and/or BK viruria/viremia). For bacterial infections, patients must be receiving definitive therapy and have no signs of...
- Patients with less than 50% donor chimerism in either peripheral blood or bone marrow or patients with relapse of original disease
- Patients who have received investigational (IND) product within 28 days of screening for CTL infusion under this study
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.