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New treatment option for Viral Infection
Official title TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
ClinicalTrials.gov ID: NCT04013802
What this study is testing
What is HLA-matched VSTs?
HLA-matched VSTs 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
- The purpose of this study is to use VSTs (virus-specific T cells) from a donor that is a partial HLA (human leukocyte antigen) match with the patient to treat viral infections after an allogeneic hematopoietic stem cell transplant (HSCT). These cells may also have value in CAR-T recipients who have received a product that depletes virus specific T cells.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or...
- Treatment for Infection/Disease will fall into one of 3 categories (options):
- Option 1: Persistent, increasing or recurrent infections despite 7 days of standard therapy;
- a. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as...
- i. CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by...
You likely can't join if
- Patients receiving ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment.
- Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing...
- Patients who are less than 28 days removed from their allogeneic hematopoietic stem cell transplant or who have received donor lymphocyte infusions...
- Patients with active acute GVHD grades II-IV.
- Uncontrolled relapse of malignancy
- Requirement for FiO2 \> 50% oxygen to maintain oxygen saturation \> 90% (peripheral pulse-ox). Note: patients requiring oxygen at FiO2\ 90% are...
See the full eligibility criteria
Who can join
- Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood. Or Received CAR-T cells targeting an antigen...
- Treatment for Infection/Disease will fall into one of 3 categories (options):
- Option 1: Persistent, increasing or recurrent infections despite 7 days of standard therapy;
- a. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet, letermovir or cidofovir. 56...
- i. CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in broncheoalveolar lavage...
- ii. CMV infection: defined as the presence of CMV positivity as detected by PCR or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx or bronchoalveolar lavage.
- b. Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir.
- i. Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or lung or nasopharynx.
- ii. Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, DFA or culture from two or more sites such as stool or blood or urine or lung or nasopharynx.
- c. EBV: For treatment of persistent EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor.58
- i. EBV infection: defined as: (1) Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR;
- ii. (2) Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood.
- d. BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide. No clear standard treatment is defined (section 1.1.5). Cidofovir has been...
- i. BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine or lung.
- ii. BK virus disease is defined as the presence of BK virus detectable by culture or PCR in blood or urine or other body fluids or lungs and symptoms of disease including, but not limited to persistent microscopic or...
- e. JC virus: Treatment of JC virus infection or disease without suitable alternative treatment option. Given the high homology (\>90%) between JC and BK and the fact that BKVSTs targeting VP1 and Large T (as targeted in...
- i. JC virus infection is defined as the presence of elevated JC virus levels as detected by PCR or positive culture in one site such as CSF or blood.
- ii. JC virus disease is defined as defined as the presence of JC virus detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of PML OR detectable JC virus by...
- Option 2: Early treatment for single or multiple infections with EBV, CMV, adenovirus, and/or BK virus will be allowed for patients deemed to be unable to tolerate standard therapy. Patients with multiple CMV, EBV...
- Option 3: For patients having adenovirus and BK virus, the requirement to fail one week of standard therapy would be waived if they meet one of the criteria below:
- They are ≤100 days post- transplant
- They are currently receiving other nephrotoxic agents or marrow-suppressive agents
- They have adenovirus copy number ≥10,000 copies/ml
- Clinical status at enrollment to allow tapering of steroids to equal or less than 0.5 mg/kg/day methylprednisolone (or equivalent).
- Hgb ≥ 7.0 gm/dl
- Available MVSTs must be partially HLA matched with recipient and HLA match must be verified by one of the Principal Investigators.
- Negative pregnancy test in female patients if applicable (childbearing potential who have received a reduced intensity conditioning regimen).
- Written informed consent and/or signed assent line from patient, parent or guardian.
What rules you out
- Patients receiving ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment.
- Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections...
- Patients who are less than 28 days removed from their allogeneic hematopoietic stem cell transplant or who have received donor lymphocyte infusions (DLI) or CAR-T within 28 days.
- Patients with active acute GVHD grades II-IV.
- Uncontrolled relapse of malignancy
- Requirement for FiO2 \> 50% oxygen to maintain oxygen saturation \> 90% (peripheral pulse-ox). Note: patients requiring oxygen at FiO2\ 90% are eligible to receive MVSTs if the reason for this oxygen requirement is...
The study team makes the final eligibility decision.
Where it's taking place
- 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 Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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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.