Is NCT06909110 recruiting in Palo Alto, CA?

Yes, NCT06909110 is currently recruiting participants at its Palo Alto, CA location. This viral infections clinical trial is actively enrolling qualified participants.

How do I join the viral infections clinical trial in Palo Alto?

To join this clinical trial in Palo Alto, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Palo Alto clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Viral Infections Clinical Trial in Palo Alto, CA

About This Viral Infections Study in Palo Alto

The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV, and EBV, in subjects who have previously received any type of allogeneic HCT or solid organ transplant (SOT), or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to

Sponsor: Jessie L. Alexander

Who Can Participate

Inclusion Criteria

Patient, parent, or legal guardian must have given written informed consent, according to FDA guidelines. For patients ≥ 7 years of age who are developmentally able, assent or affirmation will be obtained, if feasible.

Male or female, 1 month through 65 years old, inclusive, at the time of informed consent.

Prior allogeneic hematopoietic stem cell transplant, AND/OR prior solid organ transplant (liver, kidney, lung and/or heart, intestinal, pancreatic, and/or multivisceral), AND/OR diagnosis of primary immunodeficiency AND/OR current/recent administration of immunosuppressive therapy for cancer or autoimmune disease.

If receiving steroids, must be able to taper dose to less than 1 mg/kg/day prednisone (or equivalent) prior to cellular infusion.

Negative pregnancy test for females ≥10 years old or who have reached menarche, unless surgically sterilized or post-menopausal.

Diagnosis of Adenovirus, CMV, or EBV infection, persistent despite standard therapy. A. Adenovirus Infection or Disease (at minimum, one of the below sub-criteria must be met):

Active adenovirus infection: (i.e. gastroenteritis, pneumonia, hemorrhagic cystitis, hepatitis, pancreatitis, meningitis) defined as the demonstration of adenovirus by biopsy specimen from affected site(s) (by culture or histology), or the detection of adenovirus by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents)

Refractory adenoviremia: defined as DNAemia ≥1000 copies/mL or \<1 log decrease after at least 2 weeks of appropriate antiviral therapy (i.e. cidofovir, brincidofovir, or other available pharmacological agents)

Intolerance of or contraindication to antiviral medications. B. CMV Infection or Disease (at minimum, one of the below sub-criteria must be met):

Active CMV infection: (i.e. pneumonia, meningitis, retinitis, hepatitis, hemorrhagic cystitis, and/or gastroenteritis) defined as the demonstration of CMV by biopsy specimen from affected site(s) (by culture or histology) or the detection of CMV by culture, PCR or direct fluorescent antibody stain in fluid in the presence of worsening or persistent clinical or imaging findings despite at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents)

Refractory CMV viremia: defined as the continued presence of DNAemia, with ≥1,000 IU/mL or \<1 log decrease after at least 14 days of appropriate antiviral therapy (i.e. Foscarnet, ganciclovir, cidofovir, or other available pharmacological agents)

Intolerance of or contraindication to antiviral medications. C. EBV Infection or Disease (at minimum, one of the below sub-criteria must be met):

EBV DNAemia ≥1000 IU/mL, persistent despite 2 doses of rituximab,

Biopsy proven lymphoma or lymphoproliferative disease with EBV genomes detected in tumor cells by immunocytochemistry (i.e. EBER positive) or in situ PCR,

Clinical or imaging findings consistent with EBV lymphoma or lymphoproliferation with current or recent elevated EBV viral load in peripheral blood in a patient where biopsy is deemed too high risk,

Failure of antiviral therapy, as determined by one of the two bullets below after two weeks of anti-CD20 targeted therapy such as rituximab, i. There was an increase or less than 50% response at sites of lymphoma disease or lymphoproliferation. ii. There was a rise or a fall of less than 50% in EBV viral load in peripheral blood.

Intolerance or contraindication to rituximab. Patient

Exclusion Criteria

Received ATG or Alemtuzumab within 21 days of viral-specific T cell infusion and a lack of evidence of T cell survival, defined by \<10 CD3+ T cells/uL (in unique situations, plasmapheresis may be considered).

Active acute GVHD grades II-IV.

Active severe chronic GVHD.

Received donor lymphocyte infusion, with the exception of a fraction of an umbilical cord blood, within 21 days of planned viral-specific T cell infusion. Subjects receiving a fraction of an umbilical cord blood within 21 days of the viral-specific T cell infusion will not be excluded.

Active and uncontrolled relapse of malignancy (other than EBV+ post-transplant lymphoproliferative disorder or lymphoma).

Anticipated initiation of new lymphotoxic therapy within 4 weeks of viral-specific T cell infusion.

Patients who are pregnant or lactating.

Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, or concomitant medications, which, in the opinion of the investigator, may pose additional risks to participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study. Donor Inclusion Criteria

Able to understand and sign the consent/assent to the procedure

Partial (2/6 or more) HLA match to the recipient

A pediatric donor could be selected as a donor only if a suitable adult donor is not available (as attested by the research team) or is ineligible according to FACT requirements. For pediatric donors:

Related to the recipient

Apheresis does not need a blood prime before the procedure

Adequate peripheral venous access

Explicit evaluation of the donors' willingness to donate cells, as attested by the research team

Must have understanding that they are helping their ill relative, as attested by the research team

Will gain emotional/psychological benefit from their ability to help and want to donate for a relative, as attested by the research team

Donor is pregnant

Donor is HIV positive

Donor is positive for hepatitis B and/or hepatitis C

Deemed to be a high-risk donor based on responses to donor risk questionnaire

Deemed high risk due to preexisting medical condition or abnormal lab results

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Palo Alto?

Yes, this clinical trial (NCT06909110) has an active research site in Palo Alto, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Viral Infections Treatment Options in Palo Alto, CA

If you're searching for viral infections treatment options in Palo Alto, CA, this clinical trial (NCT06909110) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Palo Alto research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced viral infections specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all viral infections clinical trials near you to find additional studies recruiting in your area.

Viral Infections Clinical Trial in Palo Alto, CA

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