Advancing Regenerative Medicine

Stanford's Alpha Clinic supports the advancement of regenerative therapies in the following ways

Real World Consortium

We are pursuing real-world outcomes data in the post-CAR pediatric and adult settings.

Collaborate with the Alpha Clinic Network to develop a charter
Offer consultation on regulatory and IRB protocol best practices
Consult on development of tools and databases for sample tracking and real-world outcomes data analysis
Provide guidance on multi-site data sharing template agreements and standards

Expand Toxicity Guidelines and Safety

We are working with the Alpha Clinic network to build a California Cell Therapy Safety Monitoring Committee (CCTSMC)

Safety guidance for IITs conducted through the CIRM CLIN2 award mechanism and designated as “high-risk”. This includes first-in-human testing, first-in-child testing and therapy using genetically manipulated cells.
Develop best practices and guidelines for toxicity grading and management.
Offer consultation and expertise on safety-related issues, including serious adverse events (SAEs), subject deviations, internal and external audit/monitoring reports, dose escalation decisions based on available AEs and dose limiting toxicity (DLT) determinations, and study halt/termination based on protocol-specified safety rules.

Maintain a Minimum Number of Clinical trials

Current Cell and Gene Therapy Clinical Trial List:

Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Orly R. Klein, MD

Intervention(s):

drug: Posoleucel
drug: Placebo

Eligibility

Inclusion Criteria:

* Undergone allogeneic cell transplantation ≥21 days prior to dosing
* Meet one of the below criteria:

1. AdV viremia DNA ≥10,000 copies/mL, OR
2. AdV viremia DNA results of ≥1,000 copies/mL, AND

1. has absolute lymphocyte count \<180/mm3, OR
2. has received T cell depletion OR
3. had a cord blood transplant.

Exclusion Criteria:

* Grade 3 or higher acute GVHD
* Ongoing therapy with high-dose systemic corticosteroids
* Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
* Pregnant or lactating female unwilling to discontinue nursing prior to randomization
* History of severe prior reactions to blood product transfusions

NOTE: Other protocol-defined inclusion/exclusion criterion may apply.

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

ALL

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Maninder Singh
msclinic@stanford.edu
Not Recruiting

Link to All Stanford Clinical Trials

Stanford Affiliates

The Alpha Clinic Network

We are part of a state-wide network funded by the California Institute for Regenerative Medicine

This network includes:

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