Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPVā¦ (NCT04713046) | Clinical Trial Compass
Active ā Not RecruitingPhase 1/2
Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers
United States24 participantsStarted 2023-10-18
Plain-language summary
In this study, haploidentical relatives of a patient with recurrent or metastatic HPV 16-associated malignancy will be vaccinated with a therapeutic human papillomavirus (HPV) vaccine series to generate HPV-specific leukocytes. The cancer patient with recurrent or metastatic HPV16+ cancer will then be randomized to one of two arms: 1) non-myeloablative allogeneic bone marrow transplant or 2) cluster of differentiation 8 (CD8)-depleted donor lymphocyte infusion.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Have pathologically confirmed incurable, locally recurrent or metastatic HPV16+ HNSCC
ā. Male or female ā„ 18 years of age
ā. Have an human leukocyte antigen (HLA) partially mismatched (haploidentical) related donor. Acceptable donors include first degree relatives (parent, child, or haploidentical sibling), half-siblings, or second degree relatives (aunt, uncle, cousin, niece, nephew). A patient who has inherited a recombinant haplotype from the parents is eligible if the donor shares at least 1 HLA antigen at each of the HLA-A, HLA-B, and HLA DR isotype (HLA-DR) loci.
ā. Prior treatment with a platinum-containing regimen
ā. Patients with an FDA-approved indication to receive an anti-programmed cell death protein-1 (PD-1) or anti-programmed death-ligand1 (PD-L1) monoclonal antibody must have received at least one cycle of this therapy prior to receiving treatment on this trial
ā. Life expectancy ā„ 4 months at time of screening
ā. Measurable disease using RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been documented in such lesions
ā. Eastern Cooperative Oncology Group (ECOG) performance status of \< 2 (see Appendix A).
Exclusion criteria
ā. Disease that is suitable for local therapy administered with curative intent
ā. Requires vasopressor or ventilator support
What they're measuring
1
Safety as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Timeframe: 12 months
2
Maximum Tolerated Dose (MTD) of Allogeneic CD4+ T cell Infusion
Timeframe: 12 months
Trial details
NCT IDNCT04713046
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
. Received antithymocyte globulin or similar anti-T-cell antibody therapy ā¤ 4 weeks prior to Cycle 1 Day 1
ā. Diagnosis of immunodeficiency or is receiving systemic steroid therapy \>10 mg/day of prednisone or equivalent, or any other form of immunosuppressive therapy within 7 days prior to Cycle 1 Day 1 of study treatment.
ā. Active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
ā. Active infection requiring systemic therapy
ā. History of (non-infectious) pneumonitis that required steroids or current pneumonitis
ā. Received any live vaccine for up to 30 days prior to enrollment.