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DRUG:

SQZ-PBMC-HPV

i
Other names: SQZ-PBMC-HPV
Associations
Company:
STEMCELL Technologies
Drug class:
Immunostimulant, Cytotoxic T lymphocyte stimulant
Related drugs:
Associations
7ms
Final outcomes analysis of the cell product SQZ-PBMC-HPV Phase 1 trial in incurable HPV16+ solid tumors shows improved overall survival in patients with increased CD8+ T cell tumor infiltration. (PubMed, Mol Carcinog)
In patients with incurable HPV16+ solid tumors treated with SQZ-PBMC-HPV, an increase in CD8+ T cell density within the tumor parenchyma was associated with superior disease control rate and overall survival. The product composition for patients with increased CD8+ T cell density was enriched for T cells.
P1 data • Journal
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CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • GZMB (Granzyme B)
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HLA-A*02
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SQZ-PBMC-HPV
over1year
Phase 1 study to determine the safety and dosing of autologous PBMCs modified to present HPV16 antigens (SQZ-PBMC-HPV) in HLA-A*02+ patients with HPV16+ solid tumors. (PubMed, Invest New Drugs)
SQZ-PBMC-HPV was well tolerated; 5.0 × 10 live cells/kg with double priming was chosen as the recommended Phase 2 dose. Multiple participants exhibited pharmacodynamic changes consistent with immune responses supporting the proposed mechanism of action for SQZ-PBMC-HPV, including patients previously refractory to checkpoint inhibitors.
P1 data • Clinical Trial,Phase I • Journal
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PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A)
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HLA-A*02
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SQZ-PBMC-HPV
over1year
SQZ-PBMC-HPV-101: Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=30, Completed, SQZ Biotechnologies | Active, not recruiting --> Completed | N=200 --> 30 | Trial completion date: Jun 2023 --> Feb 2023
Trial completion • Enrollment change • Trial completion date • Combination therapy • Checkpoint inhibition • Metastases
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HLA-A (Major Histocompatibility Complex, Class I, A)
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HLA-A*02
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Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • SQZ-PBMC-HPV
almost2years
SQZ-PBMC-HPV-101: Study of SQZ-PBMC-HPV in Patients With HPV16+ Recurrent, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1, N=200, Active, not recruiting, SQZ Biotechnologies | Recruiting --> Active, not recruiting | Trial completion date: Nov 2022 --> Mar 2023 | Trial primary completion date: Nov 2022 --> Mar 2023
Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
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HLA-A (Major Histocompatibility Complex, Class I, A)
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HLA-A*02
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Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • SQZ-PBMC-HPV
over3years
[VIRTUAL] Initial results of a first-in-human, dose escalation study of a cell-based vaccine in HLA A*02+ patients (pts) with recurrent, locally advanced or metastatic HPV16+ solid tumors: SQZ-PBMC-HPV-101. (ASCO 2021)
P1 | "These antigen presenting cells (APC) were matured with CpG7909 and were not genetically modified . SQZ-PBMC-HPV-101 demonstrated clinical feasibility of the Cell Squeeze technology and favorable tolerability of engineered APCs . The study allows for the characterization of the immunogenicity of engineered APCs in humans . Preliminary results warrant the testing in combination with CPI ."
P1 data • Clinical
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CD8 (cluster of differentiation 8)
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Promune (agatolimod) • SQZ-PBMC-HPV