A Phase 1 interventional study of Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes in Cancer, Solid Tumor and Hematologic Malignancy, sponsored by Zhejiang Provincial People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Zhejiang Provincial People's Hospital · Phase 1, Interventional, and Treatment
This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with advanced malignancies
This is an investigator-initiated, multi-center, open-label clinical study to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of Erythrocyte-αPD-1 conjugates in patients with unresectable or metastatic advanced malignancies who have failed previous systemic therapy.
The study was divided into two phases: dose escalation and dose expansion
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 39 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Zhejiang Provincial People's Hospital is the lead sponsor of 60 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dose Escalation of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy
Drug: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes
Dose Expansion of Erythrocyte-αPD-1 conjugate monotherapy in patients with advanced malignancy
Drug: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes
Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes
Incidence of adverse events
The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of engineered erythrocytes
Time frame: through study completion, an average of 1 year
Pharmacodynamics characteristics Peak Plasma Concentration(Cmax)
The occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after infusion,including Peak Plasma Concentration(Cmax)
Time frame: through study completion, an average of 1 year
Pharmacodynamics characteristics Area under the plasma concentration versus time curve（AUC）
The occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after infusion,including Area under the plasma concentration versus time curve (AUC).
Time frame: through study completion, an average of 1 year
Efficacy of Erythrocyte-αPD-1 Conjugate
According to RECIST 1.1, the effectiveness of Erythrocyte-αPD-1 Conjugate injection in the treatment of patients with unresectable or metastatic advanced solid tumors was evaluated. The evaluation indicators included objective response rate (ORR),etc.
Time frame: per 6 weeks
Anti-drug antibody (ADA)
Describe the number of anti-drug antibodies (ADA) produced by subjects at each time point after treatment.
Time frame: through study completion, an average of 1 year
Peripheral immune response assessment
Immune cell alterations(number of T-cell,etc) in the peripheral are analyzed by flow cytometry.
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Zhejiang Provincial People's Hospital