Cancer, Hematologic Malignancy, Solid Tumor
Conditions
Keywords
Cancer, Solid Tumor, Hematologic Malignancy
Brief summary
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
Detailed description
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
Interventions
DRUGEngineered 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
Sponsors
Westlake Therapeutics
Zhejiang Provincial People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an investigator-initiated, open-label, multicenter, multidose, dose escalation and expansion study to evaluate the safety, tolerability, and efficacy of Erythrocyte-αPD-1 conjugates in patients with advanced malignancies
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures; 2. Regardless of gender, aged 18 to 75 years old (including threshold); 3. Patients with advanced malignant tumors who have been confirmed by histopathology; 4. Patients with histopathologically confirmed unresectable or metastatic solid tumors who have failed systemic treatment or have no effective standard treatment, or who are unwilling to accept standard treatment or are not suitable for standard treatment; 5. ECOG≤1； 6. Expected life ≥ 3 months； 7. Male participants, their spouses, and female participants of childbearing age should agree to use a medically recognized effective contraceptive method from the signing of the informed consent form until 3 months after the last administration; Pregnancy testing results for women of childbearing age within ≤ 7 days before the first trial drug administration must be negative. Women of childbearing age include premenopausal women and women within 2 years after menopause.
Exclusion criteria
1. People with other serious medical diseases, including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious cardiovascular diseases, 2. Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids; 3. Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia; 4. There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment; 5. Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years. 6. Subjects with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination and clinically unstable for at least 14 days prior to enrollment who require steroid treatment; 7. Having hereditary bleeding tendencies or coagulation disorders, or a history of thrombosis, hemolysis, or hemorrhagic diseases; Received significant surgical treatment or obvious traumatic injury within 28 days prior to the start of research treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | through study completion, an average of 1 year | The incidence of adverse events (AE), treatment related adverse events (TRAE), and severe adverse events (SAE) during the treatment of engineered erythrocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics characteristics Peak Plasma Concentration(Cmax) | through study completion, an average of 1 year | The occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after infusion,including Peak Plasma Concentration(Cmax) |
| Pharmacodynamics characteristics Area under the plasma concentration versus time curve（AUC） | through study completion, an average of 1 year | 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). |
| Efficacy of Erythrocyte-αPD-1 Conjugate | per 6 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anti-drug antibody (ADA) | through study completion, an average of 1 year | Describe the number of anti-drug antibodies (ADA) produced by subjects at each time point after treatment. |
| Peripheral immune response assessment | through study completion, an average of 1 year | Immune cell alterations(number of T-cell,etc) in the peripheral are analyzed by flow cytometry. |
Contacts
Primary ContactLiu Yang, PhD
Outcome results
None listed