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Not yet recruiting NCT06528249

Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate in Patients With Advanced Malignancies

Phase I Interventional Cancer Solid Tumor Hematologic Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Engineered erythrocytes (or red blood cells) covalently conjugated with commercially available anti-PD-1 antibodies on their membranes.
Who it may be relevant to
Registry conditions: Cancer, Solid Tumor, Hematologic Malignancy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety, Tolerability and Preliminary Efficacy of Erythrocyte-αPD-1 Conjugate Injection in Patients With Advanced Malignancies

Overview

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

  • 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

Primary outcome measures

  • Incidence of adverse events [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (3)
  • Pharmacodynamics characteristics 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） [Time frame: through study completion, an average of 1 year]
  • Efficacy of Erythrocyte-αPD-1 Conjugate [Time frame: per 6 weeks]

Eligibility criteria

Inclusion criteria

  • The subject signs an informed consent form, understands this study, is willing to follow and has the ability to complete all experimental procedures;
  • Regardless of gender, aged 18 to 75 years old (including threshold);
  • Patients with advanced malignant tumors who have been confirmed by histopathology;
  • 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;
  • ECOG≤1；
  • Expected life ≥ 3 months；
  • 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

  • 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,
  • Patients with clinical symptoms and the need for repeated drainage of pleural and ascitic fluids;
  • Previous or recent history of pulmonary fibrosis, severe lung function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;
  • There have been adverse events related to the use of IO drugs that require permanent cessation of IO treatment;
  • Known to have other malignant tumors, currently progressing or completing treatment at least once in the past 3 years.
  • 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;
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06528249 · WTX212-002CN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗