Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Advanced Triple Negative Breast Cancer

NCT05686720 | Unknown Early Phase 1

• 1 other identifier: PCZCTP-220702-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ011 in the treatment of advanced triple-negative breast cancer.

Conditions

Advanced Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Events (AEs)

  To evaluate the safety of SZ011 CAR-NK Cells

  Up to 6 months after infusion

• Objective response rate (ORR)

  To evaluate the ORR of SZ011 CAR-NK Cells

  Up to 6 months after infusion

Secondary Outcomes (4)

• Overall survival (OS)

  Up to 6 months after infusion

• Disease control rate (DCR)

  Up to 6 months after infusion

• Progression-free survival (PFS)

  Up to 6 months after infusion

• Duration of remission (DOR)

  Up to 6 months after infusion

Study Arms (1)

SZ011 CAR-NK

EXPERIMENTAL

Drug: SZ011 CAR-NK

Interventions

SZ011 CAR-NK DRUG

In the escalation study, the minimum initial dose was 5.0×10\^6 cells, then increased to 5.0×10\^7 and 2.0×10\^8 cells. The infusion is given every 2 weeks.

SZ011 CAR-NK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily join the study, sign the informed consent form, and have willingness and ability to comply with study procedures.
• Female ≥ 18 years.
• Histologically confirmed advanced TNBC , namely, human epidermal growth receptor 2-negative (HER2-negative) and estrogen receptor-negative (ER-negative) and progesterone receptor-negative (PR-negative).
• The tumor tissue shows positive mesothelin (MESO) detected by immunohistochemistry.
• At least one target lesion that can be stably evaluated at baseline as per the solid tumor efficacy evaluation criteria (RECIST v1.1).
• Progress after receiving second-line or above treatment in the past.
• Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 points.
• Estimated survival time ≥ 12 weeks.
• Important organ function meets the following requirements:
• Blood routine test: neutrophil count (ANC) ≥1.5 × 109/L; Lymphocyte count (LC) ≥0.5×109/L; Platelet count (PLT) ≥75 × 109/L; Hemoglobin (HG) ≥ 90 g/L;
• Blood biochemistry test:
• Liver functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, alkaline phosphatase (ALP)
• ×ULN, total bilirubin (TBIL) ≤1.5×ULN; except in the following cases:For patients with liver metastasis: AST and/or ALT ≤5×ULN, TBIL
• ×ULN; For patients with liver or bone metastasis: ALP≤5×ULN; Renal function: BUN and Cr ≤1.5×ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
• Women of childbearing potential must have a serum pregnancy test performed 7 days before the first dose and be assessed as non-pregnant. Female subjects of childbearing potential must agree to use an efficient method of contraception (e.g., an intrauterine device, contraceptive pill, or condom) within 4 weeks from the date of the informed consent form until the last dose of study drug.

You may not qualify if:

• The patient had other malignancies within the 5 years prior to screening, in addition to cured cervical carcinoma in situ, basal or squamous cell skin cancer, and postoperative ductal carcinoma in situ.
• Patients with active (without medical control or with clinical symptoms) brain metastasis, cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system.
• The patient with moderate to large amount of pleural effusion, intraperitoneal effusion or pericardial effusion that cannot be controlled and need repeated drainage.
• Patients with uncontrolled tumor-related pain judged by the researcher. Subjects in need of analgesic therapy must have a stable analgesic regimen in place by study entry. Symptomatic lesions suitable for palliative radiotherapy should be treated before entering the study.
• The patient has other active virus and bacterial infection with significant clinical significance or systemic fungal infection that cannot be controlled.
• Anyone who has had arterial thromboembolism events (including myocardial infarction, cardiac arrest, cerebrovascular accident, cerebral ischemia, and a history of deep vein thrombosis or pulmonary embolism of Class 3 or above by CTCAE5.0) within six months before enrollment.
• Patients with a history of severe hemorrhagic disease within 6 months before enrollment, or those who were considered by the investigator to have a clear bleeding tendency (such as esophageal varices at risk for bleeding, locally active ulcer lesions, and fecal occult blood \> 2+).
• Anyone who is diagnosed with congenital or acquired immunodeficiency (such as HIV-infected), or active hepatitis (HBV, HCV) infection, or other serious infectious diseases.
• With clinically significant cardiovascular disease: a) uncontrollable hypertension after treatment (systolic blood pressure ≥160mmHg and/ or diastolic blood pressure ≥110 mmHg); b) Has a history of myocardial infarction or unstable angina within 6 months before enrollment; c) Congestive heart failure or grade II heart failure; d) Arrhythmia in serious need of medical treatment, excluding asymptomatic atrial fibrillation with controllable heart rate.
• Patients with a history of allergy to any component of cell products.
• Anyone who has participated in or is participating in other clinical trials within three months.
• Pregnant or lactating women.
• Anyone who was considered by the investigator to be unsuitable to participate in this clinical trial.

Sponsors & Collaborators

• First Affiliated Hospital of Shantou University Medical College: lead
• Guangdong ProCapZoom Biosciences Co., Ltd.: collaborator

Study Sites (1)

Shantou

Shantou, GuangDong, China

Location

Central Study Contacts

Jing Lin, PhD

CONTACT

13531285809; 316603568@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 17, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)