Study of Anti-5T4 CAR-NK Cell Therapy in Advanced Solid Tumors

NCT05194709 | Unknown Early Phase 1

• 2 other identifiers: IBR854-T01WX-IBR-8
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an interventional, single arm, open-label, investigator-initiated trial (IIT) to evaluate the safety, tolerability, initial efficacy and pharmacokinetics (PK) of anti-5T4 CAR-NK cells in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events (AEs)

  To evaluate the safety and tolerability of anti-5T4 CAR-NK cells

  From day 1 to day 90 after the last dose

Secondary Outcomes (6)

• Objective response rate (ORR)

  Up to 1 year after infusion

• Progression-free survival (PFS)

  Up to 1 year after infusion

• Overall survival (OS)

  Up to 1 year after infusion

• Disease control rate (DCR)

  Up to 1 year after infusion

• Cytokine release

  Up to 1 year

Study Arms (1)

Anti-5T4 CAR-NK Cells

EXPERIMENTAL

Biological: Anti-CAR-NK Cells

Interventions

Anti-CAR-NK Cells BIOLOGICAL

The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle (21 days). The first administration dose in the first cycle is 3.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10\^9 cells.

Anti-5T4 CAR-NK Cells

Eligibility Criteria

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

You may qualify if:

• Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
• Age: adult at the age of 18-80 (both inclusive), female or male.
• Patients with advanced malignant solid tumors, histologically or cytologically confirmed, who had failed standard therapy, or had no standard therapy, or were not eligible for standard therapy at this stage; tumor biomarkers combined with imaging can be used to diagnose some special advanced tumors.
• Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time \>3 months.
• Organ function during screening should meet the following criteria:
• Absolute neutrophil count (ANC)≥0.8×109/L
• Platelet (PLT)≥50×109/L
• Hemoglobin (Hb)≥80g/L
• Total bilirubin (TBIL)≤2×ULN
• Alanine aminotransferase (ALT)≤3×ULN; Patients with liver metastasis or liver cancer: ≤5×ULN
• Aspartate aminotransferase (AST)≤3×ULN; Patients with liver metastasis or liver cancer: ≤5×ULN
• Creatinine (Cr)≤1.5× ULN
• Creatinine clearance (Ccr) (to be calculated only when Cr \> 1.5× ULN)\>50ml/min/1.73m2 (Cockcroft-Gault formula)
• Activated partial thrombin time (APTT)≤1.5×ULN
• International normalized ratio (INR)≤1.5×ULN

You may not qualify if:

• Have received systemic antitumor therapy, including chemotherapy, immunotherapy, and radical radiotherapy, within 1 week prior to their first use of the study drug.
• Have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug.
• Any prior adoptive cellular immunotherapy.
• Have undergone major organ surgery (excluding needle biopsy or surgery related to this indication) within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period.
• Patients with severe infections that cannot be controlled.
• Patients with a known history of human immunodeficiency virus (HIV) infection, or a history of organ transplantation.
• Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes that was well controlled with hormone replacement therapy, hypothyroidism, skin conditions that did not require systemic therapy (e.g., vitiligo), and other conditions that were well controlled and that the investigator determined were less likely to recur (e.g., childhood asthma in remission).
• Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
• There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, and Ⅱ-Ⅲ degree atrioventricular block, which need clinical intervention;
• The mean QT interval corrected by Fridericia method (QTcF) is prolonged (male\>450ms, female\>470ms);
• Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurring within 6 months before the first administration;
• Patients with heart failure or left ventricular ejection fraction (LVEF) \< 50% in the New York Heart Association (NYHA) classification ≥II;
• Hypertension beyond clinical control.
• Adverse effects of previous antineoplastic therapy have not returned to CTCAE grade 5.0≤2 (except for toxicity that the investigator determined to be of no safety risk, such as alopecia, hypothyroidism stabilized by hormone replacement therapy).
• Central nervous system metastases with clinical symptoms.

Sponsors & Collaborators

• Wuxi People's Hospital: lead
• Imbioray (Hangzhou) Biomedicine Co., Ltd.: collaborator

Study Sites (1)

Wuxi People's Hospital

Wuxi, Jiangsu, China

RECRUITING

Study Officials

• Peihua P Lu, MD

  Wuxi People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peihua Lu, MD

CONTACT

+8613583991399; lyzlyylxm@163.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: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: December 30, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)