Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC

NCT06064279 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: SPLP-002-23SCSR&D
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Veterans with advanced lung cancer may benefit from recent advances in technologies that is designed to change the activities of their own white blood cells and help kill tumors. However, many cancers can hide from white blood cells making white blood cells less effective in killing tumors. In this study the investigators plan to boost the activity of patients white blood cell by making tumor cells more visible to the white blood cells. This will be done by injecting antibodies and a new drug that together can make white blood cells inside tumors more active. The investigators plan to recruit sixteen people with advanced lung cancer to make sure that this treatment, which has not been done in any humans, is safe and well tolerated.

Conditions

Stage IV NSCLC

Keywords

NSCLC, Immune Checkpoint inhibitor , PDL-1

Outcome Measures

Primary Outcomes (1)

• Assessment of an MTD dose for IT injection of IVIG + poly-ICLC, and IM injection of poly-ICLC given in combination with ICI in patients with stage IV NSCLC. The primary safety endpoint includes short term and long-term dose limiting toxicity (DLT), and o

  Evaluate the safety as assessed by Common Terminology Criteria for Adverse Events version 6 (CTCAE v. 6) of IT injection of IVIG + poly-ICLC, and IM poly-ICLC given in combination with ICI in Veterans with stage IV NSCLC.

  Ten months

Secondary Outcomes (1)

• To assess the percent of patients with increase PD-L1 expression and assess clinical outcome after treatment

  Ten months

Study Arms (1)

Poly-ICLC + IVIG

EXPERIMENTAL

Patients with stage IV NSCLC will be treated with poly-ICLC + IVIG

Drug: Poly ICLC; Drug: IVIG

Interventions

Poly ICLC DRUG

Tol like receptor 3 agonist

Also known as: Hiltonol

Poly-ICLC + IVIG

IVIG DRUG

pooled IVIG

Poly-ICLC + IVIG

Eligibility Criteria

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

You may qualify if:

• Veterans with advanced (stage IV) NSCLC
• Eligible to receive ICI/antiPD-1mAb
• No known mutation actionable for first line treatment
• An Eastern Cooperative Oncology Group (ECOG) performance-status (PS) score of 2 or less (ECOG PS is a 5-point scale in which higher scores reflect greater disability)
• Veterans' responses will be defined as eligible to enroll in HAITEN-ICIs if they meet all criteria
• To minimize the effects of immunosuppression on the ability to induce antitumor immunity, the investigators will recruit those who have not received systemic cytotoxic chemotherapy (e.g., platinum, taxane, pemetrexed, etc.), do not have major immunosuppression, and are not recipients of organ transplantation
• Based on our patient population at the MEDVAMC, the investigators estimate that \~30-40% of participants would be receiving systemic chemotherapy and ICIs concurrently, and \~60-70% will be receiving ICI monotherapy
• Therefore, the investigators anticipate no difficulty in meeting the recruitment goal of 16 persons at our center over two years and \~18 at each of the other sites over the 4-year study period

You may not qualify if:

• Veterans with
• Concurrent other malignancies, except for localized prostate or localized skin cancer
• Uncontrolled rheumatologic diseases (such as rheumatoid arthritis)
• Current usage of biologics or immunosuppressive therapies
• Status post organ transplant
• An acute respiratory illness (pneumonia, bronchitis, upper respiratory tract infection) in the preceding 4 weeks

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oncovir, Inc.: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

poly ICLC; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Farrah Kheradmand, MD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: October 3, 2023
• Study Start: June 4, 2024
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)