RECRUITING

Safety Study for a Gamma Delta T Cell Product Used with Low Dose Radiotherapy in Patients with Locally Advanced or Metastatic NSCLC or Solid Tumors with Bone Metastases

Conditions

Carcinoma, Non-Small-Cell Lung Cancer Bone Metastases from Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with locally advanced or metastatic non-small cell lung cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.

Official Title

Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination with Low Dose Radiotherapy in Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer or Solid Tumors with Bone Metastases

Quick Facts

Study Start:2023-11-07

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06069570

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Signed and dated informed consent form. * Male or female, \> 18 years old. * Minimum body weight of 50 kilograms (kg). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Histologically or cytologically confirmed locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis * Progressed on SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors (NSCLC), and are not a candidate for further standard anti-neoplastic therapy and/or have exhibited intolerance to and/or declined clinically applicable salvage therapies, and/or have declined therapy. * Genomic screening, with tumors with known actionable molecular alterations, such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriate target-directed molecular therapy. * At least one measurable target lesion based on RECIST v1.1 confirmed by radiological imaging. Participants with isolated bone metastases are eligible for enrollment are not required to have measurable disease * All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia. * Adequate hematopoietic, hepatic and renal function * Agree to adequate contraception for up to 120 days after the last dose of study drug. * Negative serum pregnancy test for women of childbearing potential * All primary and metastatic disease sites are amenable to LDRT * For solid tumors with bone metastases subjects (Part 2 Cohort B): receiving zoledronic acid for solid tumors with bone metastases	* Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day 1. * Major surgery, except for vascular access placement, within the 30 days prior to study Day 1. * Active autoimmune disease requiring immunosuppressive therapy. * Infection requiring systemic treatment within 30 days prior to study Day 1. * History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules. * Uncontrolled hypertension, history of arrhythmia including atrial fibrillation, unstable angina, decompensated congestive heart failure, cardiac ejection fraction ≤ 50%, myocardial infarction, or marked baseline prolonged QT/QTc intervals. * Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection. * Participation in the treatment portion of a clinical trial or completed a clinical trial within the 30 days prior to the first dose of KB-GDT-01. * Presence of any condition that may, in the opinion of the Investigator, render the patient inappropriate from participating in the study. * Breastfeeding or pregnant female, or patient is expecting to conceive or father children during the study. * Allergy or intolerance to any of the study product ingredients or excipients. * Live vaccines administered within 30 days prior to study Day 1. * Individuals lacking capacity to consent for themselves. * Superior vena cava obstruction * Prior radiation therapy to a selected LDRT treatment site \</= 30 days prior to Day 1.

Inclusion Criteria

Exclusion Criteria

* Signed and dated informed consent form.
* Male or female, \> 18 years old.
* Minimum body weight of 50 kilograms (kg).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Histologically or cytologically confirmed locally advanced or metastatic NSCLC or locally advanced or metastatic solid tumor with bone metastasis
* Progressed on SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors (NSCLC), and are not a candidate for further standard anti-neoplastic therapy and/or have exhibited intolerance to and/or declined clinically applicable salvage therapies, and/or have declined therapy.
* Genomic screening, with tumors with known actionable molecular alterations, such as EGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriate target-directed molecular therapy.
* At least one measurable target lesion based on RECIST v1.1 confirmed by radiological imaging. Participants with isolated bone metastases are eligible for enrollment are not required to have measurable disease
* All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia.
* Adequate hematopoietic, hepatic and renal function
* Agree to adequate contraception for up to 120 days after the last dose of study drug.
* Negative serum pregnancy test for women of childbearing potential
* All primary and metastatic disease sites are amenable to LDRT
* For solid tumors with bone metastases subjects (Part 2 Cohort B): receiving zoledronic acid for solid tumors with bone metastases

* Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day 1.
* Major surgery, except for vascular access placement, within the 30 days prior to study Day 1.
* Active autoimmune disease requiring immunosuppressive therapy.
* Infection requiring systemic treatment within 30 days prior to study Day 1.
* History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules.
* Uncontrolled hypertension, history of arrhythmia including atrial fibrillation, unstable angina, decompensated congestive heart failure, cardiac ejection fraction ≤ 50%, myocardial infarction, or marked baseline prolonged QT/QTc intervals.
* Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection.
* Participation in the treatment portion of a clinical trial or completed a clinical trial within the 30 days prior to the first dose of KB-GDT-01.
* Presence of any condition that may, in the opinion of the Investigator, render the patient inappropriate from participating in the study.
* Breastfeeding or pregnant female, or patient is expecting to conceive or father children during the study.
* Allergy or intolerance to any of the study product ingredients or excipients.
* Live vaccines administered within 30 days prior to study Day 1.
* Individuals lacking capacity to consent for themselves.
* Superior vena cava obstruction
* Prior radiation therapy to a selected LDRT treatment site \</= 30 days prior to Day 1.

Contacts and Locations

Study Contact

Matthew Wagener, BS

CONTACT

1-844-539-2873

mwagener@kiromic.com

Leonardo Mirandola, PhD

CONTACT

1-844-539-2873

lmirandola@kiromic.com

Principal Investigator

Jason J Luke, MD, FACP

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

The University of Arizona Cancer Center

Tucson, Arizona, 85719

United States

Beverly Hills Cancer Center

Beverly Hills, California, 90211

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Texas Oncology - Tyler

Tyler, Texas, 75702

United States

Virginia Oncology Associates

Norfolk, Virginia, 23502

United States

Collaborators and Investigators

Sponsor: Kiromic BioPharma Inc.

Jason J Luke, MD, FACP, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-07

Study Completion Date2026-10

Study Record Updates

Study Start Date2023-11-07

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Carcinoma, Non-Small-Cell Lung Cancer
Bone Metastases from Solid Tumors