RecruitingPhase 1NCT06069570

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

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.

Checked against the public recordLast updated Mar 5, 2025 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1
U.S. locations5
SponsorKiromic BioPharma Inc.
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Kiromic BioPharma Inc.
Interventions being studied
Biological: KB-GDT-01
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion Criteria: * 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The University of Arizona Cancer CenterTucson, Arizona
  • Beverly Hills Cancer CenterBeverly Hills, California
  • UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
  • Texas Oncology - TylerTyler, Texas
  • Virginia Oncology AssociatesNorfolk, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 5, 2025. Always confirm current availability with the study team.

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