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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKiromic BioPharma Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • KB-GDT-01

Treatment groups

48 Participants
are divided into 1 treatment group

Sponsors and collaborators

Kiromic BioPharma Inc.

Lead sponsor

Stiris Research Inc

Collaborator