Using gamma delta T cells with low dose radiotherapy for advanced lung cancer and bone metastases

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

This study is testing whether using special immune cells along with low dose radiation can help people with advanced lung cancer and bone metastases feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kiromic BioPharma Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation, immunotherapy
• Locations: 5 sites (Tucson, Arizona and 4 other locations)
• Trial ID: NCT06069570 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of intravenous infusions of allogeneic gamma delta T cells combined with low dose radiotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) or solid tumors with bone metastases. Participants will undergo a 28-day screening period involving laboratory tests, tumor scans, and biopsies. The trial consists of two parts: a dose escalation phase to determine the optimal dose with minimal adverse effects, followed by a dose expansion phase to further assess safety and effectiveness. The total treatment period lasts 31 days, followed by a short-term follow-up of 30 days and long-term follow-up up to 12 months.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with advanced NSCLC or solid tumors with bone metastases who have progressed on standard therapies and are not candidates for further conventional treatments.

Not a fit: Patients with early-stage cancer or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that enhances the effectiveness of radiotherapy in patients with advanced cancer.

How similar studies have performed: Other studies have shown promise in combining immunotherapy with radiation therapy, suggesting potential for success in this novel approach.

Eligibility criteria

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.

Where this trial is running

Tucson, Arizona and 4 other locations

• The University of Arizona Cancer Center — Tucson, Arizona, United States (Not_yet_recruiting)
• Beverly Hills Cancer Center — Beverly Hills, California, United States (Recruiting)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
• Texas Oncology - Tyler — Tyler, Texas, United States (Recruiting)
• Virginia Oncology Associates — Norfolk, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Jason J Luke, MD, FACP — University of Pittsburgh
• Study coordinator: Matthew Wagener, BS

Conditions Carcinoma, Non-Small-Cell Lung Cancer; Bone Metastases From Solid Tumors