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
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 12 months
- Procedures mentioned: Infusions, Biopsies
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "All participants will receive KB-GDT-01 as intravenous infusions in combination with radiotherapy."
- "After being informed about the study and its potential risks, during the 28-day screening period, all consented participants will have laboratory tests, assessments, tumor scans, and a tumor biopsy."
- "Participants will then attend clinic visits during a 30-day short-term follow-up period, with a subsequent long-term follow-up period up to 12 months."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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.
Study sites (5)
AZ
- The University of Arizona Cancer Center · Tucson, AZ 85719Mikayla Kirby · Study contact · (520) 621-9656 · mikaylakirby@arizona.eduMargaret Ramirez · Study contact · (520) 626-3677 · ramirezm1@arizona.eduRicklie Julian, MD · Principal investigatorMore trials in Tucson
CA
- Beverly Hills Cancer Center · Beverly Hills, CA 90211Ali Muhammad · Study contact · (310) 432-8934 · amuhammad@bhcancercenter.comAfshin Gabayan, MD · Principal investigatorMore trials in Beverly Hills
PA
- UPMC Hillman Cancer Center · Pittsburgh, PA 15232IDDC Referrals · Study contact · (878) 261 6063 · IDDCReferrals@upmc.eduJason Luke, MD · Principal investigatorMore trials in Pittsburgh
TX
- Texas Oncology - Tyler · Tyler, TX 75702Jennifer Castner · Study contact · (903) 579-9800 · Jennifer.castner@usoncology.comDonald Richards, MD, PhD · Principal investigatorMore trials in Tyler
VA
- Virginia Oncology Associates · Norfolk, VA 23502Karen McClain · Study contact · (757) 213-5658 · Karen.mcclain@usoncology.comGary Simmons, DO, MSHA · Principal investigatorMore trials in Norfolk