Actively 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
Led by Kiromic BioPharma Inc. · Updated on 2025-03-05
48
Participants Needed
5
Research Sites
151 weeks
Total Duration
On this page
Sponsors
K
Kiromic BioPharma Inc.
Lead Sponsor
S
Stiris Research Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Male or female, over 18 years old
- Minimum body weight of 50 kilograms
- ECOG performance status of 0 or 1
- Confirmed locally advanced or metastatic NSCLC or solid tumor with bone metastases
- Progressed on standard therapy including platinum chemotherapy and immune checkpoint inhibitors, or not eligible for further standard therapy
- If tumors have actionable molecular alterations, must have progressed on targeted therapy
- At least one measurable target lesion or isolated bone metastases
- All side effects from previous treatments recovered to mild or less except alopecia
- Adequate blood, liver, and kidney function
- Agree to use adequate contraception for 120 days after last dose
- Negative pregnancy test for women of childbearing potential
- All disease sites suitable for low dose radiotherapy
- For solid tumors with bone metastases (Part 2 Cohort B): receiving zoledronic acid
You will not qualify if you...
- Chemotherapy, investigational, or checkpoint inhibitor therapy within 30 days before study start
- Major surgery within 30 days before study start except vascular access placement
- Active autoimmune disease needing immunosuppressive therapy
- Infection requiring systemic treatment within 30 days before study start
- History of peritoneal, pericardial, or pleural effusions or nodules
- Uncontrolled hypertension, arrhythmia, unstable angina, heart failure, low ejection fraction, recent heart attack, or prolonged QT intervals
- Positive for HIV, Hepatitis B, or Hepatitis C
- Participated in a clinical trial treatment within 30 days before first KB-GDT-01 dose
- Any condition making study participation inappropriate as judged by the investigator
- Breastfeeding or pregnant women, or expecting to conceive or father children during study
- Allergy or intolerance to study product ingredients
- Live vaccines within 30 days before study start
- Unable to consent for themselves
- Superior vena cava obstruction
- Radiation therapy to a planned low dose radiotherapy site within 30 days before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Not Yet Recruiting
2
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
3
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
4
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
Actively Recruiting
5
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
Research Team
M
Matthew Wagener, BS
CONTACT
L
Leonardo Mirandola, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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