Status:
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
Lead Sponsor:
Kiromic BioPharma Inc.
Collaborating Sponsors:
Stiris Research Inc
Conditions:
Carcinoma, Non-Small-Cell Lung Cancer
Bone Metastases From Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
In this clinical trial, or 'study', participants with locally advanced or metastatic, non-small cell cancer (NSCLC) or solid tumors with bone metastases, will receive KB-GDT-01, an allogeneic (cells f...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06069570
Start Date
November 7 2023
End Date
October 1 2026
Last Update
March 5 2025
Active Locations (5)
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1
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
2
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
3
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
4
Texas Oncology - Tyler
Tyler, Texas, United States, 75702