Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC
Study Details
Study Description
Brief Summary
This is a clinical trial studying intravenous infusions of allogeneic gamma delta T cells after receiving low dose radiotherapy in participants with metastatic non-small cell lung cancer to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Phase 1 |
Detailed Description
In this clinical trial, or 'study', participants with stage 4, non-small cell cancer (NSCLC), will receive KB-GDT-01, an allogeneic (cells from healthy donors) gamma delta T-cell product. 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.
Cytokine release syndrome symptoms and other potential adverse effects, will be monitored during the dose limiting toxicity period.
The study will be conducted in 2 parts, with the same number of visits in each part.
In Part 1 Dose Escalation, the study will attempt to identify the best dose with the lowest incidence of adverse effects (AE) and try to identify if the KB-GDT-01 is working (effectiveness). In Part 2 Dose Expansion the best dose will be further investigated for AE and effectiveness. There will be up to 36 participants in Part 1 and up to 12 additional participants in Part 2 of the study.
The total treatment cycle of the study drug protocol will be completed in 10 days. 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 Month 24
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KB-GDT-01 cells Dose Level 1: 400 x10^6, 800 x10^6 or 1600 x10^6 KB-GDT-01 cells + radiation (1.0 Gy/fraction) |
Biological: KB-GDT-01
KB-GDT-01 is an allogeneic, gamma delta T-cell suspension product manufactured from the isolation of healthy donor peripheral blood mononuclear cells (PBMC). The KB-GDT-01 cells are cryopreserved in vapor phase liquid nitrogen (LN2) in 50 mL CryoMACS® cryobags for a total of 200 × 106 viable cells/bag. The KB-GDT-01 cryopreserved product is thawed and administered intravenously (IV) until the entire bag is infused by gravity. Low dose radiotherapy (LDRT) will be administered to selected tumor sites (maximum of 5 isocenters) at 1.0 Gy/fraction on Days 1 and 2, followed by the KB-GDT-01 IV infusion on Day 3. LDRT will be repeated on Days 8 and 9, and the 2nd KB-GDT-01 IV infusion on Day 10.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT [From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later]
DLT, defined as the occurrence or start of a clinically significant Grade 3 or greater AE (per CTCAE v5.0) occurring during the DLT assessment period that cannot be attributed to disease progression, intercurrent illness, or concomitant medication.
Secondary Outcome Measures
- Objective Response Rate (ORR) [From first study drug infusion through to Month 24]
Investigator assessed ORR per RECIST v1.1. ORR is defined as the percentage of participants with a best overall response of complete or partial response.
- Progression Free Survival (PFS) [From first study drug infusion until the first evidence of disease progression, death or Month 24.]
Investigator assessed PFS per RECIST v1.1. PFS is defined as the time from first study drug infusion until the first evidence of disease progression or death.
- Overall Survival (OS) [From first study drug infusion until death or Month 24.]
Investigator assessed OS per RECIST v1.1. OS is defined as the time from first study drug infusion to death.
- Time to Progression (TTP) [From first study drug infusion until first evidence of disease progression or Month 24.]
Investigator assessed TTP per RECIST v1.1. TTP is defined as the time from first study drug infusion until first evidence of disease progression.
- Time to Treatment Response (TTR) [From first study drug infusion until first evidence of disease response or Month 24.]
Investigator assessed TTR per RECIST v1.1. TTR is defined as the time from first study drug infusion until first evidence of disease response.
- Disease Control Rate (DCR) [From first study drug infusion until first evidence of disease response or stable disease or Month 24.]
Investigator assessed DCR per RECIST v1.1 DCR is defined as the percentage of participants with complete response, partial response or stable disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed and dated informed consent form.
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Male or female, > 18 years old.
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Minimum body weight of 50 kilograms (kg).
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Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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Histologically or cytologically confirmed stage 4 metastatic NSCLC
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Progressed on at least 2 lines of SOC therapy including platinum-based chemotherapy and immune checkpoint inhibitors.
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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.
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At least one measurable target lesion based on RECIST v1.1
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All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1, except for continuing alopecia.
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Life expectancy of at least 6 months.
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Adequate hematopoietic, hepatic and renal function
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Agree to adequate contraception for up to 120 days after the last dose of study drug.
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Negative serum pregnancy test for women of childbearing potential
Exclusion Criteria:
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Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30 days prior to study Day 1.
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Major surgery, except for vascular access placement, within the 30 days prior to study Day 1.
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Active autoimmune disease requiring immunosuppressive therapy.
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Infection requiring systemic treatment within 30 days prior to study Day 1.
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History of peritoneal effusion (ascites), pericardial, or pleural effusions/nodules.
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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.
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Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C detection.
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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.
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Presence of any condition that may, in the opinion of the Investigator, render the patient inappropriate from participating in the study.
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Breastfeeding or pregnant female, or patient is expecting to conceive or father children during the study.
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Allergy or intolerance to any of the study product ingredients or excipients.
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Live vaccines administered within 30 days prior to study Day 1.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kiromic BioPharma Inc.
- Stiris Research Inc
- Statistics & Data Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DELTACEL-01