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| Name | Class |
|---|---|
| Stiris Research Inc | UNKNOWN |
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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.
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 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 21 additional participants in Part 2 of the study.
The total treatment period of the study drug protocol will be completed in 31 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 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KB-GDT-01 cells | Experimental | Dose Level 1: 400 x10^6, 800 x10^6 or 1600 x10^6 KB-GDT-01 cells + radiation (1.0 Gy/fraction) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KB-GDT-01 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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. | From first study drug infusion through to Month 24 |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Wagener, BS | Contact | 1-844-539-2873 | mwagener@kiromic.com | |
| Leonardo Mirandola, PhD | Contact | 1-844-539-2873 | lmirandola@kiromic.com |
| Name | Affiliation | Role |
|---|---|---|
| Jason J Luke, MD, FACP | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Cancer Center | Not yet recruiting | Tucson | Arizona | 85719 | United States |
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The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) or the maximum administered dose (MAD) will be determined based on isotonic regression in Part 1 Dose Escalation. If the MTD/MAD shows an acceptable safety and tolerability profile, an additional 12 participants in Part 2 expansion will be enrolled. Three dose levels of KB-GDT-01 will be evaluated and will follow a Bayesian Optimal Interval (BOIN) design rule based on a targeting rate of 25% for dose limiting toxicity (DLT) occurring between the first KB-GDT-01 infusion and Day 40. Depending on observed DLT rate, the safety monitoring committee will assess whether to escalate to the next dose, de-escalate (not applicable for the first dose), hold at current dose or stop the study if at the first dose.
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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. |
| From first study drug infusion until the first evidence of disease progression, death or Month 24. |
| Overall Survival (OS) | Investigator assessed OS per RECIST v1.1. OS is defined as the time from first study drug infusion to death. | From first study drug infusion until death or Month 24. |
| Time to Progression (TTP) | Investigator assessed TTP per RECIST v1.1. TTP is defined as the time from first study drug infusion until first evidence of disease progression. | From first study drug infusion until first evidence of disease progression or Month 24. |
| Time to Treatment Response (TTR) | Investigator assessed TTR per RECIST v1.1. TTR is defined as the time from first study drug infusion until first evidence of disease response. | From first study drug infusion until first evidence of disease response or Month 24. |
| Disease Control Rate (DCR) | Investigator assessed DCR per RECIST v1.1 DCR is defined as the percentage of participants with complete response, partial response or stable disease. | From first study drug infusion until first evidence of disease response or stable disease or Month 24. |
| Beverly Hills Cancer Center | Recruiting | Beverly Hills | California | 90211 | United States |
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| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| Texas Oncology - Tyler | Recruiting | Tyler | Texas | 75702 | United States |
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| Virginia Oncology Associates | Recruiting | Norfolk | Virginia | 23502 | United States |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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