Trial Title:
Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC
NCT ID:
NCT06069570
Condition:
Carcinoma, Non-Small-Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
KB-GDT-01
Description:
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.
Arm group label:
KB-GDT-01 cells
Other name:
Low dose radiotherapy
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.
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
Criteria for 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 stage 4 metastatic NSCLC
- Progressed on at least 2 lines of SOC therapy including platinum-based chemotherapy
and immune checkpoint inhibitors.
- 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
- All toxicity associated with previous treatments are recovered to CTCAE grade of ≤1,
except for continuing alopecia.
- Life expectancy of at least 6 months.
- 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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Arizona Cancer Center
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mikayla Kirby
Phone:
520-621-9656
Email:
mikaylakirby@arizona.edu
Contact backup:
Last name:
Margaret Ramirez
Phone:
(520) 626-3677
Email:
ramirezm1@arizona.edu
Investigator:
Last name:
Ricklie Julian, MD
Email:
Principal Investigator
Facility:
Name:
Beverly Hills Cancer Center
Address:
City:
Beverly Hills
Zip:
90211
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ali Muhammad
Phone:
310-432-8934
Email:
amuhammad@bhcancercenter.com
Investigator:
Last name:
Afshin Gabayan, MD
Email:
Principal Investigator
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
IDDC Referrals
Phone:
878-261-6063
Email:
IDDCReferrals@upmc.edu
Investigator:
Last name:
Jason Luke, MD
Email:
Principal Investigator
Facility:
Name:
Texas Oncology - Tyler
Address:
City:
Tyler
Zip:
75702
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Castner
Phone:
903-579-9800
Email:
Jennifer.castner@usoncology.com
Investigator:
Last name:
Donald Richards, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Virginia Oncology Associates
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Recruiting
Contact:
Last name:
Karen McClain
Phone:
757-213-5658
Email:
Karen.mcclain@usoncology.com
Investigator:
Last name:
Gary Simmons, DO, MSHA
Email:
Principal Investigator
Start date:
November 7, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
Kiromic BioPharma Inc.
Agency class:
Industry
Collaborator:
Agency:
Stiris Research Inc
Agency class:
Other
Collaborator:
Agency:
Statistics & Data Corporation
Agency class:
Industry
Source:
Kiromic BioPharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06069570
