Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC

Kiromic

Status and phase

Enrolling

Phase 1

Conditions

Carcinoma, Non-Small-Cell Lung Cancer

Treatments

Biological: KB-GDT-01

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06069570

DELTACEL-01

Details and patient eligibility

About

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.

Full 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

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.