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

NCT06069570 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: DELTACEL-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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 cancer or solid tumors with bone metastases to evaluate the safety and efficacy of combining immunotherapy with radiation therapy.

Conditions

Carcinoma, Non-Small-Cell Lung Cancer; Bone Metastases From Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  From first study drug infusion through to Month 24

• Progression Free Survival (PFS)

  From first study drug infusion until the first evidence of disease progression, death or Month 24.

• Overall Survival (OS)

  From first study drug infusion until death or Month 24.

• Time to Progression (TTP)

  From first study drug infusion until first evidence of disease progression or Month 24.

• Time to Treatment Response (TTR)

  From first study drug infusion until first evidence of disease response or Month 24.

Study Arms (1)

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)

Biological: KB-GDT-01

Interventions

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.

Also known as: Low dose radiotherapy

KB-GDT-01 cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kiromic BioPharma Inc.: lead
• Stiris Research Inc: collaborator

Study Sites (5)

The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

NOT YET RECRUITING

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma; Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jason J Luke, MD, FACP

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Wagener, BS

CONTACT

1-844-539-2873; mwagener@kiromic.com

Leonardo Mirandola, PhD

CONTACT

1-844-539-2873; lmirandola@kiromic.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: October 6, 2023
• Study Start: November 7, 2023
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

US (5)