Recruiting
Phase 1

Gamma Delta T Cells

Sponsor:

Kiromic BioPharma Inc.

Code:

NCT06069570

Conditions

Carcinoma, Non-Small-Cell Lung Cancer

Bone Metastases From Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KB-GDT-01

Study Details

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

Study ID

NCT06069570

Start date

Nov 7, 2023

Status verified date

Mar, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

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.
  • 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.

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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)

Interventions

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.

Primary outcome measure

  • 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 [ Time Frame: From the first infusion of study drug until Day 40 or 30 days after the last study drug infusion, whichever occurs later ]

Central Contacts and Locations

Central contacts

Matthew Wagener, BS

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

Leonardo Mirandola, PhD

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

Locations

Beverly Hills Cancer Center

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Ali Muhammad

(310) 432-8934amuhammad@bhcancercenter.com

Principal Investigator:

Afshin Gabayan, MD

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

IDDC Referrals

(878) 261 6063IDDCReferrals@upmc.edu

Principal Investigator:

Jason Luke, MD

Texas Oncology - Tyler

Recruiting

Tyler, Texas, United States, 75702

Contacts

Jennifer Castner

(903) 579-9800Jennifer.castner@usoncology.com

Principal Investigator:

Donald Richards, MD, PhD

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Karen McClain

(757) 213-5658Karen.mcclain@usoncology.com

Principal Investigator:

Gary Simmons, DO, MSHA

More Information

Sponsor

Kiromic BioPharma Inc.

Last update posted

Mar 5, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kiromic BioPharma Inc. on 2025-03-05.