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

Last updated: March 3, 2025
Sponsor: Kiromic BioPharma Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasm Metastasis

Treatment

KB-GDT-01

Clinical Study ID

NCT06069570
DELTACEL-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orlocally advanced or metastatic solid tumor with bone metastasis

  • Progressed on SOC therapy including platinum-based chemotherapy and immunecheckpoint inhibitors (NSCLC), and are not a candidate for further standardanti-neoplastic therapy and/or have exhibited intolerance to and/or declinedclinically applicable salvage therapies, and/or have declined therapy.

  • Genomic screening, with tumors with known actionable molecular alterations, such asEGFR, ALK, ROS-1, BRAF, RET, MET, and KRAS etc., must have progressed on appropriatetarget-directed molecular therapy.

  • At least one measurable target lesion based on RECIST v1.1 confirmed by radiologicalimaging. Participants with isolated bone metastases are eligible for enrollment arenot 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 studydrug.

  • 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): receivingzoledronic acid for solid tumors with bone metastases

Exclusion

Exclusion Criteria:

  • Chemotherapy, investigational, and/or check-point inhibitor therapy within the 30days prior to study Day 1.

  • Major surgery, except for vascular access placement, within the 30 days prior tostudy 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 clinicaltrial 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 thepatient inappropriate from participating in the study.

  • Breastfeeding or pregnant female, or patient is expecting to conceive or fatherchildren 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

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: KB-GDT-01
Phase: 1
Study Start date:
November 07, 2023
Estimated Completion Date:
October 31, 2026

Study Description

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.

Connect with a study center

  • The University of Arizona Cancer Center

    Tucson, Arizona 85719
    United States

    Site Not Available

  • Beverly Hills Cancer Center

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Beverly Hills Cancer Center & Optima Diagnostic Imaging

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Texas Oncology - Tyler

    Tyler, Texas 75702
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

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