Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T-Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer or Solid Tumors With Bone Metastases

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
The University of Arizona Cancer Center
NOT_YET_RECRUITING
Tucson
California
Beverly Hills Cancer Center
RECRUITING
Beverly Hills
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Texas
Texas Oncology - Tyler
RECRUITING
Tyler
Virginia
Virginia Oncology Associates
RECRUITING
Norfolk
Contact Information
Primary
Matthew Wagener, BS
mwagener@kiromic.com
1-844-539-2873
Backup
Leonardo Mirandola, PhD
lmirandola@kiromic.com
1-844-539-2873
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2026-10
Participants
Target number of participants: 48
Treatments
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)
Sponsors
Collaborators: Stiris Research Inc
Leads: Kiromic BioPharma Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials