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CAR T-cell Therapy
Immunotherapy + Radiotherapy for Non-Small Cell Lung Cancer
Phase 1
Recruiting
Led By Jason J Luke, MD, FACP
Research Sponsored by Kiromic BioPharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed stage 4 metastatic NSCLC
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first study drug infusion through to month 24
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new treatment for advanced lung cancer using special immune cells from healthy donors and a small amount of radiation. The goal is to see if this combination is safe and effective. The immune cells help the body fight cancer, and the radiation makes the cancer cells easier to attack.
Who is the study for?
This trial is for adults over 18 with stage 4 metastatic non-small cell lung cancer (NSCLC) who have tried at least two standard treatments, including chemo and immunotherapy. They must weigh at least 50 kg, be fairly active (ECOG status of 0-1), and have a life expectancy of more than six months. Those with certain genetic changes in their tumors should have also tried targeted therapies.
What is being tested?
The study tests KB-GDT-01, an infusion of immune cells called gamma delta T cells, given after low dose radiotherapy to see if it's safe and works well together with radiation to treat NSCLC. The goal is to find out how patients respond to this combination therapy.
What are the potential side effects?
Potential side effects may include typical reactions from infusions such as fever or chills, fatigue due to the immune system activation by the T cells, and skin irritation or other localized issues from radiotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at stage 4 and has been confirmed by tests.
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My cancer, with specific genetic changes, has not improved despite targeted treatment.
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I weigh at least 50 kilograms.
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I am fully active or can carry out light work.
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My cancer has worsened despite receiving at least two standard treatments, including platinum chemotherapy and immunotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first study drug infusion through to month 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first study drug infusion through to month 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Overall Survival (OS)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: KB-GDT-01 cellsExperimental Treatment1 Intervention
Dose Level 1: 400 x10\^6, 800 x10\^6 or 1600 x10\^6 KB-GDT-01 cells + radiation (1.0 Gy/fraction)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy, targeted therapy, and chemotherapy. Immunotherapy, such as PD-1/PD-L1 inhibitors, works by activating the immune system to recognize and destroy cancer cells, which is crucial for patients as it offers a way to harness the body's natural defenses.
Targeted therapies, like EGFR or ALK inhibitors, block specific molecules involved in cancer cell growth and survival, providing a more personalized treatment approach that can be highly effective for patients with certain genetic mutations. Chemotherapy, using drugs like cisplatin and etoposide, kills rapidly dividing cells, including cancer cells, and is often used in combination with other treatments to enhance efficacy.
The study of Allogeneic Gamma Delta T Cells aims to activate the immune system and directly kill cancer cells, similar to immunotherapy, offering a promising avenue for enhancing the body's ability to fight NSCLC.
Find a Location
Who is running the clinical trial?
Kiromic BioPharma Inc.Lead Sponsor
4 Previous Clinical Trials
3 Total Patients Enrolled
Stiris Research IncUNKNOWN
Statistics & Data CorporationIndustry Sponsor
4 Previous Clinical Trials
1,009 Total Patients Enrolled
Jason J Luke, MD, FACPPrincipal InvestigatorUniversity of Pittsburgh