What side effects are associated with this type of intervention?

Common treatments for NSCLC, such as immunotherapy and chemotherapy, have distinct side effect profiles. Immunotherapy, including agents like pembrolizumab and durvalumab, can cause fatigue, nausea, increased liver function tests, diarrhea, pneumonitis, rash, and pruritus. Severe adverse events may include pneumonia and other immune-related effects requiring immunosuppressive treatment. Chemotherapy, often combined with immunotherapy, can lead to side effects such as fatigue, nausea, vomiting, hair loss, and increased risk of infection due to bone marrow suppression. Both treatment types aim to enhance the immune system's ability to target cancer cells but come with a range of potential toxicities.

What prior FDA approvals exist?

Several immunotherapies and targeted therapies have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, an anti-PD-1 antibody, is approved for use in combination with chemotherapy for advanced NSCLC, showing improved overall survival and progression-free survival. Nivolumab, another anti-PD-1 antibody, is approved for use after progression on platinum-based chemotherapy. Atezolizumab, an anti-PD-L1 antibody, is approved for use in combination with chemotherapy for first-line treatment of metastatic NSCLC. Additionally, targeted therapies like osimertinib for EGFR mutations and sotorasib for KRAS G12C mutations have also been approved. These treatments focus on enhancing the immune system's ability to target and kill cancer cells, similar to the investigational approach of using Allogeneic Gamma Delta T Cells.

What other types of research exist?

Promising novel alternatives for NSCLC treatment in 2024 include: 1) PD-1/PD-L1 inhibitors such as pembrolizumab and nivolumab, which have shown improved overall survival and progression-free survival in clinical trials. 2) Combination therapies like pembrolizumab with chemotherapy (e.g., carboplatin and paclitaxel) have demonstrated significant benefits. 3) Anti-PD-1 inhibitors like tislelizumab and sintilimab, which have shown improved progression-free survival when combined with chemotherapy. 4) Agents targeting high tumor mutational burden (TMB), such as durvalumab plus tremelimumab, which have shown efficacy in patients with high TMB. These alternatives offer various mechanisms of action and potential benefits for NSCLC patients.

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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

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first study drug infusion through to month 24 for reporting.

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 more

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)

0 / 5Eligibility criteria met

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.

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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

~0 spots leftby Oct 2024

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