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CAR T-cell Therapy

KB-GDT-01 cells 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

Study Summary

This trial studies how well a combination of radiation + immunotherapy works to treat lung cancer.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program open to enrollees at this time?

"Affirmative. According to clinicaltrials.gov, this medical investigation which was originally posted on November 7th 2023 is currently recruiting individuals for participation. The study requires 48 patients across 2 sites and the details were last updated December 11th of the same year."

Answered by AI

How many participants have been included in this research study?

"Indeed, per clinicaltrials.gov the trial is presently enrolling patients. Originally posted on November 7th 2023 and last updated December 11th 2023, 48 participants are required from 2 designated sites."

Answered by AI

To what extent do KB-GDT-01 cells pose a risk to humans?

"As KB-GDT-01 cells are currently in their first phase of clinical trials, the safety rating is estimated to be 1 due to limited data demonstrating efficacy and patient security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC

2023. "Safety Study for a Gamma Delta T Cell Product Used With Low Dose Radiotherapy in Patients With Stage 4 Metastatic NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06069570.

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