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CISH CRISPR TIL / Phase I Arm for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Comprehensive Cancer Center, Duarte, CANon-Small Cell Lung Cancer+5 MoreFludarabine - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new way to treat lung cancer using genetically-engineered immune cells. The goal is to see if this new treatment is safe and effective.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Adenocarcinoma
  • Stage IV Non-small Cell Lung Cancer
  • Squamous Cell Carcinoma of the Lung

Treatment Effectiveness

Effectiveness Progress

1 of 3

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uhCG/EGF
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Study Objectives

2 Primary · 6 Secondary · Reporting Duration: 3.5 years

11 months
Phase I: Safety and Initial Efficacy
2-5 years
Clinical Benefit Rate
Duration of Response (DoR)
Overall Survival (OS)
Progression Free Survival (PFS)
Toxicity Incidence
Tumor Growth Change
3.5 years
Phase II: Objective Response Rate (ORR)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
MOS Social Support Measure
1
uhCG/EGF
1
GT103

Trial Design

4 Treatment Groups

CISH CRISPR TIL / Phase I Arm
1 of 4
CISH CRISPR TIL / Phase II Arm PD-L1 Negative Cohort
1 of 4
CISH CRISPR TIL / Phase II Arm PD-L1 Positive Cohort
1 of 4
CISH CRISPR TIL plus pembrolizumab / Phase I Arm
1 of 4

Experimental Treatment

70 Total Participants · 4 Treatment Groups

Primary Treatment: CISH CRISPR TIL / Phase I Arm · No Placebo Group · Phase 1 & 2

CISH CRISPR TIL / Phase I ArmExperimental Group · 4 Interventions: Fludarabine, Cyclophosphamide, CISH Inactivated TIL, Aldesleukin · Intervention Types: Drug, Drug, Biological, Drug
CISH CRISPR TIL / Phase II Arm PD-L1 Negative CohortExperimental Group · 5 Interventions: Fludarabine, Cyclophosphamide, CISH Inactivated TIL, Pembrolizumab, Aldesleukin · Intervention Types: Drug, Drug, Biological, Drug, Drug
CISH CRISPR TIL / Phase II Arm PD-L1 Positive CohortExperimental Group · 5 Interventions: Fludarabine, Cyclophosphamide, CISH Inactivated TIL, Pembrolizumab, Aldesleukin · Intervention Types: Drug, Drug, Biological, Drug, Drug
CISH CRISPR TIL plus pembrolizumab / Phase I ArmExperimental Group · 5 Interventions: Fludarabine, Cyclophosphamide, CISH Inactivated TIL, Pembrolizumab, Aldesleukin · Intervention Types: Drug, Drug, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3920
Pembrolizumab
2017
Completed Phase 3
~2200
Aldesleukin
2012
Completed Phase 4
~1620

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3.5 years

Who is running the clinical trial?

Intima Bioscience, Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Emil Lou, MD, PhDPrincipal InvestigatorDivision of Hematology, Oncology, and Transplantation, University of Minnesota
1 Previous Clinical Trials
20 Total Patients Enrolled
Erminia Massarelli, MD, PhD, MSPrincipal InvestigatorDepartment of Medical Oncology & Therapeutics Research, City of Hope

Eligibility Criteria

Age 18 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between 18 and 70 years old to participate.
You have enough white blood cells (WBC) in your body (at least 3000 per cubic millimeter).
You must have a minimum of 75,000 platelets per cubic millimeter of blood.
You are able to perform daily activities without being limited by your medical condition and your doctor estimates that you will live for at least 6 more months.
You have been diagnosed with metastatic non-small cell lung cancer (NSCLC) and your PD-L1 status has been confirmed either negative or positive.
You have at least one tumor that can be surgically removed and used to make the cell therapy. You also have at least one other tumor that can be measured to determine the effectiveness of the treatment. The surgery to remove the tumor will depend on your specific situation and previous radiation treatment is not allowed.
You may have brain metastases, but they must be discussed with and approved by the study coordinator. If you have had stereotactic radiosurgery, your brain metastases must be stable for 1 month after treatment. You cannot be taking steroids for your brain metastases, but you can take oral progestin/estrogen for contraception. Your brain metastases will be assessed using the RANO-BM criteria.
Your absolute neutrophil count (a type of white blood cell) must be above 1000/mm^3 without using a medication called filgrastim.
Your hemoglobin level must be at least 8.0 g/dL. If it is too low, you may receive a blood transfusion to bring it up to the required level.
You are eligible for treatment with a certain type of immunotherapy combined with chemotherapy as your first line of treatment. Your tumor must be removed before starting this treatment. If you have already started treatment, the tumor removal procedure should be done as soon as possible but no later than 6 months (Phase 1) or 3 months (Phase 2) from the start of 1st line treatment. After this treatment, if your disease progresses, you may receive the investigational product as a second line of therapy.
References

Frequently Asked Questions

Does your research include individuals aged 55 or older?

"This research project is open to individuals aged 18 and over, up until the age of 75." - Anonymous Online Contributor

Unverified Answer

What criteria must one meet to partake in this clinical examination?

"This clinical trial is recruiting 70 individuals diagnosed with squamous cell carcinoma between the ages of 18 and 75. Applicants must meet a number of criteria, such as having confirmed histologic diagnosis for metastatic NSCLC (PD-L1 negative or positive) that can be treated with anti-PD-1/anti-PD-L1 immunotherapy plus chemotherapy, measurable disease per RECIST version 1.1., ECOG performance status 0 or 1, and more. Patients who have already started first line treatment are also eligible under certain conditions outlined in the requirements list." - Anonymous Online Contributor

Unverified Answer

Are new participants welcome to join this research endeavor?

"Data hosted on clinicaltrials.gov reveals that, as of September 30th 2022, this particular research trial has ceased its recruitment activities; it was initially posted to the website in November 1st 2022. Fortunately, there are 1946 other medical studies actively enrolling patients at the moment." - Anonymous Online Contributor

Unverified Answer

What are the key aims of this investigation?

"Intima Bioscience, Inc., the study sponsor has set a 3.5 year timeline to evaluate Phase 1 Safety and Initial Efficacy as their primary objective. Toxicity incidence, overall survival (Kaplan-Meier estimate), and duration of response are all secondary outcomes that will be measured by researchers during this period." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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