Antineoplastic Immune Cell for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope Comprehensive Cancer Center, Duarte, CA
Lung Cancer+13 More
Antineoplastic Immune Cell - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase I trial studies the side effects and best dose of COH06 with or without atezolizumab in patients with non-small cell lung cancer previously treated with PD-1 and/or PD-L1 immune checkpoint inhibitors that has spread to other places in the body (advanced) and that has not responded to previous treatment (refractory). NK cells are infection fighting blood cells that can kill tumor cells. The NK cells given in this study, COH06, will come from umbilical cord blood and will have a new gene put in them that makes them express PD-L1, and express and secrete IL-15. NK cells that express PD-L1 may kill more tumor cells, and IL-15 may allow the NK cells to live longer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving COH06 without or without atezolizumab may help control the disease in patients with non-small cell lung cancer.

Eligible Conditions

  • Lung Cancer
  • Stage IIIC Lung Cancer AJCC v8
  • Metastatic Lung Non-Small Cell Carcinoma
  • Stage IVA Lung Cancer AJCC v8
  • Recurrent Non-Small Cell Lung Carcinoma
  • Refractory Lung Non-Small Cell Carcinoma
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Advanced Non-Small Cell Lung Carcinoma
  • Stage IVB Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lung Cancer

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Year 2
Overall Survival (OS)
Year 2
Progression-Free Survival (PFS)
Up to 2 years
Disease Control Rate (DCR)
Incidence of adverse events - ASTCT
Incidence of adverse events - CTCAE
Overall Response Rate (ORR)
Day 28
Dose limiting toxicities

Trial Safety

Safety Progress

1 of 3

Other trials for Lung Cancer

Trial Design

1 Treatment Group

Treatment (fludarabine, cyclophosphamide, COH06, atezolizumab)
1 of 1
Experimental Treatment

21 Total Participants · 1 Treatment Group

Primary Treatment: Antineoplastic Immune Cell · No Placebo Group · Phase 1

Treatment (fludarabine, cyclophosphamide, COH06, atezolizumab)Experimental Group · 5 Interventions: Atezolizumab, Fludarabine, Cyclophosphamide, Biospecimen Collection, Antineoplastic Immune Cell · Intervention Types: Biological, Drug, Drug, Procedure, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2015
Completed Phase 4
~6340
Fludarabine
2012
Completed Phase 2
~1240
Cyclophosphamide
1995
Completed Phase 3
~4020
Biospecimen Collection
2004
Completed Phase 1
~430

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: City of Hope Comprehensive Cancer Center · Duarte, CA
Photo of Duarte  1Photo of Duarte  2Photo of Duarte  3
2011First Recorded Clinical Trial
0 TrialsResearching Lung Cancer
297 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have provided informed consent of the participant and/or legally authorized representative.
You have previously received a PD-1 or PD-L1 immune checkpoint inhibitor, either as single agent or in combination with chemotherapy or other immunotherapy or experimental agents.
You have received a PD-1/PD-L1 immune checkpoint inhibitor therapy for a cancer that is not metastatic and is not associated with another serious medical condition.
You have no cytotoxic chemotherapy or immunotherapy over the three weeks prior to lymphodepletion.
Measurable disease as per RECIST criteria 1.1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.