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CAR T-cell Therapy
ATL001 + Pembrolizumab for Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Achilles Therapeutics UK Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be at least 18 years old
Patients must have confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Awards & highlights
Study Summary
This trial will study the safety and activity of a new treatment for advanced non-small cell lung cancer. The treatment involves taking T cells from the patient, modifying them to recognize and attack cancer cells, and then giving them back to the patient intravenously.
Who is the study for?
Adults with advanced NSCLC related to smoking, who are medically fit for the treatment procedures and have a life expectancy of at least 6 months. They must not be pregnant or breastfeeding, have untreated brain metastases, major organ dysfunction, certain viral infections (like hepatitis B/C or HIV), history of severe immune reactions or other cancers in the past 3 years. Contraception is required.Check my eligibility
What is being tested?
The trial is testing ATL001 (clonal neoantigen reactive T cells) combined with Pembrolizumab in patients with advanced NSCLC. It's an early-phase study assessing safety and how well these treatments work when given intravenously.See study design
What are the potential side effects?
Potential side effects may include typical immune therapy-related issues such as inflammation in various organs, infusion reactions like fever or chills, fatigue, possible worsening of underlying diseases due to immune system activation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My lung cancer is related to smoking.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks for 6 months, then every 3 months for a maximum of 84 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Treatment Emergent Adverse Events (TEAEs) to evaluate Safety and Tolerability
Secondary outcome measures
Disease Assessment for Change from Baseline in Tumour Size
Other outcome measures
Disease Assessment for Disease Control Rate (DCR)
Disease Assessment for Duration of Response (DoR). The DoR is defined as the time from the date of first documented response until the date of documented disease progression or death
Disease Assessment for Objective Response Rate (ORR)
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort BExperimental Treatment2 Interventions
Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor.
Group II: Cohort AExperimental Treatment1 Intervention
Following lymphodepletion, infusion of cell therapy product ATL001.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Achilles Therapeutics UK LimitedLead Sponsor
3 Previous Clinical Trials
441 Total Patients Enrolled
Medical Monitor, MDStudy DirectorAchilles Therapeutics
72 Previous Clinical Trials
18,026 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain metastases are stable and I don't need steroids.You have received experimental cell or gene treatments before.I am 18 years old or older.My lung cancer is related to smoking.I agree to use effective birth control during and after the study for the required time.My cancer has a specific gene change but standard treatments haven't worked or aren't available.I had major surgery less than 3 weeks ago.I have had an organ transplant.I have not had any cancer except for specific low-risk types in the past 3 years.I am a man who will use birth control during and 6 months after the study if I have sex with a woman who can get pregnant.I am fully active or can carry out light work.I do not have any uncontrolled major organ or system diseases.I am medically cleared for the procedure to collect cells and receive ATL001 treatment.I need medication to suppress my immune system.I have hepatitis B or C, HIV, syphilis, or HTLV.I've had severe reactions to previous immunotherapy, including brain issues or serious diarrhea.I have superior vena cava syndrome.My organs are functioning well according to recent tests.I take more than 10mg/day of steroids regularly.You have a measurable disease that can be evaluated using specific criteria called RECIST 1.1.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being accepted to participate in this research?
"Yes, this clinical trial is still recruiting patients. The information on the website was last updated on September 14th, 2021 and the study was originally posted on July 8th, 2019."
Answered by AI
Why is ATL001 prescribed to patients?
"ATL001 is a medication that oncologists prescribe to fight cancerous neoplasms. It can also be used to treat conditions like unresectable melanoma, microsatellite instability high, and chemotherapy-resistance."
Answered by AI
Are there any sites running this clinical trial in the United States?
"There are 5 sites currently recruiting patients. Some notable locations include Yale University School of Medicine, Duke University Medical Center, and H Lee Moffitt Cancer Center and Research Unit."
Answered by AI
Are there similar experimental treatments to ATL001?
"There are currently one thousand ongoing clinical trials evaluating the efficacy of ATL001. 122 of those trials have advanced to Phase 3 testing. Although Houston, Texas has the most number of trial sites for this medication, there are 36027 locations running studies worldwide."
Answered by AI
How many people are being allowed to participate in this research?
"In order to progress, this trial needs 50 individuals that fit the given description. These patients can be sourced from different locations, such as Yale University School of Medicine or Duke University Medical Center."
Answered by AI
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