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CAR T-cell Therapy

ATL001 + Pembrolizumab for Lung Cancer

Phase 1 & 2

Waitlist Available

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

Must not have

Patients with untreated, symptomatic or progressing CNS metastases. Lesions should be clinically and radiologically stable for 2 months after treatment and should not require steroids

Patients who have undergone major surgery in the previous 3 weeks

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

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 below

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I am 18 years old or older.

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My lung cancer is related to smoking.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain metastases are stable and I don't need steroids.

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I had major surgery less than 3 weeks ago.

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I have had an organ transplant.

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I do not have any uncontrolled major organ or system diseases.

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I need medication to suppress my immune system.

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I have hepatitis B or C, HIV, syphilis, or HTLV.

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I have superior vena cava syndrome.

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I take more than 10mg/day of steroids regularly.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks for 6 months, then every 3 months for a maximum of 84 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of Treatment Emergent Adverse Events (TEAEs) to evaluate Safety and Tolerability

Secondary study objectives

Disease Assessment for Change from Baseline in Tumour Size

Other study objectives

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 more

Awards & Highlights

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.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment1 Intervention

Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2.

Group II: Cohort BExperimental Treatment2 Interventions

Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL- 2.

Group III: Cohort AExperimental Treatment1 Intervention

Following lymphodepletion with enhanced host conditioning, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

0 / 11Eligibility criteria met