Trial record 2 of 2 for:
ATX-NS-001
ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04032847 |
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Recruitment Status :
Recruiting
First Posted : July 25, 2019
Last Update Posted : September 22, 2023
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Sponsor:
Achilles Therapeutics UK Limited
Information provided by (Responsible Party):
Achilles Therapeutics UK Limited
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Brief Summary:
This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterise the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Advanced Non Small Cell Lung Cancer | Biological: ATL001 Drug: Pembrolizumab | Phase 1 Phase 2 |
This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterise the safety and clinical activity of autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).
Patients will initially enter the study for procurement of tumour materials required to manufacture ATL001.
Following manufacture of ATL001, the product will be given back to eligible patients following lymphodepletion. Patients will continue to be followed up for a minimum of 5 years, as part of a separate Long Term Follow Up Protocol, or, if the separate protocol is not available at the study site, within this protocol.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients With Advanced Non-Small Cell Lung Cancer |
| Actual Study Start Date : | July 8, 2019 |
| Estimated Primary Completion Date : | July 31, 2025 |
| Estimated Study Completion Date : | July 31, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort A
Following lymphodepletion, infusion of cell therapy product ATL001.
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Biological: ATL001
ATL001 infusion |
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Experimental: Cohort B
Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor.
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Biological: ATL001
ATL001 infusion Drug: Pembrolizumab Checkpoint inhibitor |
Primary Outcome Measures :
- Assessment of Treatment Emergent Adverse Events (TEAEs) to evaluate Safety and Tolerability [ Time Frame: 84 months ]Evaluate TEAEs and serious AEs, by incidence, severity and relationship to ATL001
Secondary Outcome Measures :
- Disease Assessment for Change from Baseline in Tumour Size [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the clinical activity of ATL001 in patients with advanced NSCLC using change from baseline in tumour size at week 6 , week 12 and best overall change from baseline, as assessed by investigator and independent central review (ICR)
Other Outcome Measures:
- Disease Assessment for Objective Response Rate (ORR) [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the endpoint of ORR as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST).
- Disease Assessment for Time to Response (TTR) from ATL001 infusion [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the endpoint of TTR by the investigator and ICR, per RECIST v1.1 and im-RECIST
- 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 [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the endpoint of DOR by the investigator and ICR, per RECIST v1.1 and im-RECIST
- Disease Assessment for Disease Control Rate (DCR) [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the endpoints of DCR as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST
- Disease Assessment for Progression-Free Survival (PFS) [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate the efficacy endpoints of PFS as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST
- Overall Survival (OS) [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]Evaluate OS by the investigator
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient must be at least 18 years old.
- Patient must have given written informed consent.
- Patients must have confirmed diagnosis of non-small cell lung cancer that is considered to be smoking related.
- ECOG Performance Status 0-1.
- Anticipated life expectancy ≥ 6 months at the time of tissue procurement.
- Measurable disease according to RECIST 1.1 criteria.
- Adequate organ function per the laboratory parameters defined in the protocol.
- Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures.
- Female patients who are of childbearing potential must agree to use a highly effective method of contraception during the study for at least 12 months after the ATL001 infusion, and for at least 4 months after the last dose of pembrolizumab. Non-sterilised male participants who intend to be sexually active with a female partner of childbearing potential must use an acceptable method of contraception from the time of screening, throughout the duration of the study and for at least 6 months after the ATL001 infusion.
Additional Inclusion Criteria will apply as per the protocol.
Exclusion Criteria:
- 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 with hepatitis B or C, human immunodeficiency virus infection (HIV1/2), syphilis or HTLVI/II infection.
- Patients requiring immunosuppressive treatments.
- Patients requiring regular steroids at dose higher than prednisolone 10mg/day (or equivalent).
- Patients for whom there is documented evidence of an actionable tumour driver oncogene mutation (EGFR, ALK or ROS-1) at the time of initial screening. Patients who have progressed on standard targeted therapies, or for whom no approved targeted treatments are available, are not excluded.
- Patients with superior vena cava syndrome.
- Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.
- Patients who are pregnant or breastfeeding.
- Patients who have undergone major surgery in the previous 3 weeks.
- Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas, early prostate cancer with normal Prostate-Specific Antigen (PSA) or non-melanomatous skin cancers).
- Patients with a history of organ transplantation.
- Patients who have previously received any investigational cell or gene therapies.
- Patients with contraindications for protocol-specified agents.
- Patients with a history of immune mediated central nervous system toxicity, or a history of ≥ Grade 2 diarrhoea/colitis within the past 6 months caused by previous immunotherapy.
Additional Exclusion Criteria will apply as per the protocol.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032847
Contacts
| Contact: Clinical Operations Achilles Therapeutics | +44 (0)20 8154 4600 | info@achillestx.com |
Locations
Show 18 study locations
Sponsors and Collaborators
Achilles Therapeutics UK Limited
Investigators
| Study Director: | Medical Monitor, MD | Achilles Therapeutics |
| Responsible Party: | Achilles Therapeutics UK Limited |
| ClinicalTrials.gov Identifier: | NCT04032847 |
| Other Study ID Numbers: |
ATX-NS-001 |
| First Posted: | July 25, 2019 Key Record Dates |
| Last Update Posted: | September 22, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |