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ATL001 in Patients With Metastatic or Recurrent Melanoma

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ClinicalTrials.gov Identifier: NCT03997474
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Achilles Therapeutics Ltd

Brief Summary:
This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeTs) administered intravenously in adults with metastatic or recurrent melanoma.

Condition or disease Intervention/treatment Phase
Melanoma Biological: ATL001 Phase 1 Phase 2

Detailed Description:

This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeTs) administered intravenously in adults with metastatic or recurrent melanoma.

Patients will be screened for eligibility and consented to the study. Following donation and subsequent manufacture of ATL001, the product will be given back to eligible patients following lymphodepletion. Patients will be followed up for a period of 24 months post ATL001 infusion. After 2 years each patient will continue to be followed for a further 5 years as part of separate Long Term Follow-Up protocol.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group 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 Metastatic or Recurrent Melanoma
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Arm 1
Infusion of ATL001
Biological: ATL001
ATL001 infusion




Primary Outcome Measures :
  1. Assessment of Treatment Emergent Adverse Events to evaluate Safety and Tolerability: CTCAE v 4.0 [ Time Frame: Maximum 84 month ]
    Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE v 4.0, by incidence, severity and relationship to ATL001


Secondary Outcome Measures :
  1. 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 recurrent or metastatic melanoma 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).

  2. Disease Assessment for Objective Response Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the endpoint of objective response rate (ORR), as assessed by investigator and ICR, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune modified RECIST( im-RECIST).

  3. Disease Assessment for Time to Response and Duration of Response [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the endpoints of time to response and duration of response (DOR) by the investigator and ICR, per RECIST v1.1 and im-RECIST.

  4. Disease Assessment for Disease Control Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the endpoints of disease control rate (DCR) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.

  5. Disease Assessment for Progression-Free Survival [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months ]
    Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the investigator and ICR per RECIST v1.1 and im-RECIST.

  6. Overall survival [ Time Frame: Until death up to 84 months ]
    Evaluate overall survival (OS) by 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:

  1. Patient must be at least 18 years old.
  2. Patient must have given written informed consent.
  3. Confirmed diagnosis of melanoma.
  4. ECOG Performance Status 0-1.
  5. Patient is considered medically fit to undergo procurement of starting material and ATL001 administration procedures.
  6. Patient is considered, in the opinion of the investigator, capable of adhering to the protocol.
  7. Adequate organ function.
  8. Patients must have received a PD-1 inhibitor prior to treatment with ATL001
  9. Female patients who are of childbearing potential must agree to use a highly effective method of contraception
  10. Patients with female partners of childbearing potential must agree to use adequate contraception for at least 6 months after the ATL001 infusion
  11. Anticipated life expectancy ≥ 6 months.
  12. Patient must have measurable disease according to RECIST v1.1

Exclusion Criteria:

  1. Patients with known leptomeningeal or CNS metastases.
  2. Patients with ocular melanoma.
  3. Patients with active infectious disease
  4. Patients requiring immunosuppressive treatments.
  5. Patients requiring regular treatment with systemic steroids
  6. Patients with clinically significant, progressive, and/or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, gastroenterological or neurological disease.
  7. Patients who are pregnant or breastfeeding
  8. Patients who have undergone major surgery in the previous 3 weeks
  9. Patients with an active concurrent cancer or a history of cancer within the past 3 years (except for in situ carcinomas or non-melanomatous skin cancers)
  10. Patients with a history of organ transplantation.
  11. Patients who have received any investigational cell or gene therapies
  12. Patients with contraindications for protocol specified agents

Additional exclusion criteria may apply to define procedures within 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): NCT03997474


Contacts
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Contact: VP, Clinical Operations Achilles Therapeutics, PhD +44(0)1438 906 855 info@achillestx.com

Sponsors and Collaborators
Achilles Therapeutics Ltd
Investigators
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Study Director: Medical Monitor, MD Achilles Therapeutics

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Responsible Party: Achilles Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT03997474     History of Changes
Other Study ID Numbers: ATX-ME-001
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas