Trial Outcomes & Findings for ATL001 in Patients With Metastatic or Recurrent Melanoma (NCT NCT03997474)

Last Updated: 2025-03-07

Results Overview

Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

60 months due to early termination

Results posted on

2025-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion	Cohort B Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab	Cohort C Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion
Overall Study STARTED	9	2	2
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	9	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion	Cohort B Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab	Cohort C Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion
Overall Study Death	6	2	1
Overall Study Physician Decision	2	0	0
Overall Study study terminated by sponsor	1	0	1

Baseline Characteristics

ATL001 in Patients With Metastatic or Recurrent Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A n=9 Participants Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion	Cohort B n=2 Participants Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab	Cohort C n=2 Participants Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	50.4 years STANDARD_DEVIATION 10.49 • n=5 Participants	59.5 years STANDARD_DEVIATION 4.95 • n=7 Participants	36.5 years STANDARD_DEVIATION 4.95 • n=5 Participants	49.7 years STANDARD_DEVIATION 11.09 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United Kingdom	9 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment Spain	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Body mass index (kg/m^2)	28.52 kg/m^2 STANDARD_DEVIATION 4.922 • n=5 Participants	25.55 kg/m^2 STANDARD_DEVIATION 2.052 • n=7 Participants	22.90 kg/m^2 STANDARD_DEVIATION 1.838 • n=5 Participants	27.2 kg/m^2 STANDARD_DEVIATION 4.651 • n=4 Participants
Baseline ECOG performance status Grade 0	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Baseline ECOG performance status Grade 1	7 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: 60 months due to early termination

Evaluate treatment-emergent adverse events (TEAEs) and serious AEs, per CTCAE, by incidence, severity and relationship to ATL001

Outcome measures

Outcome measures
Measure	Cohort A n=9 Participants Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion	Cohort B n=2 Participants Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab	Cohort C n=2 Participants Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Serious ATL001 related TEAEs	1 Participants	1 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Serious IL-2 related TEAEs	1 Participants	1 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE TEAEs with CTCAE grade >= 3	6 Participants	2 Participants	1 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE TEAEs with CTCAE grade >= 3 related to any component of study treatment	5 Participants	2 Participants	1 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE TEAEs	9 Participants	2 Participants	2 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE TEAEs related to any component of study treatment	8 Participants	2 Participants	2 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Lymphodepletion related TEAEs	8 Participants	1 Participants	2 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE ATL001 related TEAEs IL-2 related TEAEs Serious TEAEs	5 Participants	2 Participants	2 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE IL-2 related TEAEs	7 Participants	2 Participants	2 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Nivolumab related TEAEs	0 Participants	0 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Serious TEAEs	3 Participants	1 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Serious TEAEs related to any component of study treatment	1 Participants	1 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Serious Lymphodepletion related TEAEs	0 Participants	0 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Serious Nivolumab related TEAEs	0 Participants	0 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Lymphodepletion related TEAEs with CTCAE grade >= 3	4 Participants	1 Participants	1 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE ATL001 related TEAEs with CTCAE grade >= 3	2 Participants	1 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE IL-2 related TEAEs with CTCAE grade >= 3	2 Participants	2 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE Nivolumab related TEAEs with CTCAE grade >= 3	0 Participants	1 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE TEAEs leading to death	0 Participants	1 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE TEAEs leading to death related to any component of study treatment	0 Participants	0 Participants	0 Participants
Assessment of Treatment Emergent Adverse Events to Evaluate Safety and Tolerability: CTCAE SAEs	3 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 6 weeks for 6 months, then every 3 months (up to 60 months due to early study termination)

Evaluate the endpoint of overall 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). RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) is a standardized system for measuring tumor response to treatment in clinical trials. Tumors are assessed by imaging (e.g., CT or MRI) based on changes in size. Responses are categorized as: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% reduction in the sum of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD). Progressive Disease (PD): ≥20% increase in the sum of target lesions, or appearance of new lesions. These criteria help assess the efficacy of treatments in solid tumors supported by im-RECIST in immunotherapy.

Outcome measures

Outcome measures
Measure	Cohort A n=9 Participants Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion	Cohort B n=2 Participants Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab	Cohort C n=2 Participants Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion
Disease Assessment for Overall Response Rate Responders	0 Participants	0 Participants	0 Participants
Disease Assessment for Overall Response Rate Non-Responders	9 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 6 weeks for 6 months, then every 3 months for a maximum of 84 months

Evaluate overall survival (OS) by investigator

Outcome measures

Outcome data not reported

Adverse Events

Cohort A

Serious events: 3 serious events

Other events: 9 other events

Deaths: 8 deaths

Cohort B

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Cohort C

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A n=9 participants at risk Following lymphodepletion, infusion of cell therapy product ATL001, followed by a low dose regimen of IL- 2. ATL001: ATL001 infusion	Cohort B n=2 participants at risk Following lymphodepletion, infusion of cell therapy product ATL001 in combination with a checkpoint inhibitor, followed by a low dose regimen of IL-2. ATL001: ATL001 infusion Checkpoint Inhibitor: Nivolumab	Cohort C n=2 participants at risk Following lymphodepletion, infusion of cell therapy product ATL001, followed by a higher dose regimen of IL-2. ATL001: ATL001 infusion
Injury, poisoning and procedural complications Procedural pain	0.00% 0/9 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	50.0% 1/2 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Infections and infestations Abdominal wall infection	11.1% 1/9 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Nervous system disorders Immune effector cell-associated neurotoxicity syndrome	11.1% 1/9 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	50.0% 1/2 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Infections and infestations Sepsis	22.2% 2/9 • Number of events 2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Infections and infestations Klebsiella sepsis	11.1% 1/9 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Gastrointestinal disorders Constipation	11.1% 1/9 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Injury, poisoning and procedural complications Drain site complication	11.1% 1/9 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Renal and urinary disorders Haematuria	11.1% 1/9 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Gastrointestinal disorders Colitis ischaemic	11.1% 1/9 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Endocrine disorders Adrenal insufficiency	0.00% 0/9 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	50.0% 1/2 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).
Infections and infestations Pneumonia aspiration	0.00% 0/9 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	50.0% 1/2 • Number of events 1 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).	0.00% 0/2 • Each patient that received ATL001 would have been followed up for 24 months, to withdrawal of consent or death. Patients would then continue to be followed up for a minimum of 5 years as part of long term follow up. The study was terminated early due to sponsor decision. The Median follow-up period was 12 weeks (range: 3 - 48 weeks).

Other adverse events

Additional Information

Dr Matilde Saggese

Achilles Therapeutics UK Limited

Phone: 0786 9814607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Range of other disclosure agreements across study sites. Following multi-center publication of the Study results made by Sponsor, the Institution and/or Principal Investigator may publish data or results from the Study provided the Sponsor is given 45 to 90 days to review and/or make comments and suggestions where pertinent.
Publication restrictions are in place

Restriction type: OTHER