Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell TherapyPhase 2NCT03628612
Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
A Phase 2 study testing AUTO CAR T cell therapy in people with Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy and Multiple Myeloma, run by Autolus Limited at 9 sites in 3 countries.
Trial summary
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, Multiple Myeloma, DLBCL
- What is being tested?
- AUTO CAR T cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 2 Aug 2018to Dec 2043
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
- Patients must have provided informed consent for long-term follow-up study prior to participation.
- Patients must be able to comply with the study requirements.
Who cannot join
- There are no specific exclusion criteria for this study.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
United Kingdom5 sites
Queen Elizabeth University Hospital
Glasgow
University College London Hospitals NHS Foundation Trust
London
Manchester Royal Infirmary Hospital
Manchester
Royal Manchester Children's Hospital
Manchester
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
United States3 sites
St David's South Austin Medical Center
Austin, Texas, 78704
University of Miami
Miami, Florida, 33136
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
Read the detailed description
The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.
- Conditions
- Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, Multiple Myeloma, DLBCL, ALL, Adult and Pediatric, T Cell Lymphoma
- Being tested
- AUTO CAR T cell therapy
- Medical subject headings
- Multiple Myeloma, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUTO CAR T cell therapyBiological
No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.
| Study group | Role | What they receive |
|---|---|---|
| AUTO CAR T cell therapy | Experimental | Patients who received previous treatment with AUTO CAR T Cell Therapy Receives: Biological: AUTO CAR T cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy
Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy.
Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion.
Measured: For up to 15 years
Secondary outcomes (7)
Overall Survival following first AUTO CAR T cell therapy infusion.
Overall Survival following first AUTO CAR T cell therapy infusion.
Measured: For up to 15 years
Duration of supportive care
B-cell aplasia for patients treated with an AUTO CAR T cell therapy targeting a B-cell malignancy.
Measured: For up to 15 years
Duration of response
Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression.
Measured: For up to 15 years
Progression-free survival
Progression free survival following first AUTO CAR T cell therapy infusion.
Measured: For up to 15 years
Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion
Monitor for the absence of detectable RCR or RCL after the first AUTO CAR T cell therapy infusion
Measured: For up to 15 years
Proportion of patients with detectable vector copy number (VCN) in peripheral blood
Blood sample collection for VCN measurement to detect persistence of CAR transgene(s)
Measured: For up to 15 years
Testing for Insertional mutagenesis in case of a new malignancy
Insertional site analysis of samples to determine insertional mutagenesis as a potential cause / contributor in case of a new malignancy.
Measured: For up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start2 Aug 2018
- Primary completionJul 2043 (estimated)
- Study completionDec 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autolus Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628612
- Sponsor's protocol ID
- AUTO-LT1
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2018
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Patients Previously Treated With Autologous T Cells Genetically Modified With Viral Vectors
- ClinicalTrials.gov ID
- NCT03628612
- Acronym / sponsor ID
- AUTO-LT1
- Conditions
- Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, Multiple Myeloma, DLBCL, ALL, Adult and Pediatric, T Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Autolus LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- Jul 2043 (estimated)
- Study completion
- Dec 2043 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long-term follow-up of patients exposed to an AUTO CAR T cell therapy for up to 15 years following their first AUTO CAR T cell therapy infusion.
Detailed description
The purpose of this study is to monitor all patients exposed to an AUTO CAR T cell therapy, for up to 15 years following their first AUTO CAR T cell therapy infusion to assess the risk of delayed treatment-related SAEs, adverse events of special interest (AESIs), monitor for emergence of replication competent retrovirus (RCR) or replication competent lentivirus (RCL), monitor for the emergence of a new malignancy associated with insertional mutagenesis (insertion site analysis), assess CAR transgene persistence and assess long-term efficacy. Monitoring of such long-term effects of AUTO CAR T cell therapy will help to further define the risk-benefit profile of these new CAR T cell therapies.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUTO CAR T cell therapy | Experimental | Biological: AUTO CAR T cell therapyPatients who received previous treatment with AUTO CAR T Cell Therapy |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have received an AUTO CAR T cell therapy on a clinical treatment study.
- Patients must have provided informed consent for long-term follow-up study prior to participation.
- Patients must be able to comply with the study requirements.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AUTO CAR T cell therapyNo study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion. | Biological | AUTO CAR T cell therapy |
Primary outcome
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy
Time frame: For up to 15 years
Monitoring of all SAEs / AESIs, including any new malignancy or new diagnosis of neurologic disorders, or other hematologic disorder, related to AUTO CAR T cell therapy. Monitoring of all adverse events of special interest related to AUTO CAR T cell therapy infusion.
7 secondary outcomes
Overall Survival following first AUTO CAR T cell therapy infusion.
Time frame: For up to 15 years
Duration of supportive care
Time frame: For up to 15 years
Duration of response
Time frame: For up to 15 years
Progression-free survival
Time frame: For up to 15 years
Proportion of patients with detectable replication-competent retrovirus (RCR) or lentivirus (RCL) from first AUTO CAR T cell therapy infusion
Time frame: For up to 15 years
Proportion of patients with detectable vector copy number (VCN) in peripheral blood
Time frame: For up to 15 years
Testing for Insertional mutagenesis in case of a new malignancy
Time frame: For up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUTO CAR T cell therapy in people with Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy and Multiple Myeloma, run by Autolus Limited at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy (time frame: For up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.