A Phase 2 interventional study of AUTO CAR T cell therapy in Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy, Multiple Myeloma and DLBCL, sponsored by Autolus Limited. Enrolling by invitation at 9 sites in 3 countries. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Autolus Limited · Phase 2, Interventional, and Other
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.
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 500 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Autolus Limited is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who received previous treatment with AUTO CAR T Cell Therapy
Biological: AUTO CAR T cell therapy
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.
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.
Time frame: For up to 15 years
Overall Survival following first AUTO CAR T cell therapy infusion.
Overall Survival following first AUTO CAR T cell therapy infusion.
Time frame: 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.
Time frame: For up to 15 years
Duration of response
Clinical efficacy of AUTO CAR T cell therapy in patients enrolled prior to disease progression.
Time frame: For up to 15 years
Progression-free survival
Progression free survival following first AUTO CAR T cell therapy infusion.
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
Monitor for the absence of detectable RCR or RCL after the 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
Blood sample collection for VCN measurement to detect persistence of CAR transgene(s)
Time frame: 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.
Time frame: For up to 15 years
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2018 (actual). Primary completion is estimated for Jul 2043, 299 months after the start.
Of 93 industry-sponsored phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 77. This study's planned 299 months is above that.
Counting every sponsor, half of 505 studies reached it within 57 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Autolus Limited