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AUTO CAR T cell therapy

Phase 2

Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy | Monoclonal antibody | Oncology |Autolus Therapeutics plc|Last Updated: Aug 7, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Clinical trial landscape

AUTO CAR T cell therapy · 1 trial · 5 indications

Phase 2 1
NCT03628612Long-term Follow-up of Patients Treated With Genetically Modified Autologous T CellsPatients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell Therapy
ENROLLING BY_INVITATION500 Analytics
PHASE2ENROLLING BY_INVITATION
Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells
Patients Followed for up to 15 Years Following Their First Dose of AUTO CAR T Cell TherapyUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Serious Adverse Events (SAE), new malignancies & adverse events of special interest (AESI) related to AUTO CAR T cell therapy
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.

Secondary Endpoints

Overall Survival following first AUTO CAR T cell therapy infusion.
Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
Duration of supportive care
Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
Duration of response
Month 3, Month 6, Month 9, Month 12 during Year 1 following AUTO CAR T cell therapy infusion, then every 6 months up to Year 5, then yearly up to Year 15
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
AUTO CAR T cell therapyEXPERIMENTALPatients who received previous treatment with AUTO CAR T Cell Therapy

Interventions

NameTypeDescription
AUTO CAR T cell therapyBIOLOGICALNo 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.
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Eligibility Criteria

Age Range1 Year to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Patients must have received an AUTO CAR T cell therapy on a clinical treatment study. 2. Patients must have provided informed consent for long-term follow-up study prior to participation. 3. Patients must be able to comply with the study requirements. Exclusion Criteria: 1....

Countries:United StatesUnited Kingdom
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Frequently asked questions about AUTO CAR T cell therapy

What is AUTO CAR T cell therapy used for?

AUTO CAR T cell therapy is a genetically modified autologous T cell treatment being studied in oncology. It is used in a long-term follow-up study for patients with multiple myeloma, diffuse large B-cell lymphoma (DLBCL), acute lymphoblastic leukemia (ALL) in adults and children, and T cell lymphoma. The study follows patients for up to 15 years after their first dose.

Who makes AUTO CAR T cell therapy?

AUTO CAR T cell therapy is being developed by Autolus Therapeutics plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol AUTL. The company is conducting a Phase 2 clinical trial to evaluate the long-term safety and outcomes of this genetically modified cell therapy in patients with certain blood cancers.

What phase is AUTO CAR T cell therapy in?

AUTO CAR T cell therapy is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The current Phase 2 trial is a long-term follow-up study designed to monitor patients for up to 15 years after their first dose of the therapy.

What clinical trials is AUTO CAR T cell therapy in?

AUTO CAR T cell therapy is being studied in one clinical trial registered as NCT03628612, titled "Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells." This Phase 2 trial is enrolling by invitation and aims to enroll 500 participants across the United States and United Kingdom. The study is uncontrolled and not blinded.

How does AUTO CAR T cell therapy work?

AUTO CAR T cell therapy works by using genetically modified autologous T cells, which are a patient's own immune cells that have been engineered to recognize and attack cancer cells. This approach is designed to target and destroy malignant cells in conditions such as multiple myeloma, DLBCL, ALL, and T cell lymphoma.