TerminatedPhase 1/2

Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma

Stopped: Only Phase I of the study was conducted.

Spain, United Kingdom20 participantsStarted 2018-08-30

Plain-language summary

The purpose of this study is to test the safety and efficacy of AUTO4 a chimeric antigen receptor (CAR) T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive selected T-Non-Hodgkin Lymphoma (NHL).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female, aged ≥ 18 years.
. Willing and able to give written, informed consent to be screened for TRBC1 positive T-NHL and to enter the main study.
. Confirmed diagnosis of selected T-NHL, including:
. Peripheral T cell lymphoma not otherwise specified, or
. Angioimmunoblastic T cell lymphoma, or
. Anaplastic large cell lymphoma
. Confirmed TRBC1 positive tumour.
. Relapsed or refractory disease and have had ≥1 prior lines of therapy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Numbers of Patients With Grade 3 to 5 Toxicity Occurring Within 60 Days of AUTO4 Infusion.

Timeframe: 60 days of AUTO4 infusion

Frequency of Dose-limiting Toxicity (DLT) of AUTO4 Within 28 Days of AUTO4 Infusion.

Timeframe: 28 days of AUTO4 infusion

Trial details

NCT IDNCT03590574

SponsorAutolus Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-12

Results submitted2025-12-10

View on ClinicalTrials.gov More T Cell Non-Hodgkin Lymphoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female, aged ≥ 18 years.
. Willing and able to give written, informed consent to be screened for TRBC1 positive T-NHL and to enter the main study.
. Confirmed diagnosis of selected T-NHL, including:
. Peripheral T cell lymphoma not otherwise specified, or
. Angioimmunoblastic T cell lymphoma, or
. Anaplastic large cell lymphoma
. Confirmed TRBC1 positive tumour.
. Relapsed or refractory disease and have had ≥1 prior lines of therapy.

Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria