T Cell Non-Hodgkin LymphomaPhase 1/2NCT03590574
Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma
A Phase 1/2 study testing AUTO4 in people with T Cell Non-Hodgkin Lymphoma and Peripheral T-Cell Lymphoma, Not Otherwise Specified, run by Autolus Limited at 5 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T Cell Non-Hodgkin Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma
- What is being tested?
- AUTO4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Aug 2018to 12 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Confirmed TRBC1 positive tumour.
- Relapsed or refractory disease and have had ≥1 prior lines of therapy.
- Positron emission tomography (PET)-positive measurable disease per Lugano classification.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Adequate bone marrow function without the requirement for ongoing blood products.
- Adequate renal, hepatic, pulmonary, and cardiac function.
- For females of childbearing potential (defined as < 2 years after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to pre-conditioning and confirmed before receiving the first dose of study treatment. For females who are not postmenopausal (< 24 months of amenorrhea) or who are not surgically sterile (absence of ovaries and/or uterus), a highly effective method of contraception together with a barrier method must be used from the start of the pre-conditioning stage and for at least 12 months after the last dose of AUTO4 (study treatment). They must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 12 months after receiving the last dose of study drug
- For males, it must be agreed that 2 acceptable methods of contraception are used.
- No contra-indications for leukapheresis, or the pre-conditioning regimen.
Who cannot join
- Patients meeting any of the following exclusion criteria must not be enrolled into the study:
- Patients with T cell leukaemia.
- Females who are pregnant or lactating.
- Prior treatment with investigational gene therapy or approved gene therapy or genetically engineered cell therapy product or allogeneic stem cell transplant.
- Known history or presence of clinically relevant central nervous system (CNS) pathology. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS.
- Current or history of CNS involvement by malignancy.
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- Clinically significant, uncontrolled heart disease.
- Patients with evidence of uncontrolled hypertension or with a history of hypertension crisis or hypertensive encephalopathy.
- Patients with a history (within 3 months) or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning.
- Patients with active gastrointestinal bleeding.
- Active infectious bacterial, viral disease or fungal disease (hepatitis B virus, hepatitis C virus, human immunodeficiency virus, human T cell lymphotropic virus or syphilis) requiring treatment.
- Active autoimmune disease requiring immunosuppression.
- History of other neoplasms unless disease free for at least 2 years (adequately treated carcinoma in situ, curatively treated non-melanoma skin cancer, breast or prostate cancer on hormonal therapy are allowed).
- Prior treatment with programmed cell death protein 1, programmed death ligand 1, or cytotoxic T lymphocyte-associated protein 4 targeted therapy, or tumour necrosis factor (TNF) receptor superfamily agonists including cluster of differentiation (CD)134 (OX40), CD27, CD137 (41BB), and CD357 (glucocorticoid induced TNF receptor family related protein) within 6 weeks prior to AUTO4 infusion.
- Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy.
- Use of rituximab (or rituximab biosimilar) within the last 6 months prior to AUTO4 infusion.
- Patients, who in the opinion of the Investigator, may not be able to understand or comply with the safety monitoring requirements of the study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom4 sites
Queen Elizabeth University Hospital
Glasgow
University College London Hospitals NHS Foundation Trust
London
Manchester Royal Infirmary Hospital
Manchester
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne
About this study
Official title: A Single Arm, Open Label, Multi-centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO4, a CAR T-cell Treatment Targeting TRBC1, in Patients With Relapsed or Refractory TRBC1 Positive Selected T Cell Non-Hodgkin Lymphoma
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).
Read the detailed description
The study will consist of 2 phases, a Phase I/dose escalation phase and a Phase II/expansion phase. Patients with relapsed or refractory TRBC1 positive selected T-NHL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis to harvest T cells, the starting material for the manufacture of the autologous CAR-T product AUTO4. Following preconditioning by a chemotherapeutic regimen, the patient will receive AUTO4 intravenously as a single dose following which they will then enter a 24-month follow-up period
- Conditions
- T Cell Non-Hodgkin Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma
- Being tested
- AUTO4
- Keywords
- T cell lymphoma, Relapsed T cell Non-Hodgkin Lymphoma, Refractory T cell Non-Hodgkin Lymphoma, AUTO4
- Medical subject headings
- Lymphoma, T-Cell, Immunoblastic Lymphadenopathy, Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUTO4Biological
AUTO4 (Ritux-QBEND/10-Ritux-CD8 sort-suicide gene generated as a marker/suicide gene for T cells [RQR8]/anti-T cell receptor beta constant [aTRBC]1 CAR T cells). Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with doses from 25 to 900 x 10^6 RQR8/anti-TRBC1 CAR T cells in Phase I. Following dose determination patients will be treated with the selected doses of RQR8/aTRBC1 CAR T cells (AUTO4) in Phase II.
| Study group | Role | What they receive |
|---|---|---|
| AUTO4 | Experimental | Relapsed or refractory T cell non-Hodgkin Lymphoma patients Receives: Biological: AUTO4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numbers of Patients With Grade 3 to 5 Toxicity Occurring Within 60 Days of AUTO4 Infusion.
To assess the safety and tolerability of AUTO4 administration. The incidence of Grade 3-5 toxicities occurring within 60 days of AUTO4 infusion.
Measured: 60 days of AUTO4 infusion
Frequency of Dose-limiting Toxicity (DLT) of AUTO4 Within 28 Days of AUTO4 Infusion.
To identify the recommended Phase II dose and maximum tolerated dose (MTD), if an MTD exists, of AUTO4 by monitoring the frequency of DLT of AUTO4 within 28 days of AUTO4 infusion.
Measured: 28 days of AUTO4 infusion
Secondary outcomes (11)
Frequency and Severity of All Adverse Events (AEs) and Serious Adverse Events (SAEs).
All AEs/SAEs were recorded from admission for pre-conditioning chemotherapy (Day -6 relative to AUTO4). Due to the long period between consent and AUTO4 treatment, any AEs/SAEs related to bridging chemotherapy not associated with study procedures did not require reporting as study AEs/SAEs. Any significant events were added to the patient's medical history. All AEs/SAEs related to study procedures (leukapheresis, bone marrow assessments) were reported.
Measured: 24 months post treatment
To Assess the Overall Safety and Tolerability of AUTO4.
Incidence and severity of opportunistic infections following AUTO4 infusion.
Measured: 24 months post treatment
Feasibility of Generating AUTO4: Number of Patients Whose Cells Achieve Successful AUTO4 Manufacture as a Proportion of the Number of Patients Undergoing Leukapheresis.
Feasibility of product generation was examined by assessing the number of AUTO4 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients enrolled).
Measured: Up to 8 weeks post leukapheresis
Determine the Complete Response (CR) Rate Following Treatment With AUTO4.
Participants achieving CR per Lugano criteria based on independent central radiology review.
The Lugano classification of response by 18F (Fluorine isotope 18)-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) positron emission tomography (PET)-computed tomography (CT):
- no uptake or no residual uptake (when used interim)
- slight uptake, but below blood pool (mediastinum)
- uptake above mediastinal, but below or equal to uptake in the liver
- uptake slightly to moderately higher than liver
- markedly increased uptake or any new lesion (on response evaluation) Non-progressive disease
- complete metabolic response - score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass
- partial metabolic response - score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size
- stable disease or no metabolic response - score of 4 or 5 with no obvious change in FDG uptake Progressive disease score 4 or 5 in any lesion
Measured: Up to 24 months
Evaluate Duration of Response (DOR) Following Treatment With AUTO4.
DOR was defined as the time from the first observed CR or partial response (PR) to documented disease progression or death due to any cause, for patients who were considered as responders.
Patients who received protocol specified anti-cancer treatment post AUTO4 infusion were ignored in the main analysis.
Patients who proceeded to stem cell transplantation (SCT) after AUTO4 infusion were censored at the time of SCT (including the conditioning regimen for SCT).
Patients who received new non-protocol anticancer therapies other than SCT were censored at the date of last adequate assessment prior to the new therapy.
Patients who experienced event after missing two or more scheduled disease assessments were censored at the date of last adequate assessment prior to the event.
Data for DOR were pooled for analysis because the number of patients was <5 for all of the groups and the intended model cannot be built with such a small sample size.
Measured: Up to 24 months
Evaluate Progression-free Survival (PFS) Following Treatment With AUTO4.
PFS was defined as the time from the first treatment of AUTO4 to documented disease progression/relapse or death due to any cause.
If a patient did not have relapse or death due to any reason prior to data cut-off, PFS was censored at the date of the last adequate assessment by default.
Patients who received protocol specified anti-cancer treatment post AUTO4 infusion were ignored in the main analysis.
Patients who proceeded to SCT after AUTO4 infusion were censored at the time of SCT (including the conditioning regimen for SCT).
Patients who received new non-protocol anticancer therapies other than SCT were censored as the date of last adequate assessment prior to the new therapy.
Patients who experienced event after missing two or more scheduled disease assessments were censored at the date of last adequate assessment prior to the event
Measured: Up to 24 months
Evaluate Overall Survival (OS) Following Treatment With AUTO4.
OS was defined as the time from the first treatment of AUTO4 to death due to any cause.
Patients who had not died prior to data cut-off or database finalization were censored at the last contact date.
Patients who received SCT after AUTO4 infusion were ignored in the main analysis.
Measured: Up to 24 months
Time to Response (PR and CR)
Time taken for participants achieving PR or CR per Lugano criteria based on independent central radiology review.
The Lugano classification of response by 18F FDG PET-CT:
- no uptake or no residual uptake (when used interim)
- slight uptake, but below blood pool (mediastinum)
- uptake above mediastinal, but below or equal to uptake in the liver
- uptake slightly to moderately higher than liver
- markedly increased uptake or any new lesion (on response evaluation)
Non-progressive disease:
- Complete metabolic response - score of 1, 2, or 3 in nodal or extranodal sites with or without a residual mass
- Partial metabolic response - score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size
Measured: 24 months post treatment
Evaluate Time to CR Following Treatment With AUTO4.
The time taken for participants achieving CR per Lugano criteria based on independent central radiology review.
The Lugano classification of response by 18F-2-fluoro-2-deoxy-D-glucose FDG PET-CT:
- no uptake or no residual uptake (when used interim)
- slight uptake, but below blood pool (mediastinum)
- uptake above mediastinal, but below or equal to uptake in the liver
- uptake slightly to moderately higher than liver
- markedly increased uptake or any new lesion (on response evaluation)
Non-progressive disease:
- Complete metabolic response - score of 1, 2, or 3 in nodal or extranodal sites with or without a residual mass
Measured: Up to 24 months
To Determine the Expansion and Persistence of AUTO4 Following Infusion.
RQR8/aTRBC1-CAR positive T cells as determined by polymerase chain reaction at a range of time points in the peripheral blood.
Measured: Up to 24 months
Duration of TRBC1 Positive T Cell Aplasia.
Enumeration of circulating T cell receptor beta constant 1 positive T cells assessed by flow cytometry at a range of time points in the peripheral blood.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start30 Aug 2018
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Why it stopped: Only Phase I of the study was conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T Cell Non-Hodgkin LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autolus Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590574
- Sponsor's protocol ID
- AUTO4-TL1
- Other IDs
- 2017-001965-26, 2017
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2018
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cwynarski K, Iacoboni G, Tholouli E, Menne T, Irvine DA, Balasubramaniam N, Wood L, Shang J, Xue E, Zhang Y, Basilico S, Neves M, Raymond M, Scott I, El-Kholy M, Jha R, Dainton-Smith H, Hussain R, Day W, Ferrari M, Thomas S, Lilova K, Brugger W, Marafioti T, Lao-Sirieix P, Maciocia P, Pule M. TRBC1-CAR T cell therapy in peripheral T cell lymphoma: a phase 1/2 trial. Nat Med. 2025 Jan;31(1):137-143. doi: 10.1038/s41591-024-03326-7. Epub 2024 Nov 11.
PubMed 39528665
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Multi-centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO4, a CAR T-cell Treatment Targeting TRBC1, in Patients With Relapsed or Refractory TRBC1 Positive Selected T Cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT03590574
- Acronym / sponsor ID
- AUTO4-TL1
- Conditions
- T Cell Non-Hodgkin Lymphoma, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Angioimmunoblastic T-cell Lymphoma, Anaplastic Large Cell Lymphoma
- Keywords
- T cell lymphoma, Relapsed T cell Non-Hodgkin Lymphoma, Refractory T cell Non-Hodgkin Lymphoma, AUTO4
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only Phase I of the study was conducted.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Autolus LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Posted 16 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study will consist of 2 phases, a Phase I/dose escalation phase and a Phase II/expansion phase. Patients with relapsed or refractory TRBC1 positive selected T-NHL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis to harvest T cells, the starting material for the manufacture of the autologous CAR-T product AUTO4. Following preconditioning by a chemotherapeutic regimen, the patient will receive AUTO4 intravenously as a single dose following which they will then enter a 24-month follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUTO4 | Experimental | Biological: AUTO4Relapsed or refractory T cell non-Hodgkin Lymphoma patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Confirmed TRBC1 positive tumour.
- Relapsed or refractory disease and have had ≥1 prior lines of therapy.
Key exclusion criteria (17 listed)
- Patients meeting any of the following exclusion criteria must not be enrolled into the study:
- Patients with T cell leukaemia.
- Females who are pregnant or lactating.
- Prior treatment with investigational gene therapy or approved gene therapy or genetically engineered cell therapy product or allogeneic stem cell transplant.
- Known history or presence of clinically relevant central nervous system (CNS) pathology. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS.
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 |
|---|---|---|
| AUTO4AUTO4 (Ritux-QBEND/10-Ritux-CD8 sort-suicide gene generated as a marker/suicide gene for T cells [RQR8]/anti-T cell receptor beta constant [aTRBC]1 CAR T cells). Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with doses from 25 to 900 x 10^6 RQR8/anti-TRBC1 CAR T cells in Phase I. Following dose determination patients will be treated with the selected doses of RQR8/aTRBC1 CAR T cells (AUTO4) in Phase II. | Biological | AUTO4 |
Primary outcome
The Numbers of Patients With Grade 3 to 5 Toxicity Occurring Within 60 Days of AUTO4 Infusion.
Time frame: 60 days of AUTO4 infusion
To assess the safety and tolerability of AUTO4 administration. The incidence of Grade 3-5 toxicities occurring within 60 days of AUTO4 infusion.
Frequency of Dose-limiting Toxicity (DLT) of AUTO4 Within 28 Days of AUTO4 Infusion.
Time frame: 28 days of AUTO4 infusion
To identify the recommended Phase II dose and maximum tolerated dose (MTD), if an MTD exists, of AUTO4 by monitoring the frequency of DLT of AUTO4 within 28 days of AUTO4 infusion.
11 secondary outcomes
Frequency and Severity of All Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time frame: 24 months post treatment
To Assess the Overall Safety and Tolerability of AUTO4.
Time frame: 24 months post treatment
Feasibility of Generating AUTO4: Number of Patients Whose Cells Achieve Successful AUTO4 Manufacture as a Proportion of the Number of Patients Undergoing Leukapheresis.
Time frame: Up to 8 weeks post leukapheresis
Determine the Complete Response (CR) Rate Following Treatment With AUTO4.
Time frame: Up to 24 months
Evaluate Duration of Response (DOR) Following Treatment With AUTO4.
Time frame: Up to 24 months
Evaluate Progression-free Survival (PFS) Following Treatment With AUTO4.
Time frame: Up to 24 months
Evaluate Overall Survival (OS) Following Treatment With AUTO4.
Time frame: Up to 24 months
Time to Response (PR and CR)
Time frame: 24 months post treatment
Evaluate Time to CR Following Treatment With AUTO4.
Time frame: Up to 24 months
To Determine the Expansion and Persistence of AUTO4 Following Infusion.
Time frame: Up to 24 months
Duration of TRBC1 Positive T Cell Aplasia.
Time frame: Up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39528665Cwynarski K, Iacoboni G, Tholouli E, Menne T, Irvine DA, Balasubramaniam N, Wood L, Shang J, Xue E, Zhang Y, Basilico S, Neves M, Raymond M, Scott I, El-Kholy M, Jha R, Dainton-Smith H, Hussain R, Day W, Ferrari M, Thomas S, Lilova K, Brugger W, Marafioti T, Lao-Sirieix P, Maciocia P, Pule M. TRBC1-CAR T cell therapy in peripheral T cell lymphoma: a phase 1/2 trial. Nat Med. 2025 Jan;31(1):137-143. doi: 10.1038/s41591-024-03326-7. Epub 2024 Nov 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AUTO4 in people with T Cell Non-Hodgkin Lymphoma and Peripheral T-Cell Lymphoma, Not Otherwise Specified, run by Autolus Limited at 5 sites in 2 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 15 inclusion and 17 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: stopped early, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 16 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Numbers of Patients With Grade 3 to 5 Toxicity Occurring Within 60 Days of AUTO4 Infusion. (time frame: 60 days of AUTO4 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590574, which also lists 1 linked publication.
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 16 Mar 2026.