AzTrials
AzTrials

Ovarian CancerPhase 2NCT05601752

ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)

A Phase 2 study testing Autologous genetically modified ADP-A2M4CD8 cells and Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab in people with Ovarian Cancer, run by USWM CT, LLC at 23 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Autologous genetically modified ADP-A2M4CD8 cells and Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
23 sitesin 5 countries
Study dates
26 Jun 2023to 24 Sep 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be assessed for eligibility prior to leukapheresis AND prior to lymphodepleting chemotherapy (unless otherwise noted) and must meet all specified criteria for study participation.
  • Subject (or legally authorized representative) has voluntarily agreed to participate by giving written informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and applicable local regulations.
  • Subject (or legally authorized representative) has agreed to abide by all protocol-required procedures including study related assessments and management by the treating institution for the duration of the study, including LTFU.
  • Subject is ≥ 18 and ≤ 75 years of age at the time the Pre Screening informed consent form (ICF) is signed.
  • Subject has histologically confirmed diagnosis of high-grade serous or high-grade endometrioid recurrent ovarian carcinoma, including primary peritoneal and fallopian tube carcinoma.
  • Subject has measurable disease according to RECIST v1.1 prior to lymphodepletion. Measurable disease is not required prior to leukapheresis.
Show all 24Show fewer
  • Subject has the following disease-specific prior therapy requirements:
  • The initial therapy must have included at least 3 cycles of a prior platinum and taxane based chemotherapy regimen for primary disease, possibly including intraperitoneal therapy, consolidation, or extended therapy (maintenance/consolidation).
  • Subjects may receive up to 4 prior regimens of combination or single agent systemic treatment for their disease, which may include investigational therapies unless discussed and agreed upon with the Sponsor or designee. Note: Neo-adjuvant/adjuvant treatment is considered as one line of treatment. Bridging therapy is permitted and is not considered as a line of treatment.
  • Subjects who have received only 1 line of platinum based therapy must have progressed between 93 and 183 days of completing platinum based therapy as a part of front line treatment of ovarian cancer. Subjects who have progressed within 92 days of completing platinum based therapy in front line treatment are excluded.
  • Subjects who have received 2 or more lines of platinum based therapy must have progressed during or within 183 days of completing the latest platinum based therapy for treatment of recurrent ovarian cancer. The number of days (platinum-free interval) should be calculated from the date of the last administered dose of platinum therapy to the date of documentation of progression.
  • Subjects with a known BRCA mutation (germ line or somatic) must have received a poly adenosine diphosphate-ribose polymerase (PARP).
  • Subjects must have received bevacizumab.
  • Positive for HLA-A*02:01, HLA-A*02:02, HLA-A*02:03, or HLA-A*02:06 allele as determined by Adaptimmune-designated central laboratory testing. HLA-A*02 alleles having the same protein sequence in the peptide binding domains (P group) will also be included. Other HLA-A*02 alleles may be eligible after adjudication with the Sponsor.
  • MAGE-A4 expression, defined as ≥ 30% of tumor cells that are ≥ 2+ by IHC, should be documented at the pre screening period based on either an archival specimen or a fresh biopsy. All samples must have been pathologically reviewed by an Adaptimmune-designated central laboratory confirming expression.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Subject has left ventricular ejection fraction (LVEF) of ≥ 50% or the institutional lower limit of normal range, whichever is lower.
  • Subject is fit for leukapheresis, and adequate venous access can be established for the cell collection.
  • Subjects of childbearing potential must have a negative urine or serum pregnancy test AND must agree to use a highly effective method of contraception starting at the first dose of chemotherapy and continue for at least 12 months or for 4 months after the gene-modified cells are no longer detected in the blood, or 6 months after the last dose of nivolumab, whichever is longer. Subjects of childbearing potential must also agree to refrain from egg donation, storage, or banking during these same time periods.
  • Subjects must have ≥ 90% room air oxygen saturation test at rest at Screening (within 7 days of leukapheresis) and at Baseline.
  • Subject must have adequate organ function as indicated by the laboratory values in the table below.
  • System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (without granulocyte colony stimulating factor [G-CSF] support) Platelets ≥ 100 × 109/L (without transfusion support within 5 days prior to leukapheresis and lymphodepletion) Hemoglobin (Hb) ≥ 90 g/L (without transfusion support within 5 days prior to leukapheresis and lymphodepletion) Coagulation Prothrombin time or international normalized ratio (INR) ≤ 1.5 × upper limit of normal (ULN), unless receiving therapeutic anticoagulation Partial thromboplastin time ≤ 1.5 × ULN, unless receiving therapeutic anticoagulation Renal Glomerular filtration rate (GFR) or creatinine clearance (CrCl) (estimated or calculated)1 ≥ 50 mL/min /1.73 m2 or ≥ 50 mL/min Hepatic Serum total bilirubin ≤ 1.5 × ULN (unless subject has documented Gilbert's Syndrome with direct bilirubin < 35% of total bilirubin) Exception: Subjects with liver metastasis ≤ 2.5 × ULN Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) ≤ 2.5 × ULN Albumin ≥ 3 g/dL (Without albumin deficit replacement within 7 days only prior to leukapheresis) Exception: Subjects with liver metastasis ≤ 5.0 × ULN
  • 1 Renal function (GFR or CrCl) will be estimated or measured according to standard practice at the treating institution. Renal function will be reassessed at Baseline using the same methodology.
  • Note: Laboratory values that are slightly out of the laboratory test parameters, if assessed as not clinically significant by the site study Investigator, may be acceptable after discussion and review by the Sponsor Study Physician. This applies to screening laboratory assessments and baseline laboratory assessments.

Who cannot join

  • Positive for HLA-A*02:05 in either allele as determined by Adaptimmune-designated central laboratory testing. HLA-A*02 alleles having the same protein sequence as HLA-A*02:05 in the peptide binding domains (P groups) will also be excluded. Other alleles may be exclusionary after adjudication with the Sponsor.
  • Subject has received or plans to receive the following therapy/treatment prior to to leukapheresis or lymphodepleting chemotherapy, unless stopped according to the washout requirements:
  • Cytotoxic chemotherapy Required Washout Prior to Leukapheresis 3 weeks Required Washout Prior to Lymphodepletion: 3 weeks
  • Small molecules/tyrosine kinase inhibitors (TKIs), such as dabrafenib, trametinib, vemurafenib, and cobimetinib Note: No washout period is required for compounds that do not cause bone marrow suppression/lymphopenia or for epidermal growth factor receptor and alkaline phosphatase/ ROS 1 inhibitors. Required Washout Prior to Leukapheresis 1 week Required Washout Prior to Lymphodepletion: 1 week
  • Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors, and biologics) other than anti-PD(L)1 Required Washout Prior to Leukapheresis 2 weeks Required Washout Prior to Lymphodepletion: 2 weeks
  • Anti-PD(L)1 Required Washout Prior to Leukapheresis 2 weeks Required Washout Prior to Lymphodepletion: 6 weeks
Show all 51Show fewer
  • Experimental anti-cancer vaccine Required Washout Prior to Leukapheresis: N/A Required Washout Prior to Lymphodepletion: Eight weeks in the absence of tumor response.
  • The subject should be excluded if their disease is responding to an experimental vaccine given within 6 months.
  • Gene therapy using an integrating vector Subjects who have received a gene therapy using any DNA-integrating vector other than a lentivirus (retrovirus, Adeno-associated Virus (AAV), etc.) are excluded from this study. Use of previous gene therapy using a lentiviral vector is permitted. If transduced T-cells represent < 1% of PBMCs (< 1500 copies of vectors/μg of PBMC DNA) at the time of screening. Eligibility testing must be done by Adaptimmune's designated Contract Research Organization (CRO). Required Washout Prior to Lymphodepletion: N/A
  • Corticosteroids or any other immunosuppressive therapy Note: Use of topical or inhaled steroids is not an exclusion. See Section 6.5.1 for exceptions.
  • Required Washout Prior to Leukapheresis: 2 weeks Required Washout Prior to Lymphodepletion 2 weeks
  • Anti-MAGE-A4 therapy Note: Fresh screening biopsy post-anti-MAGE-A4 therapy must be obtained to confirm MAGE-A4 positivity by IHC. Required Washout Prior to Leukapheresis: 2 weeks Required Washout Prior to Lymphodepletion: 2 weeks
  • Investigational treatment Required Washout Prior to Leukapheresis 2 weeks or 5 half-lives, whichever is shorter Required Washout Prior to Lymphodepletion: 2 weeks or 5 half-lives, whichever is shorter.
  • Radiation to vital organs (e.g., liver, kidney) Required Washout Prior to Leukapheresis: N/A Required Washout Prior to Lymphodepletion: 4 weeks
  • Radiation to the pelvis Required Washout Prior to Leukapheresis: 4 weeks Required Washout Prior to Lymphodepletion: 4 weeks
  • Whole brain radiotherapy (WBRT) or brain stereotactic radiosurgery (SRS) Required Washout Prior to Leukapheresis N/A Required Washout Prior to Lymphodepletion: 2 weeks
  • Radiotherapy to the target lesions Required Washout Prior to Leukapheresis: N/A Required Washout Prior to Lymphodepletion: 3 months prior to lymphodepleting chemotherapy or a target lesion with progression post radiotherapy (Note: There is no washout period for palliative radiation to non-target organs.)
  • PARP inhibitor Required Washout Prior to Leukapheresis: 1 week Required Washout Prior to Lymphodepletion: 1 week
  • Antibody drug conjugates (such as mirvetuximab) Required Washout Prior to Leukapheresis: 3 weeks Required Washout Prior to Lymphodepletion: 3 weeks Note: Duration of any other anti-cancer therapies must be discussed and agreed upon with the Sponsor Study Physician
  • Toxicity from previous anti-cancer therapy that has not recovered to Grade ≤ 1 or baseline prior to enrollment (except for nonclinically significant toxicities, e.g., alopecia and vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g., peripheral neuropathy) can be enrolled.
  • Subject has a history of allergic reactions attributed to compounds of similar chemical or biological composition to fludarabine, cyclophosphamide, or other agents used in the study.
  • Subject has an active autoimmune or immune-mediated disease that has not yet been resolved. Subjects with immune-mediated AEs secondary to treatment with immunotherapy that resolve to Grade ≤ 1 off steroids are permitted. Subjects with hypothyroidism, type I diabetes, adrenal insufficiency, or pituitary insufficiency that are stable on replacement therapy are eligible. Subjects with disorders such as asthma, vitiligo, psoriasis, or atopic dermatitis that are well controlled without requiring systemic immunosuppression are also eligible. Other stable immune conditions that do not require prednisone > 20 mg/day (or its equivalent for other corticosteroid agents) may be acceptable with the agreement of the Sponsor.
  • Subject had major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical-related toxicities. Surgical-related toxicities that are not clinically significant per Investigator assessment may be acceptable after discussion and agreement with the Study Physician.
  • Leptomeningeal disease, carcinomatous meningitis, or symptomatic central nervous system (CNS) metastases. Subjects with prior history of symptomatic CNS metastases must have received treatment (i.e., SRS, WBRT, or surgery) and be neurologically stable for at least 1 month, not requiring anti-seizure medications, or off steroids for at least 14 days prior to leukapheresis and lymphodepletion. Subjects who have asymptomatic CNS metastases without associated edema, shift, or requirement for steroids or anti-seizure medications are eligible. If such a subject receives SRS or WBRT, a minimum period of 2 weeks needs to lapse between the therapy and lymphodepletion. Prophylactic anti-seizure medication is allowed.
  • Subject has any other prior malignancy that is not considered by the Investigator to be in complete remission. Resectable squamous or basal cell carcinoma of the skin is acceptable. Prior malignancies that have been surgically resected and show no evidence of disease are acceptable.
  • Clinically significant cardiovascular disease including, but not limited to, any of the following:
  • Electrocardiogram (ECG) showing clinically significant abnormality at Screening
  • Uncontrolled clinically significant arrhythmias
  • Known family history or congenital history of prolonged QT syndrome or history of torsade de pointes
  • Uncontrolled hypertension despite optimal medical therapy
  • Acute coronary syndrome (angina or myocardial infarction) in the last 6 months
  • Clinically significant cardiac disease defined by congestive heart failure New York Heart Association Class 3 and 4
  • History of stroke, CNS bleeding, transient ischemic attack, or reversible ischemic neurologic deficit within last 6 months
  • Uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active systemic infection, or localized infection which may become systemic due to leukapheresis procedure, e.g., catheter insertion will be excluded. Subjects with urinary tract infections will be included only following treatment with antibiotics.(For SARS-CoV 2 [COVID-19] infection, see Section 10.4.4.1)
  • Clinically significant pulmonary disease with any 1 pulmonary function parameter < 60% predicted (forced expiratory volume first forced breath [FEV1], total lung capacity [TLC], or diffusing capacity of lungs for carbon monoxide [DLCO]; note: for patients with anemia, corrected DLCO could be used) assessed prior to leukapheresis and within 2 months of the start of lymphodepleting chemotherapy
  • Requirement for oxygen support (due to cardiac or pulmonary disease)
  • Interstitial lung disease (pneumonitis) or history of pneumonectomy or chronic obstructive pulmonary disease with ≥ 1 exacerbation within 1 year prior to the Screening Visit that required treatment with systemic corticosteroids or resulted in hospitalization
  • Hospitalization for bowel obstruction in last 2 months
  • Hematosis or significant organ bleeding in last 2 months
  • Ascites or pleural effusion which requires repeated (2 within 4 weeks) paracentesis or thoracentesis within last 2 months
  • Cardiac or pericardial tumor involvement (prior to lymphodepletion)
  • Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or human T cell leukemia virus (HTLV) as defined below. Re-screening for infectious disease markers is not required at baseline (prior to lymphodepletion) unless > 6 months has elapsed.
  • Positive serology for HIV
  • Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Subjects who are hepatitis B surface antigen negative but are hepatitis B core antibody-positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation. Prophylaxis should be initiated prior to lymphodepleting therapy and continued for 6 months.
  • Active hepatitis C infection as demonstrated by hepatitis C ribonucleic acid (RNA) test. Subjects who are HCV antibody-positive will be screened for HCV RNA by any reverse transcription-polymerase chain reaction (RT PCR) or branched DNA (bDNA) assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.
  • Positive serology for HTLV 1 or 2
  • Subject is pregnant or breastfeeding.
  • Subjects who have illicit drug or alcohol dependency within the past year.
  • In the opinion of the Investigator, subject will be unlikely to fully comply with protocol requirements.
  • Intolerance to nivolumab includes severe allergic reaction to nivolumab or any components (active or inactive) of nivolumab.

Trial locations and contacts

23 sites in 5 countries.

23 sites in 5 countries

United States9 sites

  • Augusta University

    Augusta, Georgia, 30912

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Rutgers Cancer Institute of NJ

    New Brunswick, New Jersey, 08901

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Honor Health

    Scottsdale, Arizona, 85258

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

Other trials in United States

Spain7 sites

  • Vall d'Hebron Unversity Hospital

    Barcelona, 08035

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Oncologico Clara Campal

    Madrid, 28050

  • Hospotal Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

France4 sites

  • Centre Leon-Berard

    Lyon, 69008

  • Institut de Cancerologie des Hospices Civils de Lyon

    Pierre-Bénite, Lyon, 69310

  • Institut de Cancerologie de Strasbourg

    Strasbourg, 67200

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

United Kingdom2 sites

  • University College of London Hospital

    London, NW1 2PG

  • The Christie Hospital

    Manchester, M20 4GJ

Other trials in United Kingdom

Canada1 site

  • University Health Network (Princess Margaret Cancer Center)

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase 2, Open-Label, Randomized, Non-Comparative Clinical Trial of ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in Subjects With Recurrent Ovarian Cancers

This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4.

Conditions
Ovarian Cancer
Being tested
Autologous genetically modified ADP-A2M4CD8 cells, Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous genetically modified ADP-A2M4CD8 cellsGenetic

    Infusion of autologous genetically modified ADP-A2M4CD8 cells on Day 1

  • Autologous genetically modified ADP-A2M4CD8 cells in combination with NivolumabCombination product

    Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 followed by nivolumab 480 mg IV at Week 4 and then every four weeks

Study groups in NCT05601752
Study groupRoleWhat they receive
Autologous genetically modified ADP-A2M4CD8 cellsExperimentalNot described
Receives: Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Autologous genetically modified ADP-A2M4CD8 cells in combination with NivolumabExperimentalNot described
Receives: Combination Product: Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer

    Overall Response (OR) is defined as incidence of (confirmed) complete responses or partial responses as assessed by RECIST v1.1 by IRAC from T-cell infusion until documented disease progression

    Measured: 3.6 years

Secondary outcomes (12)

  1. To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with nivolumab

    Determination of incidence of adverse events and incidence, severity, and duration of AESIs

    Measured: 3.6 years

  2. To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with nivolumab.

    Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis.

    Measured: 15 years

  3. Durable Response (DR)

    DR per RECIST v1.1 by IRAC and Investigator radiological assessment, defined as a confirmed OR (CR or PR) lasting continuously for 6 months and starting any time within 12 months of T-cell infusion

    Measured: 3.6 years

  4. Time to response (TTR)

    TTR per RECIST v1.1 by IRAC and Investigator radiological assessment, defined as the duration between the date of T-cell infusion and the initial date of the confirmed response.

    Measured: 3.6 years

  5. Duration of Response (DOR)

    DoR per RECIST v1.1 by IRAC and Investigator radiological assessment, defined as the duration from the initial date of the confirmed response to the earliest date of PD or death due to any cause.

    Measured: 3.6 years

  6. Progression Free Survival (PFS)

    PFS per RECIST v1.1 by IRAC and Investigator radiological assessment, defined as the interval between the date of T-cell infusion and the earliest date of disease progression or death due to any cause.

    Measured: 3.6 years

  7. Overall Response (OR)

    OR is defined as incidence of (confirmed) complete responses or partial responses as assessed by RECIST v1.1 by Investigator radiological assessment from T-cell infusion until documented disease progression

    Measured: 3.6 years

  8. Overall Survival (OS)

    OS, defined as the duration between the date of T-cell infusion and the date of death due to any cause.

    Measured: 15 years

  9. Levels of serum CA125

    Levels of serum CA125 (u/ml) for all patients

    Measured: 3.6 years

  10. Levels of serum CA125

    Changes of serum CA125 (u/ml) from baseline for all patients

    Measured: 3.6 years

  11. To characterize the surrogates of treatment effect

    Peak expansion (DNA copies/μg) (i.e., maximum persistence) by responder status and overall (all patients)

    Measured: 3.6 years

  12. To characterize the surrogates of treatment effect

    Time to peak expansion (in days since T-cell infusion) by responder status and overall (all patients)

    Measured: 3.6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2022
  2. Study start26 Jun 2023
  3. Primary completion30 Sep 2025
  4. Study completion24 Sep 2026

Why it stopped: Enrollment was halted following withdrawal of the U.S. IND. Previously enrolled participants completed treatment and follow-up, after which the study was closed.

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05601752
Sponsor's protocol ID
ADP-0055-003/GOG-3084
Status last verified
Oct 2026
First submitted
26 Oct 2022
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous genetically modified ADP-A2M4CD8 cells and Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab in people with Ovarian Cancer, run by USWM CT, LLC at 23 sites in 5 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 24 inclusion and 51 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Spain, France, United Kingdom, Canada. 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?

The study was stopped early (reason given: Enrollment was halted following withdrawal of the U.S. IND. Previously enrolled participants completed treatment and follow-up, after which the study was closed.). Results are not available in the source record.

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?

To evaluate the anti-tumor activity of genetically modified autologous T-cells (ADP-A2M4CD8) as monotherapy and in combination with nivolumab in HLA-A*02 positive subjects with MAGE-A4 positive recurrent ovarian cancer (time frame: 3.6 years). 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 NCT05601752.

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 19 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in