Breast CancerPhase 1NCT07553390
Phase 1b Study Of TRICK-NK In Combination With T-Dxd In Treatment-Refractory Breast Cancers
A Phase 1 study testing TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells, Trastuzumab deruxtecan (T-DXd) and Rimiducid in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of TGFBR-2 KO CD70 CAR NK (TRICK-NK) in combination with 2 doses of T-Dxd that can be given to participants who have advanced breast cancer. The safety of TRICK-NK will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells, Trastuzumab deruxtecan (T-DXd) and Rimiducid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Mar 2038
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Patients must have histologically confirmed breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of TRICK-NK cells in patients <18 years of age, children are excluded from this study.
- For patients with triple negative subtype (TNBC, ER<1%, PR 1%, HER2 negative per ASCO/ CAP 2018 guideline), must have received at least one dose of Sacituzumab govitecan or anti-TROP2 antibody drug conjugate (ADC)
- Patients must be at least 2 weeks from last cytotoxic chemotherapy, tyrosine kinase inhibitors or other targeted therapies at the time of administration of lymphodepleting chemotherapy.
- Patients must be at least 3 months from any cell therapy for malignancy (this is not a criteria for repeated treatments).
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- Localized radiotherapy to 1 or more disease sites is allowed prior to the lymphodepleting chemotherapy, if there are additional measurable non-irradiated disease sites.
- Eastern Cooperative Oncology Group performance status 0 or 1 (Performance level as measured by Karnofsky for patients > 16 years of age, see Appendix A).
- Adequate organ function at screening, as defined by the following:
- Renal: Estimated glomerular filtration rate (Chronic Kidney Disease Epidemiology Collaboration equation) ≥50 ml/min/1.73 m2
- Hepatic: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if documented liver metastases, total bilirubin ≤ 1.5 mg/dL or ≤ 3.0 mg/dL for patients with Gilbert's Syndrome. No history of liver cirrhosis.
- Cardiac: Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan, and no symptomatic cardiac disease or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication) Pulmonary: No clinically significant pleural effusion (per principal investigator [PI] judgement), and baseline oxygen saturation ≥ 92% on room air. Subjects with active interstitial lung disease (ILD)/pneumonitis requiring treatment with systemic steroids will be excluded.
- Hematological: absolute neutrophil count (ANC) ≥ 1000/mm3, platelet count ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL. Coagulation: International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN. Patients on therapeutic doses of anticoagulation medication must have INR and/or aPTT ≤ the upper limit of the therapeutic range for intended use.
- Able to provide written informed consent.
- Weight ≥40 kg (due to safety of NK-cell).
- A female patient is eligible to participate if at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 OR
- A WOCBP who agrees to follow the contraceptive guidelines in Appendix 5 during the study treatment period and for 6 months post-TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion.
- WOCBP must have a negative urine pregnancy test within 72 hours prior to the start of lymphodepleting chemotherapy. If a WOCBP has a urine pregnancy test that cannot be confirmed as negative, a serum (beta-human chorionic gonadotropin [β-hCG]) pregnancy test will be required.
- The effects of TROP2 CAR/IL-15 TGFBR2 KO NK cells on the developing human fetus are unknown. Radiation therapy is absolutely contraindicated in pregnant women. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Male patients treated or enrolled on this protocol must agree to follow the contraceptive guidelines in Appendix 5 prior to study entry and for the duration of study participation and for 6 months post-TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion. Male patients who father a child or suspect that they have fathered a child must immediately notify their doctor.
- Willing to undergo mandatory blood collections and biopsies as required by the study.
- Willing to sign consent for long-term follow-up on protocol PA17-0483.
- Willing to stay within a 2-hour drive (approximately 100-mile radius) of the study site during the first 4 weeks after the TROP2 CAR/IL-15 TGFBR2 KO NK cell infusion.
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Presence of clinically significant ongoing Grade ≥ 2 toxicity unequivocally associated with the previous anticancer treatment, as determined by the PI. Toxicities related to prior surgery, radiation, prior systemic immune checkpoint inhibitors and chemotherapy should be resolved to Grade 1 or below prior to lymphodepletion.
- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note: Patients with simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
- Known active hepatitis B or C.
- Known human immunodeficiency virus (HIV).
- Presence of active neurological disorder(s).
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- Active autoimmune disease within 12 months of enrollment (excluding low-grade psoriasis or well-controlled autoimmune thyroid disease).
- Amyloidosis or POEMS syndrome.
- Symptomatic or uncontrolled central nervous system involvement or signs of cord compression. In the case radiation therapy is indicated, the washout must be at least 14 days.
- Patients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, adequately treated (without recurrence post resection or post radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin, or active non-life-threatening second malignancy that would not, in the investigator's opinion, potentially interfere with the patient's ability to participate and/or complete this trial. Examples include but are not limited to urothelial cancer Grade Ta or T1 and adenocarcinoma of the prostate treated by active surveillance.
- Presence of any other serious medical condition that may endanger the patient at investigator's discretion, including but not limited to:
- New York Heart Association Class III or IV heart failure
- Myocardial infarction or stroke ≤ 26 weeks prior to CAR NK cell infusion
- Unstable angina within ≤ 13 weeks prior to CAR NK cell infusion unless the underlying disease has been corrected by procedural intervention (e.g., stent, bypass)
- Severe aortic stenosis
- Uncontrolled arrhythmia. PI approval is required for patients with arrhythmia who may be included as an exception.
- Congenital long QT syndrome. PI approval is required.
- Documentation, during the screening process, of a QTc > 470 milliseconds by Fredericia criteria (QTcF) based on the average of 3 electrocardiograms (ECGs) taken approximately 1 minute apart and all within 10 minutes of each other. The patient should be reclining for 5 minutes prior to ECGs. Local readings may be used for this exclusion criterion.
- Major surgery < 4 weeks prior to first dose of lymphodepleting chemotherapy.
- Concomitant use of other investigational agents.
- Concomitant use of other anticancer agents.
- Patients receiving systemic steroid therapy at time of enrollment, with an exception for topical, ocular, intranasal, and inhaled corticosteroids, or systemic corticosteroids at an equivalent dose ≤ 10 mg of prednisone daily (physiological substitutive doses are allowed).
- Received anti-thymocyte globulin within 14 days or alemtuzumab within 28 days of enrollment.
- Patients receiving immunosuppressive therapy.
- Pregnant or breastfeeding.
- Has received a live vaccine within 6 weeks prior to CAR NK cell infusion. Examples of live vaccines include but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza and COVID-19 vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Bora Lim, MD, 713-745-0689, blim@mdanderson.org
Bora Lim, MD
About this study
Official title: Phase 1b Study Of Allogeneic CAR TROP2/IL15 Transduced TGFBR2 KO CB NK-Cells (TRICK-NK) In Combination With Trastuzumab Deruxtecan (T-Dxd) In Treatment-Refractory Breast Cancers
The goal of this clinical research study is to find the highest tolerable dose of TGFBR-2 KO CD70 CAR NK (TRICK-NK) in combination with 2 doses of T-Dxd that can be given to participants who have advanced breast cancer. The safety of TRICK-NK will also be studied.
The goal of Part 1 (dose escalation) of this clinical research study is to find the highest tolerable dose of TRICK-NK (in combination with T-Dxd) that can be given to participants who have advanced breast cancer.
Read more
The goal of Part 2 (dose expansion) of this clinical research study is to learn if the dose of TRICK-NK found in Part 1 can help to control the disease.
The optional schedule optimization phase will test a shorter interval between the NK cell infusion and the first dose of T-Dxd.
Read the detailed description
Primary Objective:
To determine the safety, tolerability, maximum tolerated dose (MTD) and administration schedule, and optimal cell dose (OCD) and schedule of CAR.TROP2/IL15-transduced / TGFBR2KO CB-NK cells [TRICK-NK - TROP2-targeted, Reprogrammed with IL-15, CBderived, Knockout (TGFBR2) NK] + T-Dxd, in T-Dxd eligible HER2 positive and HER2 low advanced breast cancers.
Secondary Objectives:
To determine the antitumor activity of TRICK-NK + T-Dxd combination
The intent of offering this treatment is to provide a possible therapeutic benefit and thus, the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.
- Conditions
- Breast Cancer
- Being tested
- TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells, Trastuzumab deruxtecan (T-DXd), Rimiducid
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cellsDrug
Given by IV
Trastuzumab deruxtecan (T-DXd)Drug
Also called Enhertu
Given by IV
RimiducidDrug
Also called AP1903
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase: Treatment with TRICK-NK + T-Dxd (21 Days Interval) | Experimental | This phase will be conducted with a maximum of 21 participants to examine three escalating cell dose levels and one de-escalating cell dose level (level -1) with T-Dxd (21 days +/-3 days interval between cell infusion and each dose of T-Dxd treatment), to determine the safety and select the RP2D. Receives: Drug: TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells; Drug: Trastuzumab deruxtecan (T-DXd); Drug: Rimiducid |
| Dose Expansion Phase Cohort A and B: Treatment with TRICK-NK + T-Dxd (21 Days Interval) | Experimental | Investigators will enroll two cohorts of participants with up to 15 participants within each cohort to the RP2D to further evaluate the safety and preliminary efficacy. Receives: Drug: TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells; Drug: Trastuzumab deruxtecan (T-DXd); Drug: Rimiducid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Mar 2036 (estimated)
- Study completion30 Mar 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bora Lim, MD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553390
- Sponsor's protocol ID
- 2026-0140
- Other IDs
- NCI-2026-03278
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study Of Allogeneic CAR TROP2/IL15 Transduced TGFBR2 KO CB NK-Cells (TRICK-NK) In Combination With Trastuzumab Deruxtecan (T-Dxd) In Treatment-Refractory Breast Cancers
- ClinicalTrials.gov ID
- NCT07553390
- Acronym / sponsor ID
- 2026-0140
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2036 (estimated)
- Study completion
- 30 Mar 2038 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to find the highest tolerable dose of TGFBR-2 KO CD70 CAR NK (TRICK-NK) in combination with 2 doses of T-Dxd that can be given to participants who have advanced breast cancer. The safety of TRICK-NK will also be studied.
The goal of Part 1 (dose escalation) of this clinical research study is to find the highest tolerable dose of TRICK-NK (in combination with T-Dxd) that can be given to participants who have advanced breast cancer.
The goal of Part 2 (dose expansion) of this clinical research study is to learn if the dose of TRICK-NK found in Part 1 can help to control the disease.
The optional schedule optimization phase will test a shorter interval between the NK cell infusion and the first dose of T-Dxd.
Detailed description
Primary Objective:
To determine the safety, tolerability, maximum tolerated dose (MTD) and administration schedule, and optimal cell dose (OCD) and schedule of CAR.TROP2/IL15-transduced / TGFBR2KO CB-NK cells [TRICK-NK - TROP2-targeted, Reprogrammed with IL-15, CBderived, Knockout (TGFBR2) NK] + T-Dxd, in T-Dxd eligible HER2 positive and HER2 low advanced breast cancers.
Secondary Objectives:
To determine the antitumor activity of TRICK-NK + T-Dxd combination
The intent of offering this treatment is to provide a possible therapeutic benefit and thus, the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase: Treatment with TRICK-NK + T-Dxd (21 Days Interval) | Experimental | Drug: TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells, Drug: Trastuzumab deruxtecan (T-DXd), Drug: RimiducidThis phase will be conducted with a maximum of 21 participants to examine three escalating cell dose levels and one de-escalating cell dose level (level -1) with T-Dxd (21 days +/-3 days interval between cell infusion and each dose of T-Dxd treatment), to determine the safety and select the RP2D. |
| Dose Expansion Phase Cohort A and B: Treatment with TRICK-NK + T-Dxd (21 Days Interval) | Experimental | Drug: TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells, Drug: Trastuzumab deruxtecan (T-DXd), Drug: RimiducidInvestigators will enroll two cohorts of participants with up to 15 participants within each cohort to the RP2D to further evaluate the safety and preliminary efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Patients must have histologically confirmed breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for nonnodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of TRICK-NK cells in patients <18 years of age, children are excluded from this study.
- For patients with triple negative subtype (TNBC, ER<1%, PR 1%, HER2 negative per ASCO/ CAP 2018 guideline), must have received at least one dose of Sacituzumab govitecan or anti-TROP2 antibody drug conjugate (ADC)
- Patients must be at least 2 weeks from last cytotoxic chemotherapy, tyrosine kinase inhibitors or other targeted therapies at the time of administration of lymphodepleting chemotherapy.
Key exclusion criteria (26 listed)
- Presence of clinically significant ongoing Grade ≥ 2 toxicity unequivocally associated with the previous anticancer treatment, as determined by the PI. Toxicities related to prior surgery, radiation, prior systemic immune checkpoint inhibitors and chemotherapy should be resolved to Grade 1 or below prior to lymphodepletion.
- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management or not responding to appropriate therapy. Note: Patients with simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
- Known active hepatitis B or C.
- Known human immunodeficiency virus (HIV).
- Presence of active neurological disorder(s).
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 |
|---|---|---|
| TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cellsGiven by IV | Drug | Dose Escalation Phase: Treatment with TRICK-NK + T-Dxd (21 Days Interval), Dose Expansion Phase Cohort A and B: Treatment with TRICK-NK + T-Dxd (21 Days Interval) |
| Trastuzumab deruxtecan (T-DXd)Also: EnhertuGiven by IV | Drug | Dose Escalation Phase: Treatment with TRICK-NK + T-Dxd (21 Days Interval), Dose Expansion Phase Cohort A and B: Treatment with TRICK-NK + T-Dxd (21 Days Interval) |
| RimiducidAlso: AP1903Given by IV | Drug | Dose Escalation Phase: Treatment with TRICK-NK + T-Dxd (21 Days Interval), Dose Expansion Phase Cohort A and B: Treatment with TRICK-NK + T-Dxd (21 Days Interval) |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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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.
Bora Lim, MD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TGFBR2 KO iC9/TROP2.CAR/IL-15 NK cells, Trastuzumab deruxtecan (T-DXd) and Rimiducid in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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 29 inclusion and 26 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: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bora Lim, MD ((713) 745-0689, blim@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026.