Acute Myeloid Leukemia (AML)Phase 1/2NCT04284228
Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT
A Phase 1/2 study testing Infusion of NEXI-001 T Cells in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by NexImmune Inc. at 5 sites in United States.
Trial summary
This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-001 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia (AML) or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
- What is being tested?
- Infusion of NEXI-001 T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesUnited States
- Study dates
- 20 Feb 2020to Mar 2025
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General
- Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens
- Age ≥ 18 years old
- Expression of HLA-A*0201 as determined by high resolution sequence-based typing method (e.g. TruSight HLA v2 Sequence Panel)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have a confirmed diagnosis of AML (according to World Health Organization (WHO) classification) or MDS with evidence of MRD or morphological relapse after HLA-matched allogeneic HCT
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- MRD includes:
- Detection of blasts <5% in bone marrow
- Detection of a clonal abnormal blast population via multi-color flow cytometry
- Detection of known or new myeloid gene mutations
- Donor match at 10 of 10 loci for HLA-A, -B, -C, -DRB1 and DQB1, with each typed at high resolution by DNA-based methods.
- Patients who have had prior HLA-mismatched or haploidentical allogeneic HCT will not be eligible
- T-cell chimerism ≥ 50% to donor (by PCR analysis)
- Acceptable laboratory parameters as follows:
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN, except patients with Gilbert's syndrome, who may enroll if the conjugated bilirubin is within normal limits
- Creatinine < 1.5 mg/dL or a calculated or measured creatinine clearance (CL) ≥ 50 mL/min per standard calculation
- Recovery to Grade 1 or baseline of non-hematologic toxicities from prior treatments, excluding alopecia
- Female patients of childbearing potential must test negative for pregnancy at enrollment and during the study. Sexually active women of child-bearing potential, unless surgically sterile, must be willing to use a highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) such as implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs) or vasectomized partner
- Male patients with partners of childbearing potential must be either vasectomized or agree to use a condom in addition to having their partners use another method of contraception resulting in a highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) such as implants, injectables, combined oral contraceptives, or IUDs. Patients should not have sexual intercourse with females who are either pregnant or lactating without double-barrier contraception Is not pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the prescreening or screening visit through one year from administration of NEXI-001 cells
Who cannot join
- Active acute or chronic graft versus host disease (GvHD)
- Eligible patients will not be on any steroids ≥10 mg per day prednisone or equivalent or other immunosuppressants such as tacrolimus, cyclosporine, etc.
- Intermittent topical, inhaled or intranasal corticosteroids are allowed
- Have active or uncontrolled infections with positive cultures and/or requiring treatment with IV anti-infective agents
- History of clinically significant cardiovascular disease including but not limited to:
- Myocardial infarction or unstable angina within the 6 months prior to the initiation of study
Show all 29Show fewer
- Stroke or transient ischemic attack within 6 months prior to initiation of study
- Clinically significant cardiac arrhythmia
- Uncontrolled hypertension: systolic blood pressure (SBP) > 180 mmHg, diastolic blood pressure (DBP) > 100 mmHg
- Congestive heart failure (New York Heart Association [NYHA] class III-IV)
- Pericarditis or clinically significant pericardial effusion
- Myocarditis
- Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
- History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus erythematosus, etc.) resulting in end organ injury or requiring systemic immunosuppression / systemic disease modifying agents within the last 2 years prior to enrollment. Subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and subjects with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for the study
- Human immunodeficiency virus (HIV) seropositive; HIV testing within 2 years of enrollment
- Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV). Patients who are hepatitis B surface antigen (HBsAg) negative and HBV viral DNA negative are eligible
- Patients who had HBV but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible
- Patients who are seropositive because of HBV vaccine are eligible
- Seropositive for and with active viral infection with hepatitis C virus (HCV)
- Patients who had HCV but have received an antiviral treatment and show no detectable HCV viral DNA for 6 months are eligible
- Second primary invasive malignancy that has not been in remission for greater than 2 years. Exceptions that do not require a 2-year remission include: resected non-melanoma skin cancer; carcinoma in situ (cervix, bladder, breast, etc.) or squamous intraepithelial lesion on Pap smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ
- History of trauma or major surgery within 4 weeks prior to the study enrollment
- Any serious underlying medical or psychiatric condition that would impair the ability of the patient to receive or tolerate the planned treatment and follow up
- Known hypersensitivity to any component of NEXI-001 T cells, cyclophosphamide, fludarabine or tocilizumab
- Vaccination with any live virus vaccine is not permitted prior to the initiation of study treatment. Inactivated annual influenza vaccination is allowed.
- Dementia or altered mental status that would preclude understanding and rendering of informed consent
- History of seizures, aphasia, psychosis or other chronic clinically significant neurologic disorders
- Patients with remote history of seizures that are well controlled on anti-seizure medications and without any seizure episode for 6 months are eligible
- Any issue that in the opinion of the investigator, would contraindicate the patient's participation in the study or confound the results of the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The James Cancer Hospital and Solove Research Institute OSUCC
Columbus, Ohio, 43210
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, 10021
Advent Health Medical Group Blood & Marrow Transplant
Orlando, Florida, 32804
About this study
Official title: A Phase 1 / 2 Study to Evaluate the Safety, Tolerability and Initial Anti-Tumor Activity of Adoptively Transferred T Lymphocytes Targeting WT1, PRAME and Cyclin A1 AML or MDS Patients With Relapsed Disease After Matched Allogeneic HCT
This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-001 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have relapsed disease after an allogeneic hematopoietic cell transplant (HCT).
The study will enroll AML or MDS patients who have either Minimal Residual Disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic HCT. Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study. Eligible patients for this study must also have ≥ 50% T-cell chimerism from the original donor at the time study entry.
The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigator's discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-001 T cell product.
Read the detailed description
The NEXI-001 is an adoptive cellular therapy product which contains populations of antigen-specific CD8+ T cells. The antigen-specific CD8+ T cells in the NEXI-001 T cell product are derived from Peripheral Blood Mononuclear Cells (PBMC) obtained from the original stem cell donor. During the manufacturing process, these cells are primed and expanded ex vivo using nano-size artificial Antigen Presenting Cells (aAPC) loaded with five leukemia associated antigen peptides in combination with a proprietary T cell enrichment and expansion process.
The NEXI-001 T cell product is restricted to patients that are HLA-A2.01 allele positive for this study.
There are two parts to this study, a Safety Evaluation Phase and a Dose Expansion Phase. The Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-001 T cell product, and will consist of Dose Escalation at two dose levels - each with cohorts of three patients.
When all three patients at Dose Level 1 have dosed and cleared the DLT period, three additional patients will be enrolled at Dose Level 2. When three patients have cleared the DLT period at the highest dose level, that dose will be advanced to the Dose Expansion Phase. The Dose Expansion Phase will enroll up to 16 additional patients to further define the safety and evaluate the initial anti-tumor efficacy of the NEXI- 001 T cell product at the dose established from the Safety Evaluation Phase.
All patients will enter a Post-Treatment Follow-Up period after infusion of the NEXI- 001 T cell product. During this phase, all patients will be monitored for AEs and followed for anti-leukemia response until the end of study visit is complete (up to one year).
Additional assessments for safety, disease status, and other secondary and exploratory endpoints will also be monitored during the follow-up period.
All patients will be followed for overall survival (OS) from time of disease progression until the last visit of the last patient. During this time, patients will be followed via telephone or other electronic contact at 12 week intervals for monitoring of OS.
- Being tested
- Infusion of NEXI-001 T Cells
- Keywords
- AML, MDS, HCT
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of NEXI-001 T CellsBiological
Procedure: A single IV infusion of NEXI-001 T Cells at Day 1 after Lymphodepletion(LD) Therapy.
At dose Level 1: 1.0 x 108 total viable T cells At dose Level 2: 2.0 x 108 total viable T cells
Procedure: Lymphodepletion: IV administration of fludarabine 30 mg/2 and cyclophosphamide 300 mg/m2 for 3 days.
lymphodepletion (LD) Therapy: Subjects will received bridging therapy agents during lymphodepletion for 3 consecutive days prior to receiving the NEXI-001 product
Drug: Fludarabine
Fludarabine infusion
Other Name: Fludarabine monophosphate
Drug: Cyclophosphamide
Cyclophosphamide infusion
Other Name: Cytoxan
| Study group | Role | What they receive |
|---|---|---|
| Safety Evaluation Phase | Experimental | Treatment with NEXI-001 T cells, derived from PBMCs of original HLA- matched HCT donor. Receives: Biological: Infusion of NEXI-001 T Cells |
| Dose Expansion Phase | Experimental | Dose Expansion Phase to further define the safety, tolerability and initial anti-tumor efficacy of the NEXI-001 T cell product at the dose established from the Safety Evaluation Phase. Receives: Biological: Infusion of NEXI-001 T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of Special Interest (AESIs) events
Dose Limiting Toxicities (DLTs)
Measured: At year 1
Adverse Events of Special Interest (AESIs) events
For Incidence of TEAEs and serious TEAEs (Treatment-emergent adverse events (TEAEs) are defined as those AEs that started on or after LD therapy or that worsened after LD therapy
Measured: At year 1
Adverse Events of Special Interest (AESIs) events (AEs)
Infusion Related Reactions (IRR)
Measured: At year1
Survival
Median Progressive free Survival (PFS)
Measured: At 12 months
Survival
Overall Response Rate (ORR)
Measured: At 12 months
Survival
Overall Survival (OS)
Measured: At 12 months
Adverse events (AEs) Reporting
Incidence of TEAEs leading to study withdrawal
Measured: At year 1
Adverse Events of Special Interest (AESIs) events (AEs) Reporting
Cytokine Release Syndrome (CRS)
Measured: At year 1
Adverse Events of Special Interest (AESIs)events (AEs) Reporting
Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Measured: At year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start20 Feb 2020
- Primary completionOct 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- There are two parts to this study. The initial Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-001 T cells. The second part of the study, the Dose Expansion Phase, to further define the safety and evaluate the initial efficacy of the NEXI-001 T cells at the dose established from the Safety Evaluation Phase.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NexImmune Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Varela, MD, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284228
- Sponsor's protocol ID
- NEXI-001-01
- Status last verified
- Jan 2024
- First submitted
- 3 Feb 2020
- Last updated
- 16 Jan 2024
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 / 2 Study to Evaluate the Safety, Tolerability and Initial Anti-Tumor Activity of Adoptively Transferred T Lymphocytes Targeting WT1, PRAME and Cyclin A1 AML or MDS Patients With Relapsed Disease After Matched Allogeneic HCT
- ClinicalTrials.gov ID
- NCT04284228
- Acronym / sponsor ID
- NEXI-001-01
- Keywords
- AML, MDS, HCT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- NexImmune Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 25 Feb 2020 (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.
This Research study is being done to characterize the safety, tolerability, and preliminary antitumor activity of the NEXI-001 T cell product (a new experimental therapy), which contains populations of CD8+ T cells targeting multiple leukemia associated antigen peptides in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have relapsed disease after an allogeneic hematopoietic cell transplant (HCT).
The study will enroll AML or MDS patients who have either Minimal Residual Disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allogeneic HCT. Patients who have had an HLA-mismatched or haploidentical allogeneic HCT will not be eligible to participate in this study. Eligible patients for this study must also have ≥ 50% T-cell chimerism from the original donor at the time study entry.
The enrolled patients will undergo bridging therapy for the purposes of disease control while the NEXI-001 T cell product is being manufactured. Choice of bridging therapy administered will be per the Investigator's discretion, but is limited to acceptable agents as specified in the protocol. Bridging therapy will be administered prior to lymphodepleting (LD) therapy, with the last dose of the bridging therapy administered ≥ 14 days prior to initiation of LD therapy. Within 72 hours after completing LD therapy, patients will receive a single IV infusion of the NEXI-001 T cell product.
Detailed description
The NEXI-001 is an adoptive cellular therapy product which contains populations of antigen-specific CD8+ T cells. The antigen-specific CD8+ T cells in the NEXI-001 T cell product are derived from Peripheral Blood Mononuclear Cells (PBMC) obtained from the original stem cell donor. During the manufacturing process, these cells are primed and expanded ex vivo using nano-size artificial Antigen Presenting Cells (aAPC) loaded with five leukemia associated antigen peptides in combination with a proprietary T cell enrichment and expansion process.
The NEXI-001 T cell product is restricted to patients that are HLA-A2.01 allele positive for this study.
There are two parts to this study, a Safety Evaluation Phase and a Dose Expansion Phase. The Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-001 T cell product, and will consist of Dose Escalation at two dose levels - each with cohorts of three patients.
When all three patients at Dose Level 1 have dosed and cleared the DLT period, three additional patients will be enrolled at Dose Level 2. When three patients have cleared the DLT period at the highest dose level, that dose will be advanced to the Dose Expansion Phase. The Dose Expansion Phase will enroll up to 16 additional patients to further define the safety and evaluate the initial anti-tumor efficacy of the NEXI- 001 T cell product at the dose established from the Safety Evaluation Phase.
All patients will enter a Post-Treatment Follow-Up period after infusion of the NEXI- 001 T cell product. During this phase, all patients will be monitored for AEs and followed for anti-leukemia response until the end of study visit is complete (up to one year).
Additional assessments for safety, disease status, and other secondary and exploratory endpoints will also be monitored during the follow-up period.
All patients will be followed for overall survival (OS) from time of disease progression until the last visit of the last patient. During this time, patients will be followed via telephone or other electronic contact at 12 week intervals for monitoring of OS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two parts to this study. The initial Safety Evaluation Phase will determine the safety and tolerability of a single dose of NEXI-001 T cells. The second part of the study, the Dose Expansion Phase, to further define the safety and evaluate the initial efficacy of the NEXI-001 T cells at the dose established from the Safety Evaluation Phase.
| Arm | Type | Receives |
|---|---|---|
| Safety Evaluation Phase | Experimental | Biological: Infusion of NEXI-001 T CellsTreatment with NEXI-001 T cells, derived from PBMCs of original HLA- matched HCT donor. |
| Dose Expansion Phase | Experimental | Biological: Infusion of NEXI-001 T CellsDose Expansion Phase to further define the safety, tolerability and initial anti-tumor efficacy of the NEXI-001 T cell product at the dose established from the Safety Evaluation Phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- General
- Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens
- Age ≥ 18 years old
- Expression of HLA-A*0201 as determined by high resolution sequence-based typing method (e.g. TruSight HLA v2 Sequence Panel)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (29 listed)
- Active acute or chronic graft versus host disease (GvHD)
- Have active or uncontrolled infections with positive cultures and/or requiring treatment with IV anti-infective agents
- History of clinically significant cardiovascular disease including but not limited to:
- Clinically significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
- History of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus erythematosus, etc.) resulting in end organ injury or requiring systemic immunosuppression / systemic disease modifying agents within the last 2 years prior to enrollment. Subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and subjects with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for the study
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 |
|---|---|---|
| Infusion of NEXI-001 T CellsProcedure: A single IV infusion of NEXI-001 T Cells at Day 1 after Lymphodepletion(LD) Therapy. At dose Level 1: 1.0 x 108 total viable T cells At dose Level 2: 2.0 x 108 total viable T cells Procedure: Lymphodepletion: IV administration of fludarabine 30 mg/2 and cyclophosphamide 300 mg/m2 for 3 days. lymphodepletion (LD) Therapy: Subjects will received bridging therapy agents during lymphodepletion for 3 consecutive days prior to receiving the NEXI-001 product Drug: Fludarabine Fludarabine infusion Other Name: Fludarabine monophosphate Drug: Cyclophosphamide Cyclophosphamide infusion Other Name: Cytoxan | Biological | Dose Expansion Phase, Safety Evaluation Phase |
Primary outcome
Adverse Events of Special Interest (AESIs) events
Time frame: At year 1
Dose Limiting Toxicities (DLTs)
Adverse Events of Special Interest (AESIs) events
Time frame: At year 1
For Incidence of TEAEs and serious TEAEs (Treatment-emergent adverse events (TEAEs) are defined as those AEs that started on or after LD therapy or that worsened after LD therapy
Adverse Events of Special Interest (AESIs) events (AEs)
Time frame: At year1
Infusion Related Reactions (IRR)
Survival
Time frame: At 12 months
Median Progressive free Survival (PFS)
Survival
Time frame: At 12 months
Overall Response Rate (ORR)
Survival
Time frame: At 12 months
Overall Survival (OS)
Adverse events (AEs) Reporting
Time frame: At year 1
Incidence of TEAEs leading to study withdrawal
Adverse Events of Special Interest (AESIs) events (AEs) Reporting
Time frame: At year 1
Cytokine Release Syndrome (CRS)
Adverse Events of Special Interest (AESIs)events (AEs) Reporting
Time frame: At year 1
Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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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.
Juan Varela, MD, PhD principal investigator
Principal Investigator
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infusion of NEXI-001 T Cells in people with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), run by NexImmune Inc. at 5 sites 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 20 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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 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 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?
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?
Adverse Events of Special Interest (AESIs) events (time frame: At year 1). The study lists 9 primary outcomes in all. 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 16 Jan 2024; AzTrials last refreshed its copy on 1 Nov 2026.