Pancreatic CancerPhase 1/2TACTOPSNCT03192462
TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer
A Phase 1/2 study testing multiTAA specific T cells in people with Pancreatic Cancer, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
Status - CLOSED TO PATIENT ENROLLMENT (CNPE) Patients who have pancreatic cancer that has come back or has not gone away after treatment, including the standard treatment for this disease or patients who are not eligible for or have elected not to receive standard of care chemotherapy, and patients who will have… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- multiTAA specific T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jan 2018to 31 Jul 2025
- 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
- PROCUREMENT:
- Any patient with biopsy proven pancreatic adenocarcinoma.
- Patients with life expectancy greater than or equal to 6 months.
- Age greater than or equal to 18 years
- Hgb greater than or equal to 7.0 g/dl (transfusions allowed)
- TREATMENT:
Show all 21Show fewer
- Any patient with biopsy-proven pancreatic adenocarcinoma:
- Group A: Patients with locally advanced or metastatic adenocarcinoma who are responding (defined as stable disease or tumor volume reduction) following 3 cycles of first line chemotherapy
- Group B: Patients with locally advanced or metastatic adenocarcinoma who have failed first line chemotherapy or are intolerant, ineligible or unwilling to receive standard of care chemotherapy
- Group C: Patients with resectable pancreatic cancer who have completed planned neo-adjuvant chemotherapy, radiotherapy or combination
- Patients must have measurable or evaluable disease per RECIST 1.1 criteria.
- Patients with life expectancy greater than or equal to 12 weeks
- Age greater than or equal to 18
- Pulse oximetry of greater than 95 percent on room air in patients who previously received radiation therapy
- Patients with an ECOG score of ≤ 2 or Karnofsky score of 50 or greater
- Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, Hgb greater than or equal to 7.0 g/dl (transfusion allowed).
- Patients with a creatinine less than or equal to 2x upper limit of normal for age
- Patients should have been off other investigational therapy for one month prior to receiving treatment on this study.
- For Groups B or C patients must be off conventional therapy for at least 1 week prior to receiving treatment on this study.
- Informed Consent explained to, understood by and signed by patient. Patient given copy of informed consent.
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation.
Who cannot join
- PROCUREMENT:
- Patients with severe intercurrent infection.
- Patients with active HIV infection (can be pending at this time)
- TREATMENT:
- Patients with severe intercurrent infection.
- Patients receiving systemic corticosteroids (Patients off steroids for at least 48 hours are eligible)
- Pregnant
- HIV positive
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor Clinic
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Harris Health System - Smith Clinic
Houston, Texas, 77054
About this study
Official title: Tumor-Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Pancreatic Cancer
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
Patients who have pancreatic cancer that has come back or has not gone away after treatment, including the standard treatment for this disease or patients who are not eligible for or have elected not to receive standard of care chemotherapy, and patients who will have surgery after treatment for pancreatic cancer are eligible for this study. This is a research study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.
Read more
The proteins that are targeted in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, five common TAAs will be targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe.
Investigators now want to try this treatment in patients with pancreatic cancer.
These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration.
*Arm A and Arm B are closed to new patient enrollment.*
Read the detailed description
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
The patient will give blood to make TAA-Specific cytotoxic T cells in a lab. These cells well be grown and frozen. If the TAA-Specific cytotoxic T cells can be made, the time from collection of the blood to manufacture of T cells for administration to the patient is about 1 to 2 months.
The cells will be infused by intravenous infusion (IV) into the patient over 1-10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the TAA-CTL administration.
Patients will be given up to six doses of TAA-CTLs at monthly intervals. The treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital (HMH).
MEDICAL TESTS BEFORE TREATMENT:
- Physical exam.
- Blood tests to measure blood cells, kidney and liver function.
- Measurements of the patient's tumor by routine imaging studies and/or blood tests. The study will use the imaging study that was used before to follow the patient's tumor: CT, MRI, or PET.
- Blood test to check for pregnancy for female patients who can have children
MEDICAL TESTS DURING TREATMENT:
Standard medical tests will be conducted on the day of the second and subsequent infusions:
- Physical exams prior to each T cell infusion
- Blood tests to measure blood cells, kidney and liver function.
MEDICAL TESTS AFTER TREATMENT:
- Measurements the patient's tumor by routine imaging studies and/or blood tests done as per standard of care.
To learn more about the way the TAA-CTLs are working in patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before the infusion, at Weeks 1 and 2 after each infusion and at weeks 4, 6 and 8 and months 3, 6, 9 and 12 after the last infusion. The blood may be drawn from a central line at the time of the patient's regular blood tests. Investigators will use this blood to see how long the TAA-CTLs last, and to look at the immune system response to the patient's cancer.
Study Duration: Patients will be active participants in this study for approximately one year after their last dose. Investigators will contact patients once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate disease response long-term.
*Arm A and Arm B are closed to new patient enrollment.*
- Conditions
- Pancreatic Cancer
- Being tested
- multiTAA specific T cells
- Keywords
- Pancreatic Cancer, Immune-based therapies, CytotoxicT Lymphocytes
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiTAA specific T cellsBiological
Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Closed to New Patient Enrollment) | Experimental | Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. Receives: Biological: multiTAA specific T cells |
| Group B (Closed to New Patient Enrollment) | Experimental | Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. Receives: Biological: multiTAA specific T cells |
| Group C (Closed to New Patient Enrollment) | Experimental | Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. Receives: Biological: multiTAA specific T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment Related Serious Adverse Events
To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.
Measured: 7 months
Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells
To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease
Measured: 6 months
Secondary outcomes (2)
Progression Free Survival Using the Kaplan-Meier Method
To evaluate the progression-free of patients after multiTAA-specific T cell infusions. Progression-free survival (PFS) was estimated using the Kaplan-Meier method and summarized with median survival times and 95% confidence intervals. PFS was defined as the time from the first infusion to the first occurrence of disease progression, relapse, or death from any cause. Patients without events were censored at the last follow-up date.
Measured: 5 years
Overall Survival Using the Kaplan-Meier Method
To evaluate the overall survival of patients after multiTAA-specific T cell infusions. Overall survival (OS) was estimated using the Kaplan-Meier method and summarized with median survival times and 95% confidence intervals. OS was defined as the time from the first infusion to death from any cause. Patients without events were censored at the last follow-up date.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start18 Jan 2018
- Primary completion15 Jun 2020
- Study completion31 Jul 2025
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 Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a fixed-dose pilot study to evaluate the safety and feasibility and efficacy of up to 6 intravenous infusions of multiTAA-specific T cells in pancreas cancer patients with metastatic, locally advanced unresectable, or resectable disease.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute, Pancreatic Cancer Action Network, The V Foundation for Cancer Research, Harris County Hospital District
- Responsible party
- Principal investigator, Benjamin Leon Musher, Baylor College of Medicine
- Investigators
- Anne Leen, PhD, Principal investigator, Baylor College of MedicineBenjamin Musher, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192462
- Sponsor's protocol ID
- H-40378 TACTOPS
- Acronym
- TACTOPS
- Status last verified
- Oct 2025
- First submitted
- 16 Jun 2017
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Musher BL, Vasileiou S, Smaglo BG, Robertson CS, Wu M, Wang T, Watanabe A, Kuvalekar M, Velazquez Y, Ketkar S, Doheyan TA, Papayanni PG, Shah A, Lapteva N, Grilley BJ, Van Buren G, Lulla PD, Heslop HE, Rooney CM, Brenner MK, Leen AM. Autologous multiantigen-targeted T cell therapy for pancreatic cancer: a phase 1/2 trial. Nat Med. 2026 Jan;32(1):258-269. doi: 10.1038/s41591-025-04043-5. Epub 2026 Jan 2.
PubMed 41482561
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor-Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03192462
- Acronym / sponsor ID
- TACTOPS / H-40378 TACTOPS
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, Immune-based therapies, CytotoxicT Lymphocytes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute, Pancreatic Cancer Action Network, The V Foundation for Cancer Research, Harris County Hospital District
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
Patients who have pancreatic cancer that has come back or has not gone away after treatment, including the standard treatment for this disease or patients who are not eligible for or have elected not to receive standard of care chemotherapy, and patients who will have surgery after treatment for pancreatic cancer are eligible for this study. This is a research study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.
The proteins that are targeted in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, five common TAAs will be targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe.
Investigators now want to try this treatment in patients with pancreatic cancer.
These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration.
*Arm A and Arm B are closed to new patient enrollment.*
Detailed description
Status - CLOSED TO PATIENT ENROLLMENT (CNPE)
The patient will give blood to make TAA-Specific cytotoxic T cells in a lab. These cells well be grown and frozen. If the TAA-Specific cytotoxic T cells can be made, the time from collection of the blood to manufacture of T cells for administration to the patient is about 1 to 2 months.
The cells will be infused by intravenous infusion (IV) into the patient over 1-10 minutes. The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl). Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible allergic reaction to the TAA-CTL administration.
Patients will be given up to six doses of TAA-CTLs at monthly intervals. The treatments will be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital (HMH).
MEDICAL TESTS BEFORE TREATMENT:
- Physical exam.
- Blood tests to measure blood cells, kidney and liver function.
- Measurements of the patient's tumor by routine imaging studies and/or blood tests. The study will use the imaging study that was used before to follow the patient's tumor: CT, MRI, or PET.
- Blood test to check for pregnancy for female patients who can have children
MEDICAL TESTS DURING TREATMENT:
Standard medical tests will be conducted on the day of the second and subsequent infusions:
- Physical exams prior to each T cell infusion
- Blood tests to measure blood cells, kidney and liver function.
MEDICAL TESTS AFTER TREATMENT:
- Measurements the patient's tumor by routine imaging studies and/or blood tests done as per standard of care.
To learn more about the way the TAA-CTLs are working in patient's body, an extra 20-40 mL (4-8 teaspoons) of blood will be taken before the infusion, at Weeks 1 and 2 after each infusion and at weeks 4, 6 and 8 and months 3, 6, 9 and 12 after the last infusion. The blood may be drawn from a central line at the time of the patient's regular blood tests. Investigators will use this blood to see how long the TAA-CTLs last, and to look at the immune system response to the patient's cancer.
Study Duration: Patients will be active participants in this study for approximately one year after their last dose. Investigators will contact patients once a year for up to 4 additional years (total of 5 years follow-up) in order to evaluate disease response long-term.
*Arm A and Arm B are closed to new patient enrollment.*
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is designed as a fixed-dose pilot study to evaluate the safety and feasibility and efficacy of up to 6 intravenous infusions of multiTAA-specific T cells in pancreas cancer patients with metastatic, locally advanced unresectable, or resectable disease.
| Arm | Type | Receives |
|---|---|---|
| Group A (Closed to New Patient Enrollment) | Experimental | Biological: multiTAA specific T cellsPatients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4. |
| Group B (Closed to New Patient Enrollment) | Experimental | Biological: multiTAA specific T cellsPatients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells. |
| Group C (Closed to New Patient Enrollment) | Experimental | Biological: multiTAA specific T cellsPatients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Any patient with biopsy proven pancreatic adenocarcinoma.
- Patients with life expectancy greater than or equal to 6 months.
- Age greater than or equal to 18 years
- Hgb greater than or equal to 7.0 g/dl (transfusions allowed)
- Any patient with biopsy-proven pancreatic adenocarcinoma:
Key exclusion criteria (8 listed)
- Patients with severe intercurrent infection.
- Patients with active HIV infection (can be pending at this time)
- Patients with severe intercurrent infection.
- Patients receiving systemic corticosteroids (Patients off steroids for at least 48 hours are eligible)
- Pregnant
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 |
|---|---|---|
| multiTAA specific T cellsEach patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc. | Biological | Group A (Closed to New Patient Enrollment), Group B (Closed to New Patient Enrollment), Group C (Closed to New Patient Enrollment) |
Primary outcome
Number of Patients With Treatment Related Serious Adverse Events
Time frame: 7 months
To determine the safety of up to 6 intravenous infusions of multiTAA-specific T cells in pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease.
Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells
Time frame: 6 months
To determine the feasibility of completing a total of 6 intravenous infusions of multiTAA-specific T cells to pancreatic cancer patients with metastatic, locally advanced unresectable, or resectable disease
2 secondary outcomes
Progression Free Survival Using the Kaplan-Meier Method
Time frame: 5 years
Overall Survival Using the Kaplan-Meier Method
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41482561Musher BL, Vasileiou S, Smaglo BG, Robertson CS, Wu M, Wang T, Watanabe A, Kuvalekar M, Velazquez Y, Ketkar S, Doheyan TA, Papayanni PG, Shah A, Lapteva N, Grilley BJ, Van Buren G, Lulla PD, Heslop HE, Rooney CM, Brenner MK, Leen AM. Autologous multiantigen-targeted T cell therapy for pancreatic cancer: a phase 1/2 trial. Nat Med. 2026 Jan;32(1):258-269. doi: 10.1038/s41591-025-04043-5. Epub 2026 Jan 2.
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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.
Anne Leen, PhD principal investigator
Baylor College of Medicine
Benjamin Musher, MD principal investigator
Baylor College of Medicine
3 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 multiTAA specific T cells in people with Pancreatic Cancer, run by Baylor College of Medicine at 3 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 21 inclusion and 8 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: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 1 Aug 2023). 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?
Number of Patients With Treatment Related Serious Adverse Events (time frame: 7 months). 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 NCT03192462, 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 29 Oct 2025.