Non Hodgkin LymphomaPhase 1NCT04240808
Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)
A Phase 1 study testing UCD19 CAR T Cells in people with Non Hodgkin Lymphoma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will test whether immune cells modified to recognize B-cell non-Hodgkin lymphoma (NHL) can be successfully manufactured at the University of Colorado Anschutz and whether these cells can be administered with an acceptable safety profile. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- UCD19 CAR T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2020to 23 Oct 2023
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated Informed Consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the parent study and the long-term follow-up observational study.
- Male or non-pregnant, non-lactating females, aged 18 to 80 years.
- Performance status according to the Eastern Cooperative Oncology Group ≤ 2.
- Failed two or more lines of systemic therapy.
- Unable to receive commercially available CD19 CAR T Cells.
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- Relapsed or primary refractory CD19 positive (i.e. CD19 expressing) B-NHL of the following types as confirmed by either flow cytometry, Immunohistochemistry (IHC), or both:
- Diffuse large B-cell lymphoma (DLBCL)
- Burkitt lymphoma
- Intermediate lymphoma between Burkitt and DLBCL
- Primary Mediastinal B-cell lymphoma (PMBL)
- Follicular lymphoma
- Mantle cell lymphoma (MCL)
- Marginal zone lymphoma (MZL)
- No available curative alternative treatment, as determined by primary treating oncologist.
- No active Graft-versus-Host Disease (GvHD).
- In women of childbearing potential, willingness to use effective means of birth control for 1 year after UCD19 CAR T Cell infusion.
Who cannot join
- Prior therapies:
- Received monoclonal antibody therapy within 14 days of the apheresis; or
- Received immunomodulatory drugs (lenalidomide, tyrosine kinase inhibitors) within 14 days of the apheresis; or
- Received corticosteroids more than 7.5mg/day within 14 days of the apheresis (physiologic replacement allowed up until apheresis, as clinically indicated); or
- Allogeneic hematopoietic stem cell transplant with 90 days (immunosuppressive therapy for at least 4 weeks) of apheresis; or
- Donor lymphocyte infusion within 4 weeks of apheresis.
Show all 21Show fewer
- Cluster of differentiation 3 (CD3) count <0.15 x 106 cells/mL
- Severe psychiatric illness that could impede the patient's ability to provide informed consent and/or adhere to the parent protocol and/or the long-term follow-up protocol.
- Active HIV (Acquired Immune Deficiency Syndrome) or history of HIV infection, as directed by schedule or if known.
- Active Hepatitis B or Hepatitis C infection.
- Diffusion capacity of the lungs for carbon monoxide < 40% predicted prior to lymphodepletion.
- Left ventricular ejection fraction < 40% (evaluated by echocardiogram [ECHO] or Multigated Acquisition Scan [MUGA]) prior to lymphodepletion.
- Transaminases > 5x upper limit of normal prior to lymphodepletion.
- Serum Bilirubin > 4 mg/dL prior to lymphodepletion.
- Serum Creatinine > 1.6 mg/dL or measured creatinine clearance < 50 mL/min prior to lymphodepletion.
- Active infection that is unresponsive to antimicrobial therapy prior to lymphodepletion.
- Females planning to become pregnant during the course of the study.
- Unwillingness or inability to comply with study visits and study procedures for the entire duration of study participation.
- Unsuitable for cellular therapy for any reason, in the opinion of the Investigator.
- Any prior gene therapy, including prior CAR T cell therapy.
- Active central nervous system (CNS) disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Phase I Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)
This study will test whether immune cells modified to recognize B-cell non-Hodgkin lymphoma (NHL) can be successfully manufactured at the University of Colorado Anschutz and whether these cells can be administered with an acceptable safety profile. Adults who have been diagnosed with B-cell non-Hodgkin lymphoma (NHL) that has relapsed or no longer responds to chemotherapy (relapsed or refractory) may be eligible to participate in this study.
The investigators will use participants own immune cells, called T cells, to kill the lymphoma. These T cells are involved in fighting infections and in some cases, can also kill cancer cells. The investigators will extract T cells from the participant's blood, modify the cells in a laboratory, and then return teh cells to the participant's body via intravenous (IV) injection. In the laboratory, the investigators will add a new gene into the T cells that allows the T cells to recognize and kill the lymphoma cells, and allows these modified cells to multiply and increase in numbers. To put the new gene into your T cells, the investigators will use a weakened virus. The virus is modified so that it cannot multiply or spread once the cells are infused.
Read the detailed description
The objective of this Phase 1 open-label study is to assess the feasibility of UCD19 Chimeric Antigen Receptor (CAR) T Cells manufacture onsite, successful infusion of eligible subjects, and safety of UCD19 CAR T Cells infusion in subjects with relapsed/refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL).
Six (6) subjects will participate in the initial cohort of this open-label, single arm, single site study to assess dose-limiting toxicity (DLT) and safety; the first set of 3 subjects will initiate treatment with lymphodepleting chemotherapy prior to CAR T cell infusion staggered 30 days from CAR T cell dosing of the previously treated subject. Depending on the assessment of DLTs, the second set of 3 subjects may be enrolled and dosed without stagger.
After the initial 6 subjects have received treatment, an additional 14 subjects will participate in the Phase 1 expansion study.
Participants will include adults with relapsed/ primary refractory CD19 positive (i.e. CD19 expressing) B-NHL as confirmed by either flow cytometry, immunohistochemistry (IHC), or both who are not candidates for other curative forms of therapy. Enrolled participants will receive lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector [LV] Transduced Autologous Peripheral Blood Lymphocytes). Participants will be enrolled up to 1 month before anticipated date of apheresis, and will be considered completed at 12 months post-treatment.
Long Term Follow Up will be conducted under a separate protocol and will occur for up to 15 Years to collect data on the long-term safety of UCD19 CAR T Cells, and for the observation, detection, and evaluation of latent adverse reactions including secondary malignancies.
While this study focuses on primary endpoints for feasibility of the manufacturing and infusion processes and safety of the administered UCD19 CAR T Cells, preliminary evidence of effectiveness will be collected and analyzed for use in planning future CAR T cell therapy studies.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- UCD19 CAR T Cells
- Keywords
- Car T, Car T Cells, Cancer, B-Cell Non-Hodgkin's Lymphoma, B-NHL
- Medical subject headings
- Lymphoma, Non-Hodgkin, Neoplasms, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCD19 CAR T CellsBiological
Lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector [LV] Transduced Autologous Peripheral Blood Lymphocytes)
| Study group | Role | What they receive |
|---|---|---|
| UCD19 CAR T Cells | Experimental | Participants will receive lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector [LV] Transduced Autologous Peripheral Blood Lymphocytes Receives: Biological: UCD19 CAR T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Successful manufacture of UCD19 CAR T Cells, as determined by the number of successfully manufactured doses
The successful manufacture of UCD19 Chimeric Antigen Receptor (CAR) T Cells onsite meeting the IND-defined release criteria. Manufacture of UCD19 CAR T Cells will begin after enrollment and be completed within 1 month. Success will be determined by whether or not the participant's CAR T Cell count meets the target dose required for infusion at Day 0. The number of successfully manufactured doses will be reported.
Measured: Day 0 (infusion)
Feasibility: Percent of Participants successfully infused with UCD19 CAR T Cells
The percent of participants who are able to receive an infusion of UCD19 CAR T cells.
Measured: Day 0 (infusion)
Safety: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) within 30 days after treatment
The number of subjects who receive UCD19 CAR T Cells and experience a DLT within 30 days after treatment, as defined herein using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Measured: Up to 30 Days Post-Infusion
Safety: Percent of Participants Who Experience a Dose Limiting Toxicity (DLT) within 30 days after treatment
The percent of all subjects who receive UCD19 CAR T Cells and experience a DLT within 30 days after treatment, as defined herein using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Measured: Up to 30 Days Post-Infusion
Secondary outcomes (8)
Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 90 days
The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 90 days post-treatment, as determined by the investigators.
Measured: 90 Days Post-Infusion
Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 6 Months
The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 6 months post-treatment, as determined by the investigators.
Measured: 6 Months Post-Infusion
Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 1 Year
The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 1 Year post-treatment, as determined by the investigators.
Measured: 1 Year Post-Infusion
Efficacy: Rate of participants with Complete Response at 6 Months
Measured: 6 Months Post-Infusion
Efficacy: Rate of participants with Complete Response at 1 Year
Measured: 1 Year Post-Infusion
Efficacy: Median Duration of Remission at 1 Year
Measured: 1 Year Post-Infusion
Efficacy: Progression Free Survival (PFS) at 1 Year
Number of participants with Progression Free Survival (PFS) at 1 year post-infusion.
Measured: 1 Year Post-Infusion
Efficacy: Overall Survival (OS) at 1 Year
Number of participants surviving at 1 year post-infusion.
Measured: 1 Year Post-Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start17 Jul 2020
- Primary completion24 Mar 2023
- Study completion23 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Verneris, MD, Study director, University of Colorado Denver, Anschutz Medical CampusManali Kamdar, MD, Principal investigator, University of Colorado Denver, Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240808
- Sponsor's protocol ID
- 19-2807
- Status last verified
- May 2025
- First submitted
- 22 Jan 2020
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bair SM, Pinto N, Roth A, Verneris M, Haverkos B, Nicklawsky A, Ohm A, Jordan K, Murphy LA, Marians R, Mallo R, Orentas R, Adams C, Kamdar M, Fry T. Feasibility and Safety of a Novel CD19-Directed CAR T-Cell Therapy in Patients with R/R B-Cell Non-Hodgkin Lymphoma. Transplant Cell Ther. 2026 Jun 3:S2666-6367(26)00447-1. doi: 10.1016/j.jtct.2026.06.002. Online ahead of print.
PubMed 42242517
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL)
- ClinicalTrials.gov ID
- NCT04240808
- Acronym / sponsor ID
- 19-2807
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- Car T, Car T Cells, Cancer, B-Cell Non-Hodgkin's Lymphoma, B-NHL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 17 Jul 2020 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 23 Oct 2023 (actual)
- First posted
- 27 Jan 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 study will test whether immune cells modified to recognize B-cell non-Hodgkin lymphoma (NHL) can be successfully manufactured at the University of Colorado Anschutz and whether these cells can be administered with an acceptable safety profile. Adults who have been diagnosed with B-cell non-Hodgkin lymphoma (NHL) that has relapsed or no longer responds to chemotherapy (relapsed or refractory) may be eligible to participate in this study.
The investigators will use participants own immune cells, called T cells, to kill the lymphoma. These T cells are involved in fighting infections and in some cases, can also kill cancer cells. The investigators will extract T cells from the participant's blood, modify the cells in a laboratory, and then return teh cells to the participant's body via intravenous (IV) injection. In the laboratory, the investigators will add a new gene into the T cells that allows the T cells to recognize and kill the lymphoma cells, and allows these modified cells to multiply and increase in numbers. To put the new gene into your T cells, the investigators will use a weakened virus. The virus is modified so that it cannot multiply or spread once the cells are infused.
Detailed description
The objective of this Phase 1 open-label study is to assess the feasibility of UCD19 Chimeric Antigen Receptor (CAR) T Cells manufacture onsite, successful infusion of eligible subjects, and safety of UCD19 CAR T Cells infusion in subjects with relapsed/refractory B-Cell Non-Hodgkin's Lymphoma (B-NHL).
Six (6) subjects will participate in the initial cohort of this open-label, single arm, single site study to assess dose-limiting toxicity (DLT) and safety; the first set of 3 subjects will initiate treatment with lymphodepleting chemotherapy prior to CAR T cell infusion staggered 30 days from CAR T cell dosing of the previously treated subject. Depending on the assessment of DLTs, the second set of 3 subjects may be enrolled and dosed without stagger.
After the initial 6 subjects have received treatment, an additional 14 subjects will participate in the Phase 1 expansion study.
Participants will include adults with relapsed/ primary refractory CD19 positive (i.e. CD19 expressing) B-NHL as confirmed by either flow cytometry, immunohistochemistry (IHC), or both who are not candidates for other curative forms of therapy. Enrolled participants will receive lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector [LV] Transduced Autologous Peripheral Blood Lymphocytes). Participants will be enrolled up to 1 month before anticipated date of apheresis, and will be considered completed at 12 months post-treatment.
Long Term Follow Up will be conducted under a separate protocol and will occur for up to 15 Years to collect data on the long-term safety of UCD19 CAR T Cells, and for the observation, detection, and evaluation of latent adverse reactions including secondary malignancies.
While this study focuses on primary endpoints for feasibility of the manufacturing and infusion processes and safety of the administered UCD19 CAR T Cells, preliminary evidence of effectiveness will be collected and analyzed for use in planning future CAR T cell therapy studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCD19 CAR T Cells | Experimental | Biological: UCD19 CAR T CellsParticipants will receive lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector [LV] Transduced Autologous Peripheral Blood Lymphocytes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Provision of signed and dated Informed Consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the parent study and the long-term follow-up observational study.
- Male or non-pregnant, non-lactating females, aged 18 to 80 years.
- Performance status according to the Eastern Cooperative Oncology Group ≤ 2.
- Failed two or more lines of systemic therapy.
Key exclusion criteria (21 listed)
- Prior therapies:
- Severe psychiatric illness that could impede the patient's ability to provide informed consent and/or adhere to the parent protocol and/or the long-term follow-up protocol.
- Active HIV (Acquired Immune Deficiency Syndrome) or history of HIV infection, as directed by schedule or if known.
- Active Hepatitis B or Hepatitis C infection.
- Diffusion capacity of the lungs for carbon monoxide < 40% predicted prior to lymphodepletion.
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 |
|---|---|---|
| UCD19 CAR T CellsLymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector [LV] Transduced Autologous Peripheral Blood Lymphocytes) | Biological | UCD19 CAR T Cells |
Primary outcome
Feasibility: Successful manufacture of UCD19 CAR T Cells, as determined by the number of successfully manufactured doses
Time frame: Day 0 (infusion)
The successful manufacture of UCD19 Chimeric Antigen Receptor (CAR) T Cells onsite meeting the IND-defined release criteria. Manufacture of UCD19 CAR T Cells will begin after enrollment and be completed within 1 month. Success will be determined by whether or not the participant's CAR T Cell count meets the target dose required for infusion at Day 0. The number of successfully manufactured doses will be reported.
Feasibility: Percent of Participants successfully infused with UCD19 CAR T Cells
Time frame: Day 0 (infusion)
The percent of participants who are able to receive an infusion of UCD19 CAR T cells.
Safety: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) within 30 days after treatment
Time frame: Up to 30 Days Post-Infusion
The number of subjects who receive UCD19 CAR T Cells and experience a DLT within 30 days after treatment, as defined herein using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Safety: Percent of Participants Who Experience a Dose Limiting Toxicity (DLT) within 30 days after treatment
Time frame: Up to 30 Days Post-Infusion
The percent of all subjects who receive UCD19 CAR T Cells and experience a DLT within 30 days after treatment, as defined herein using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0).
8 secondary outcomes
Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 90 days
Time frame: 90 Days Post-Infusion
Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 6 Months
Time frame: 6 Months Post-Infusion
Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 1 Year
Time frame: 1 Year Post-Infusion
Efficacy: Rate of participants with Complete Response at 6 Months
Time frame: 6 Months Post-Infusion
Efficacy: Rate of participants with Complete Response at 1 Year
Time frame: 1 Year Post-Infusion
Efficacy: Median Duration of Remission at 1 Year
Time frame: 1 Year Post-Infusion
Efficacy: Progression Free Survival (PFS) at 1 Year
Time frame: 1 Year Post-Infusion
Efficacy: Overall Survival (OS) at 1 Year
Time frame: 1 Year Post-Infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 42242517Bair SM, Pinto N, Roth A, Verneris M, Haverkos B, Nicklawsky A, Ohm A, Jordan K, Murphy LA, Marians R, Mallo R, Orentas R, Adams C, Kamdar M, Fry T. Feasibility and Safety of a Novel CD19-Directed CAR T-Cell Therapy in Patients with R/R B-Cell Non-Hodgkin Lymphoma. Transplant Cell Ther. 2026 Jun 3:S2666-6367(26)00447-1. doi: 10.1016/j.jtct.2026.06.002. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Verneris, MD study director
University of Colorado Denver, Anschutz Medical Campus
Manali Kamdar, MD principal investigator
University of Colorado Denver, Anschutz Medical Campus
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 UCD19 CAR T Cells in people with Non Hodgkin Lymphoma, run by University of Colorado, Denver 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 17 inclusion and 21 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 15 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility: Successful manufacture of UCD19 CAR T Cells, as determined by the number of successfully manufactured doses (time frame: Day 0 (infusion)). The study lists 4 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 NCT04240808, 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 15 May 2025.