Relapsed/Refractory Multiple MyelomaPhase 1NCT04171843
A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing PBCAR269A, Fludarabine and Cyclophosphamide in people with Relapsed/Refractory Multiple Myeloma, run by Precision BioSciences, Inc. at 5 sites in United States.
Trial summary
This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A, with or without nirogacestat, in adults with r/r MM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- PBCAR269A, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Apr 2020to 19 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MM with relapsed and/or refractory disease according to the IMWG criteria.
- Measurable disease at Screening including at least 1 of the criteria below. Note: Study participants with immunoglobulin (Ig) A myeloma in whom serum protein electrophoresis is deemed unreliable due to comigration of normal serum proteins with the paraprotein in the beta region may be considered eligible provided total serum IgA level is >400 mg/dL.
- Serum myeloma (M)-protein ≥0.5 g/dL or, urine M-protein >200 mg/24 hour.
- Serum free light chain >10mg/dL with abnormal kappa:lambda ratio.
- Imaging consistent plasmacytoma and the presence of any clonal plasma cells in peripheral blood or bone marrow.
- Study participants must be refractory to 2 prior MM treatment regimens including an immunomodulatory imide drug and a protease inhibitor prior to entering the study. Study participants must have recovered or stabilized to Grade ≤2 from any AEs experienced during prior treatment with the exception of neuropathy. Prior therapy requirements are as follows:
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- Undergone ≥1 complete cycle of treatment for each regimen, unless progressive disease was the best response to the regimen.
- Must have received an immunomodulatory agent, a proteasome inhibitor, and an anti- CD38 antibody.
- Study participants who are not candidates for ≥1 of the above treatments may still be considered eligible.
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
- Estimated glomerular filtration rate >30 mL/min/1.73 m2. A 24-hour urine collection for creatinine clearance may be used at the investigator's discretion.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels both
- ≤3 times of upper limit of normal, unless there is suspected disease in the liver, in which case, no limit is set provided serum bilirubin is within eligibility criterion.
- Total bilirubin <2.0 mg/dL, except in study participants with Gilbert's syndrome.
- Platelet count >50,000/μL (platelet transfusions acceptable); neutrophils >750/μL.
- Left ventricular ejection fraction (LVEF) >45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan performed within 1 month before starting lymphodepleting chemotherapy. ECHO results performed within 6 months before Screening and at least 28 days after the last cancer treatment may be acceptable if the study participant has not received any treatment with cardiotoxicity risks.
- No clinically significant evidence of pericardial effusion or pleural effusion based on investigator's opinion.
- Baseline oxygen saturation >92% on room air.
- Pulmonary function tests including forced expiratory volume at 1 sec, forced vital capacity, total lung capacity, diffusion capacity of lung for carbon monoxide ≥50% of predicted values. Study participant characteristics
- All study participants must be willing to practice birth control and refrain from donating sperm or oocytes from the time of enrollment in this study through 6 months after receiving the study treatment.
- Women of childbearing potential (WOCBP) must test negative for pregnancy at Screening because of the potentially harmful effects of the preparative chemotherapy to the fetus. WOCBP are defined as any women who are not postmenopausal or who have not had a hysterectomy. Postmenopausal is defined as women over the age of 55 who have not had a menstrual period for ≥1 year.
- Capable of giving signed informed consent.
Who cannot join
- Study participant has clinically significant organ involvement by amyloid protein.
- Study participant has plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome.
- History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months of starting study treatment.
- History or presence of clinically relevant central nervous system (CNS) pathology.
- Active uncontrolled fungal, bacterial, viral, protozoal, or other infection.
- Any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease).
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- History of human immunodeficiency virus (HIV) infection.
- Active hepatitis B or hepatitis C confirmed by polymerase chain reaction (PCR). Study participant positive for inactive hepatitis B will be allowed to enroll if on prophylactic treatment.
- History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening.
- History of severe immediate hypersensitivity reaction to any of the agents used in this study.
- Abnormal findings during the Screening Period or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the study participant's safety.
- History of genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or any other known bone marrow failure syndrome.
- Study participants with active hemolytic anemia.
- Study participant has received autologous stem cell transplant within 12 weeks of Screening or an allogeneic stem cell transplant within 6 months of starting study treatment. Study participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of GvHD.
- Study participants with second malignancies in addition to MM if the second malignancy has required treatment within the last 3 years or is not in complete remission, with the exception of non-metastatic basal cell or squamous cell skin carcinoma.
- Study participant has received systemic biologic agent within 28 days. Participation in non-interventional registries or epidemiological studies is not excluded.
- Study participant has received live vaccine within 4 weeks before Screening. Non-live virus vaccines are not excluded.
- Before initiation of lymphodepletion, study participants must have recovered or stabilized to Grade ≤2 from any AEs experienced during prior treatment with the exception of neuropathy.
- Radiotherapy within 4 weeks before Screening should be discussed with the monitor.
- Presence of pleural/peritoneal/pericardial catheter.
- Current use of any anticoagulant or antiplatelet therapy.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
City of Hope
Duarte, California, 91010
MD Anderson
Houston, Texas, 77030
Columbia University Irving Medical Center
New York, New York, 10032
University of California San Francisco
San Francisco, California, 94115
About this study
Official title: A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma
This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A, with or without nirogacestat, in adults with r/r MM. Study subjects in Cohort A will receive PBCAR269A and study subjects in Cohort B will receive PBCAR269A and nirogacestat. At each dose level, study subjects in Cohort A and Cohort B will receive the same dose of PBCAR269A. In Cohort B, all study subjects will follow the same dosing regimen of nirogacestat. This study was terminated prior to beginning of Phase II due to lack of sufficient therapeutic effect
Read the detailed description
This is a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A, with or without nirogacestat, in adults with r/r MM. Before initiating the study treatment PBCAR269A, all study participants will be administered lymphodepletion chemotherapy. The initial lymphodepletion chemotherapy regimen will be composed of fludarabine and cyclophosphamide during the Screening Period. Study subjects in Cohort B will also receive nirogacestat. On Day 0 of the Treatment Period, study participants will receive a single intravenous (IV) infusion of PBCAR269A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of PBCAR269A, with or without nirogacestat, will be followed in a separate long-term follow-up (LTFU) study for 15 years after exiting this study.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- PBCAR269A, Fludarabine, Cyclophosphamide, Nirogacestat
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBCAR269AGenetic
Allogeneic anti-BCMA CAR T-cell
FludarabineDrug
Fludarabine is used for lymphodepletion.
CyclophosphamideDrug
Cyclophosphamide is used for lymphodepletion.
NirogacestatDrug
Allogeneic anti-BCMA CAR T-cell
| Study group | Role | What they receive |
|---|---|---|
| PBCAR269A at Dose Level 1 (Cohort A) | Experimental | The starting dose of PBCAR269A will be 6 x 10^5 CAR T cells/kg body weight. Receives: Genetic: PBCAR269A; Drug: Fludarabine; Drug: Cyclophosphamide |
| PBCAR269A at Dose Level 2 | Experimental | 2 × 10^6 CAR T cells/kg body weight. Receives: Genetic: PBCAR269A; Drug: Fludarabine; Drug: Cyclophosphamide |
| PBCAR269A at Dose Level 3 | Experimental | 6 × 10^6 CAR T cells/kg body weight. Receives: Genetic: PBCAR269A; Drug: Fludarabine; Drug: Cyclophosphamide |
| PBCAR269A at Dose Level 2 (Cohort B) | Experimental | 2 × 10^6 CAR T cells/kg body weight. Receives: Genetic: PBCAR269A; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Nirogacestat |
| PBCAR269A at Dose Level 1 (Cohort B) | Experimental | 6 x 10^5 CAR T cells/kg body weight. Receives: Genetic: PBCAR269A; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Nirogacestat |
| PBCAR269A at Dose Level 3 (Cohort B) | Experimental | 6 × 10^6 CAR T cells/kg body weight. Receives: Genetic: PBCAR269A; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Nirogacestat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of PBCAR269A
To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy.
Measured: Day 1 - Day 28
Secondary outcomes (2)
Number of Participants with Dose Limiting Toxicity(ies)
To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0.
Measured: 1 year
Objective Response Rate of Patients
To assess ORR to treatment with PBCAR269A through Day 360 will be noted using the IMWG response criteria.
The ORR is defined as the proportion of study participants meeting the definition of response within the study population to the response evaluable population. ORR will be summarized by number and percentage of study participants meeting the definition of ORR along with the corresponding exact 95% CIs. DoR, defined as the duration (days) from initial response to disease relapse, progression, or death will be descriptively analyzed using Kaplan-Meier methods. The number of study participants achieving DoR at 3, 6, 9, and 12 months will also be calculated. Exploratory efficacy analyses include changes from Baseline in CBC counts, CAR T cells, cytokines, and CRP levels.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start30 Apr 2020
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
Why it stopped: Study was terminated due to lack of sufficient therapeutic effect
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In Phase I, 3 escalating dose groups will be enrolled and treated sequentially, with the possibility of a single de-escalation. Within each dose group, at least 3 and at most 6 study participants will be treated with a single dose of PBCAR269A using a standard 3 + 3 design. The starting dose of PBCAR269A will be 6 x 105 CAR T cells/kg body weight. Subsequent dose groups will be treated with escalating doses to a maximum dose of 6 x 106 CAR T cells/kg. In the absence of DLTs, the dose will be increased using a fixed-dose scheme.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Precision BioSciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monika Vainorius, MD, Study chair, Precision BioSciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171843
- Sponsor's protocol ID
- PBCAR269A-01
- Status last verified
- Sep 2023
- First submitted
- 12 Nov 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04171843
- Acronym / sponsor ID
- PBCAR269A-01
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of sufficient therapeutic effect
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Precision BioSciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 21 Nov 2019 (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 is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A, with or without nirogacestat, in adults with r/r MM. Study subjects in Cohort A will receive PBCAR269A and study subjects in Cohort B will receive PBCAR269A and nirogacestat. At each dose level, study subjects in Cohort A and Cohort B will receive the same dose of PBCAR269A. In Cohort B, all study subjects will follow the same dosing regimen of nirogacestat. This study was terminated prior to beginning of Phase II due to lack of sufficient therapeutic effect
Detailed description
This is a multicenter, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A, with or without nirogacestat, in adults with r/r MM. Before initiating the study treatment PBCAR269A, all study participants will be administered lymphodepletion chemotherapy. The initial lymphodepletion chemotherapy regimen will be composed of fludarabine and cyclophosphamide during the Screening Period. Study subjects in Cohort B will also receive nirogacestat. On Day 0 of the Treatment Period, study participants will receive a single intravenous (IV) infusion of PBCAR269A. All subjects are monitored during the treatment period through Day 28. All subjects who receive a dose of PBCAR269A, with or without nirogacestat, will be followed in a separate long-term follow-up (LTFU) study for 15 years after exiting this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- In Phase I, 3 escalating dose groups will be enrolled and treated sequentially, with the possibility of a single de-escalation. Within each dose group, at least 3 and at most 6 study participants will be treated with a single dose of PBCAR269A using a standard 3 + 3 design. The starting dose of PBCAR269A will be 6 x 105 CAR T cells/kg body weight. Subsequent dose groups will be treated with escalating doses to a maximum dose of 6 x 106 CAR T cells/kg. In the absence of DLTs, the dose will be increased using a fixed-dose scheme.
| Arm | Type | Receives |
|---|---|---|
| PBCAR269A at Dose Level 1 (Cohort A) | Experimental | Genetic: PBCAR269A, Drug: Fludarabine, Drug: CyclophosphamideThe starting dose of PBCAR269A will be 6 x 10^5 CAR T cells/kg body weight. |
| PBCAR269A at Dose Level 2 | Experimental | Genetic: PBCAR269A, Drug: Fludarabine, Drug: Cyclophosphamide2 × 10^6 CAR T cells/kg body weight. |
| PBCAR269A at Dose Level 3 | Experimental | Genetic: PBCAR269A, Drug: Fludarabine, Drug: Cyclophosphamide6 × 10^6 CAR T cells/kg body weight. |
| PBCAR269A at Dose Level 2 (Cohort B) | Experimental | Genetic: PBCAR269A, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Nirogacestat2 × 10^6 CAR T cells/kg body weight. |
| PBCAR269A at Dose Level 1 (Cohort B) | Experimental | Genetic: PBCAR269A, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Nirogacestat6 x 10^5 CAR T cells/kg body weight. |
| PBCAR269A at Dose Level 3 (Cohort B) | Experimental | Genetic: PBCAR269A, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Nirogacestat6 × 10^6 CAR T cells/kg body weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Diagnosis of MM with relapsed and/or refractory disease according to the IMWG criteria.
- Measurable disease at Screening including at least 1 of the criteria below. Note: Study participants with immunoglobulin (Ig) A myeloma in whom serum protein electrophoresis is deemed unreliable due to comigration of normal serum proteins with the paraprotein in the beta region may be considered eligible provided total serum IgA level is >400 mg/dL.
- Study participants must be refractory to 2 prior MM treatment regimens including an immunomodulatory imide drug and a protease inhibitor prior to entering the study. Study participants must have recovered or stabilized to Grade ≤2 from any AEs experienced during prior treatment with the exception of neuropathy. Prior therapy requirements are as follows:
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:
Key exclusion criteria (21 listed)
- Study participant has clinically significant organ involvement by amyloid protein.
- Study participant has plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome.
- History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months of starting study treatment.
- History or presence of clinically relevant central nervous system (CNS) pathology.
- Active uncontrolled fungal, bacterial, viral, protozoal, or other infection.
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 |
|---|---|---|
| PBCAR269AAllogeneic anti-BCMA CAR T-cell | Genetic | PBCAR269A at Dose Level 1 (Cohort A), PBCAR269A at Dose Level 1 (Cohort B), PBCAR269A at Dose Level 2, PBCAR269A at Dose Level 2 (Cohort B), PBCAR269A at Dose Level 3, PBCAR269A at Dose Level 3 (Cohort B) |
| FludarabineFludarabine is used for lymphodepletion. | Drug | PBCAR269A at Dose Level 1 (Cohort A), PBCAR269A at Dose Level 1 (Cohort B), PBCAR269A at Dose Level 2, PBCAR269A at Dose Level 2 (Cohort B), PBCAR269A at Dose Level 3, PBCAR269A at Dose Level 3 (Cohort B) |
| CyclophosphamideCyclophosphamide is used for lymphodepletion. | Drug | PBCAR269A at Dose Level 1 (Cohort A), PBCAR269A at Dose Level 1 (Cohort B), PBCAR269A at Dose Level 2, PBCAR269A at Dose Level 2 (Cohort B), PBCAR269A at Dose Level 3, PBCAR269A at Dose Level 3 (Cohort B) |
| NirogacestatAllogeneic anti-BCMA CAR T-cell | Drug | PBCAR269A at Dose Level 1 (Cohort B), PBCAR269A at Dose Level 2 (Cohort B), PBCAR269A at Dose Level 3 (Cohort B) |
Primary outcome
Maximum Tolerated Dose (MTD) of PBCAR269A
Time frame: Day 1 - Day 28
To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy.
2 secondary outcomes
Number of Participants with Dose Limiting Toxicity(ies)
Time frame: 1 year
Objective Response Rate of Patients
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study was terminated due to lack of sufficient therapeutic effect). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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.
Monika Vainorius, MD study chair
Precision BioSciences, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBCAR269A, Fludarabine and Cyclophosphamide in people with Relapsed/Refractory Multiple Myeloma, run by Precision BioSciences, 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 23 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: stopped early, as of the sponsor's last update on 21 Sep 2023. 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 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 was stopped early (reason given: Study was terminated due to lack of sufficient therapeutic effect). 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?
Maximum Tolerated Dose (MTD) of PBCAR269A (time frame: Day 1 - Day 28). 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 21 Sep 2023.