Hematologic MalignancyPhase 1NCT04136275
CAR-37 T Cells in Hematologic Malignancies
A Phase 1 study testing CAR-37 T cells in people with Hematologic Malignancy and Leukemia, run by Marcela V. Maus, M.D.,Ph.D. at 1 site in United States.
Trial summary
This research study is studying Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) for treating people with relapsed or refractory CD37+ hematologic malignancies and to understand the side effects when treated with CAR-37 T Cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Leukemia, Lymphoma
- What is being tested?
- CAR-37 T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2020to 1 Mar 2024
- 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
- Voluntarily sign informed consent form.
- Age ≥18 years of at the time of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Karnofsky ≥60%, see Appendix A)
- Diagnosis of relapsed/refractory (R/R) CD37+ hematologic malignancy as defined as one of the following:
- Mature B cell neoplasms
- Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a
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- RR disease after 2 or more prior lines of therapy AND
- 1 of the prior lines of therapy must include an anti-CD20 antibody monotherapy.
- Marginal Zone Lymphoma (MZL) nodal or extranodal:
- R/R disease after 2 or more prior lines of therapy AND
- 1 of the prior lines of therapy must include an anti-CD20 antibody monotherapy
- Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and grade 3b Follicular Lymphoma (FL).
- R/R disease after 2 or more prior lines of therapy OR
- Relapsed following autologous SCT,OR
- Ineligible for autologous SCT.
- Mantle cell lymphoma
- R/R disease as defined by disease progression after last regimen (including autologous SCT), OR Refractory disease as defined as failure to achieve a CR to last regimen.
- Prior therapy must include:
- Anthracycline or bendamustine-containing chemotherapy AND
- Anti-CD20 monoclonal antibody therapy AND
- BTKi therapy
- Chronic lymphocytic leukemia (CLL)
- CLL with an indication for treatment based on iwCLL guidelines and clinical measurable disease (lymphocytosis > 5×109/L and/or measurable lymph nodes and/or hepatic or splenomegaly)
- Subjects must have received previous treatment as follows:
- Subjects with high-risk features, defined as having complex cytogenetic abnormalities (3 or more chromosomal abnormalities), 17p deletion, TP53 mutation, or unmutated IGHV, must have failed at least 1 line of prior therapy, including a BTKi OR
- Subjects with standard-risk features must have failed at least 2 lines of prior therapy, including a BTKi OR
- Subjects who are BTKi intolerant and have received < 6 months of BTKi therapy, must have failed at least 1 high-risk line of non-BTKi therapy or 2 standard-risk lines of non-BTKi therapy OR
- Subjects who are ineligible for BTKi, must have failed at least 1 (high-risk) line of non-BTKi therapy or 2 (standard-risk) lines of non-BTKi therapy.
- Small lymphocytic lymphoma (SLL)
- SLL (lymphadenopathy) or SLL (splenomegaly and < 5x 109 CD19+ CD5+ clonal B lymphocytes/L [<5000/μL] in the peripheral blood at diagnosis with measurable disease defined as at least one lesion > 1/5 cm in the greatest transverse diameter that is biopsy-proven SLL)
- Subjects must have received previous treatments as follows:
- Subjects with high-risk features, defined as having complex cytogenetic abnormalities (3 or more chromosomal abnormalities), or 17p deletion, or TP53 mutation, or unmutated IGHV, must have failed at least 1 line of prior therapy, including a BTKi OR
- Subjects with standard-risk features must have failed at least 2 lines of prior therapy, including a BTKi OR
- Subjects who are BTKi intolerant and have received < 6 months of BTKi therapy must have failed at least 1 high-risk or 2 standard-risk other lines of non-BTKi therapy OR
- Subjects who are ineligible for BTKi, must have failed at least 1 high-risk or 2 standard-risk other lines of non-BTKi therapy.
- Mature T cell neoplasms:
- Peripheral T-Cell lymphoma (PTCL)/Cutaneous T-Cell Lymphoma (CTCL)
- R/R after 2 or more prior lines of therapy OR
- Relapse following autologous stem cell transplant OR
- T-cell prolymphocytic leukemia (TPLL) --- Diagnosis of TPLL with plan for subsequent therapy.
- Evidence of CD37 expression on tumor cells as demonstrated by flow cytometry and/or IHC on fresh biopsy or historic samples.
- Subjects must have measurable disease according to appropriate disease specific criteria.
- Adequate absolute lymphocyte count (ALC > 100 cells/ul) within one week of apheresis.
- Adequate bone marrow function defined by absolute neutrophil count (ANC) >1000 cells/mm3 without growth factor support (filgrastim within 7 days of pegfilgrastim within 14 days) and untransfused platelet count >50,000 mm3.
- Left ventricular ejection fraction > 40%
- Adequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) < 2.5 × upper limit of normal (ULN) and direct bilirubin < 1.5 × ULN.
- Adequate renal function defined by creatinine clearance >30 ml/min using the Cockcroft-Gault formula.
- The effects of CAR-37 T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis and until 6 months post CAR-37 infusion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 4 months after last CAR-37 T cells administration.
- Ability and willingness to adhere to the study visit schedule and all protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A).
- No Active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must be afebrile for 24 hours and blood cultures negative for 48 hours on appropriate antibiotic therapy.
- Oxygen saturation >92% on room air while awake.
- No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing.
Who cannot join
- Prior CD37 targeted therapies.
- Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.
- Any systemic anti-cancer therapy within 1 weeks of leukapheresis excluding steroids at or below physiologic dosing.
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.
- Ongoing systemic immunosuppression for acute and/or chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.
- Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and/or recent significant traumatic injury.
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- Active, uncontrolled, systemic bacterial, viral, or fungal infection.
- Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.
- Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.
- Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.
- Subjects with history of a new pulmonary embolism within 6 months of beginning lymphodepletion.
- Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
Official title: A Phase I Clinical Trial with CAR-37 T Cells for the Treatment of Patients with Relapsed or Refractory CD37+ Hematologic Malignancies
This research study is studying Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) for treating people with relapsed or refractory CD37+ hematologic malignancies and to understand the side effects when treated with CAR-37 T Cells.
- Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) is an investigational treatment
Read the detailed description
This is a two-part, non randomized, open label, single site Phase 1 study. Participants who fulfill eligibility criteria will be entered into the trial Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells).
This study consists of 2 parts:
- Part A (Dose Escalation): The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that have relapsed or refractory CD37+ hematologic malignancies, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated
- Part B (Expansion Cohort): Part B: Expansion Cohort: Participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Part A (Dose Escalation).
- A total of 18 participants will be enrolled to this trial
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.
Investigational" means that the intervention is being studied The U.S. Food and Drug Administration (FDA) has not approved CAR-37 T Cells as a treatment for any disease.
This is the first time that CAR-37 T Cells will be given to humans
- Conditions
- Hematologic Malignancy, Leukemia, Lymphoma, Lymphoma, B-Cell, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin
- Being tested
- CAR-37 T cells
- Keywords
- Leukemia, Hematologic Malignancy, Lymphoma, CAR-T
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Lymphoma, B-Cell, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-37 T cellsBiological
CAR-37 is an investigational treatment that uses the participant own immune cells, called T cells, to try to kill the cancerous cells
| Study group | Role | What they receive |
|---|---|---|
| CAR-37 T cells | Experimental | * CAR-37 will be administered intravenously on day 0
* Enrolled subjects will undergo a leukapheresis procedure processing approximately two times the subject's total blood volume.
* Subjects will receive 3 days of lymphodepleting chemotherapy starting Day -5, before the infusion of CAR-37 T cells on Day 0 Receives: Biological: CAR-37 T cells |
| CAR-37 T cells Dose Escalation | Experimental | * CAR-37 will be administered intravenously on day 0
* Enrolled subjects will undergo a leukapheresis procedure processing approximately two times the subject's total blood volume.
* CAR-37 will undergo dose escalation Receives: Biological: CAR-37 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: 2 years
The occurrence of study related adverse events
Measured: 2 years
Secondary outcomes (3)
Disease Specific Response
Measured: 2 years
Overall Survival
Measured: 2 years
Progression Free Survival
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start19 Jun 2020
- Primary completion30 Sep 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcela V. Maus, M.D.,Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcela V. Maus, M.D.,Ph.D., Massachusetts General Hospital
- Investigators
- Matthew J. Frigault, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136275
- Sponsor's protocol ID
- 19-087
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2019
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Publications
Scarfo I, Ormhoj M, Frigault MJ, Castano AP, Lorrey S, Bouffard AA, van Scoyk A, Rodig SJ, Shay AJ, Aster JC, Preffer FI, Weinstock DM, Maus MV. Anti-CD37 chimeric antigen receptor T cells are active against B- and T-cell lymphomas. Blood. 2018 Oct 4;132(14):1495-1506. doi: 10.1182/blood-2018-04-842708. Epub 2018 Aug 8.
PubMed 30089630Frigault MJ, Graham CE, Berger TR, Ritchey J, Horick NK, El-Jawahri A, Scarfo I, Schmidts A, Haradhvala NJ, Wehrli M, Lee WH, Parker AL, Wiggin HR, Bouffard A, Dey A, Leick MB, Katsis K, Elder EL, Dolaher MA, Cook DT, Chekmasova AA, Huang L, Nikiforow S, Daley H, Ritz J, Armant M, Preffer F, DiPersio JF, Nardi V, Chen YB, Gallagher KME, Maus MV. Phase 1 study of CAR-37 T cells in patients with relapsed or refractory CD37+ lymphoid malignancies. Blood. 2024 Sep 12;144(11):1153-1167. doi: 10.1182/blood.2024024104.
PubMed 38781564
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial with CAR-37 T Cells for the Treatment of Patients with Relapsed or Refractory CD37+ Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT04136275
- Acronym / sponsor ID
- 19-087
- Conditions
- Hematologic Malignancy, Leukemia, Lymphoma, Lymphoma, B-Cell, Lymphoma, T-Cell, Lymphoma, Non-Hodgkin
- Keywords
- Leukemia, Hematologic Malignancy, Lymphoma, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Marcela V. Maus, M.D.,Ph.D.University, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 23 Oct 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 research study is studying Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) for treating people with relapsed or refractory CD37+ hematologic malignancies and to understand the side effects when treated with CAR-37 T Cells.
- Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells) is an investigational treatment
Detailed description
This is a two-part, non randomized, open label, single site Phase 1 study. Participants who fulfill eligibility criteria will be entered into the trial Chimeric Antigen Receptor (CAR)-37 T Cells (CAR-37 T Cells).
This study consists of 2 parts:
- Part A (Dose Escalation): The investigators are looking the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects in participants that have relapsed or refractory CD37+ hematologic malignancies, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated
- Part B (Expansion Cohort): Part B: Expansion Cohort: Participants will be treated at the respective dose (at or below the Maximum Tolerated Dose), as determined during Part A (Dose Escalation).
- A total of 18 participants will be enrolled to this trial
This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.
Investigational" means that the intervention is being studied The U.S. Food and Drug Administration (FDA) has not approved CAR-37 T Cells as a treatment for any disease.
This is the first time that CAR-37 T Cells will be given to humans
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAR-37 T cells | Experimental | Biological: CAR-37 T cells* CAR-37 will be administered intravenously on day 0 * Enrolled subjects will undergo a leukapheresis procedure processing approximately two times the subject's total blood volume. * Subjects will receive 3 days of lymphodepleting chemotherapy starting Day -5, before the infusion of CAR-37 T cells on Day 0 |
| CAR-37 T cells Dose Escalation | Experimental | Biological: CAR-37 T cells* CAR-37 will be administered intravenously on day 0 * Enrolled subjects will undergo a leukapheresis procedure processing approximately two times the subject's total blood volume. * CAR-37 will undergo dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (53 listed)
- Voluntarily sign informed consent form.
- Age ≥18 years of at the time of signing informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Karnofsky ≥60%, see Appendix A)
- Diagnosis of relapsed/refractory (R/R) CD37+ hematologic malignancy as defined as one of the following:
- Mature B cell neoplasms
Key exclusion criteria (13 listed)
- Prior CD37 targeted therapies.
- Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.
- Any systemic anti-cancer therapy within 1 weeks of leukapheresis excluding steroids at or below physiologic dosing.
- Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.
- Ongoing systemic immunosuppression for acute and/or chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.
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 |
|---|---|---|
| CAR-37 T cellsCAR-37 is an investigational treatment that uses the participant own immune cells, called T cells, to try to kill the cancerous cells | Biological | CAR-37 T cells, CAR-37 T cells Dose Escalation |
Primary outcome
Dose Limiting Toxicity
Time frame: 2 years
The occurrence of study related adverse events
Time frame: 2 years
3 secondary outcomes
Disease Specific Response
Time frame: 2 years
Overall Survival
Time frame: 2 years
Progression Free Survival
Time frame: 2 Years
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 12 Dec 2024.
- Background: PubMed 30089630Scarfo I, Ormhoj M, Frigault MJ, Castano AP, Lorrey S, Bouffard AA, van Scoyk A, Rodig SJ, Shay AJ, Aster JC, Preffer FI, Weinstock DM, Maus MV. Anti-CD37 chimeric antigen receptor T cells are active against B- and T-cell lymphomas. Blood. 2018 Oct 4;132(14):1495-1506. doi: 10.1182/blood-2018-04-842708. Epub 2018 Aug 8.
- Derived from this study: PubMed 38781564Frigault MJ, Graham CE, Berger TR, Ritchey J, Horick NK, El-Jawahri A, Scarfo I, Schmidts A, Haradhvala NJ, Wehrli M, Lee WH, Parker AL, Wiggin HR, Bouffard A, Dey A, Leick MB, Katsis K, Elder EL, Dolaher MA, Cook DT, Chekmasova AA, Huang L, Nikiforow S, Daley H, Ritz J, Armant M, Preffer F, DiPersio JF, Nardi V, Chen YB, Gallagher KME, Maus MV. Phase 1 study of CAR-37 T cells in patients with relapsed or refractory CD37+ lymphoid malignancies. Blood. 2024 Sep 12;144(11):1153-1167. doi: 10.1182/blood.2024024104.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
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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.
Matthew J. Frigault, MD principal investigator
Massachusetts General Hospital
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 CAR-37 T cells in people with Hematologic Malignancy and Leukemia, run by Marcela V. Maus, M.D.,Ph.D. 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 53 inclusion and 13 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 12 Dec 2024. 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?
Dose Limiting Toxicity (time frame: 2 years). 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 NCT04136275, which also lists 2 linked publications.
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 12 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.