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Multiple MyelomaEarly Phase 1NCT07727668

Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior to Leukapheresis for Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Relapsed/Refractory Multiple Myeloma (RRMM)

A Early Phase 1 study testing Iberdomide, CAR-T Leukapheresis and CAR-T Infusion in people with Multiple Myeloma and Relapsed/Refractory Multiple Myeloma, run by Shambavi Richard at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This feasibility trial studies the efficacy of administering iberdomide (CC-220) as a priming agent prior to leukapheresis in patients with relapsed/refractory multiple myeloma (RRMM) who are already planned for standard-of-care CAR-T therapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Iberdomide, CAR-T Leukapheresis and CAR-T Infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Jul 2026to Jul 2031
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • Subject is ≥18 years of age at the time of signing the informed consent form (ICF).
  • Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
  • All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with either cilta-cel or ide-cel.
  • All subjects must have ≥2 prior lines of multiple myeloma directed therapy, as determined by their treating clinician
  • All patients must have ECOG Performance Status ≤ 2.
Show all 12Show fewer
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy tests (minimum sensitivity 25 IU/L or equivalent units of hCG), at screening (10-14 days prior to start of study drug); another within 24 hours prior to the start of study drug.
  • Women must not be breastfeeding
  • WOCBP must agree to follow instructions for method(s) of contraception for 1 month (4 weeks) before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 1 month (4 weeks) after completion of iberdomide.
  • Males who are sexually active with WOCBP must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Iberdomide (CC-220) and for up to 90 days after discontinuing Iberdomide (CC-220), even if they have undergone a successful vasectomy. Male patients must not donate sperm.
  • Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.
  • All subjects must agree not to share study medication.

Who cannot join

  • Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Subjects with active plasma cell leukemia (defined as either 20% of peripheral blood white blood cell count comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 109/L)
  • Subjects with active Central Nervous System involvement with multiple myeloma
  • Subjects with active multiple myeloma that cannot be safely managed with single-agent iberdomide for the duration of the priming period, per the discretion of the treating physician or PI
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
  • Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk, per the discretion of the treating physician or PI
Show all 37Show fewer
  • Subjects with an active infection that requires parenteral anti-infective treatment within 7 days
  • Unable to tolerate thromboembolic prophylaxis while on iberdomide
  • Severe hypersensitivity reaction to prior IMiD (thalidomide, lenalidomide or pomalidomide)
  • Grade > 2 peripheral neuropathy (per NCI CTCAE v5.0)
  • Patients with a positive PCR test for hepatitis B virus or hepatitis C virus indicating active infection. Patients with positive serologic testing indicating exposure will need confirmatory testing by PCR.
  • Patients with detectable HIV viral load or known acquired immunodeficiency syndrome (AIDS).
  • Prior or concurrent malignancy, except for the following:
  • Adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma.
  • Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.
  • Localized prostate cancer (N0M0):
  • with a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance,
  • with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence; or
  • any history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence per the discretion of the treating physician or PI
  • Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.
  • Breast cancer: adequately treated lobular carcinoma in situ, or ductal carcinoma in situ, or history of localized breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence.
  • Any other cancer from which the subject has been disease free for > 3 years prior to study entry, or considered cured with minimal risk of disease recurrence.
  • Prior treatment with Iberdomide (CC-220) within 6 months prior to enrollment
  • Prior allogeneic stem cell transplant except subjects who have completed the stem cell transplant > 12 months prior to first dose of study drug, have no history of graft versus host disease, and are not on systemic immunosuppressive therapy
  • Major cardiac surgery within 8 weeks prior to the first dose of study drug; all other major surgery within 4 weeks prior to the first dose of study drug.
  • Subjects with following physical and laboratory test findings:
  • Absolute neutrophil count < 1 x 109/L without growth factor support within 1 week, or absolute neutrophil count < 0.5 x 109/L for patients with documented Duffy-null blood typing
  • Platelets < 50 x 109/L without transfusion support within 1 week
  • Creatinine clearance < 30 ml/min according to the Cockroft-Gault formula:
  • Female CrCl = [(140 - age in years) x weight in kg x 0.85] / [72 x serum creatinine in mg/dl]
  • Male CrCl = [(140 - age in years) x weight in kg x 1.00] / [72 x serum creatinine in mg/dl]
  • Total bilirubin ≥ 2 x ULN (≥ 3 x ULN if documented Gilbert's syndrome)
  • AST or ALT ≥ 3x ULN
  • Corrected serum calcium > 13.5 mg/dL
  • Are also excluded:
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vikram Madan, MPH contact

(347) 835-3446

vikram.madan@mssm.edu

Rashmi Unawane contact

(212) 824-2385

rashmi.unawane@mssm.edu

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Vikram Madan, (646) 745-6092, Vikram.Madan@mssm.edu

    Rashmi Unawane, 212-824-2385, Rashmi.Unawane@mssm.edu

Other trials in United States

About this study

Official title: Feasibility Study of Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior to Leukapheresis for Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Relapsed/Refractory Multiple Myeloma (RRMM)

This feasibility trial studies the efficacy of administering iberdomide (CC-220) as a priming agent prior to leukapheresis in patients with relapsed/refractory multiple myeloma (RRMM) who are already planned for standard-of-care CAR-T therapy. Giving iberdomide before CAR-T may improve T cell fitness which may improve CAR-T expansion kinetics and response after infusion.

Read the detailed description

In this feasibility study, patients with RRMM planned for standard of care CAR-T will be approached for consent for enrollment. Participating patients will receive one 28-day cycle of iberdomide at a dose of 1.0 mg daily, using a dosing schedule of 1.0 mg once daily for 21 days followed by 7 days off. After completion of the 28-day cycle, patients will proceed with leukapheresis on day 29 of therapy, with allowance for up to a 14-day delay in leukapheresis if needed. Blood samples will be collected on day 1 (prior to iberdomide exposure) and on the day of leukapheresis to compare T cell profiling before and after iberdomide priming. After leukapheresis, patients will proceed with standard of care management, including bridging therapy if indicated, until CAR-T infusion. After infusion, blood samples will be collected daily during initial hospitalization, then weekly for 1 month, and then monthly for up to 1 year. Blood samples will be evaluated for maximal CAR-T and ALC expansion and CAR-T persistence. Patients will be monitored per standard of care protocols for clinical efficacy and toxicity after CAR-T therapy for up to 1 year.

Being tested
Iberdomide, CAR-T Leukapheresis, CAR-T Infusion
Keywords
Multiple myeloma, Relapsed/refractory multiple myeloma, Iberdomide, CAR-T therapy, CC-220
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IberdomideDrug

    Also called CC-220

    1.0mg iberdomide capsules administered orally, daily on days 1-21 of a 28-day cycle

  • CAR-T LeukapheresisProcedure or surgery

    A procedure in which blood is collected and white blood cells (including T cells) are separated and collected. The remaining blood components are returned to the participant. The collected T cells will be used to manufacture the CAR-T cell therapy.

  • CAR-T InfusionProcedure or surgery

    Participants will receive an intravenous infusion of standard-of-care CAR-T therapy manufactured from the participant's previously collected cells

Study groups in NCT07727668
Study groupRoleWhat they receive
Patients with RRMMExperimentalPatients with RRMM who are already planned for standard-of-care CAR-T therapy. Study participants will be planned for one cycle (28 days) of iberdomide therapy (1.0mg daily on days 1-21 of a 28-day cycle), followed by CAR-T leukapheresis. Patients will then proceed with CAR-T infusion per standard of care, with additional lab monitoring for T cell phenotyping and CAR-T expansion kinetics.
Receives: Drug: Iberdomide; Procedure: CAR-T Leukapheresis; Procedure: CAR-T Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming.

    Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming, defined as an absolute increase of >10 percentage points or a relative increase of >50% in TEM cells.

    Measured: On the day of leukapheresis, after completing iberdomide therapy on Day 29

Secondary outcomes (14)

  1. Change in Proportion of T cell subsets from baseline after iberdomide priming

    Proportion of T cell subsets (including terminally differentiated effector, exhausted, and activated T cells) present for each participant in the feasibility evaluable (FE) population at leukapheresis (Priming D29 after iberdomide) to baseline (Priming-D1).

    Measured: On the day of leukapheresis, after completing iberdomide therapy on Day 29

  2. Cmax with iberdomide priming prior to leukapheresis

    Cmax is the highest measured concentration of iberdomide. Cmax will be assessed in the CAR-T evaluable (CARTE) population

    Measured: After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

  3. Tmax with iberdomide priming prior to leukapheresis,

    Time to reach Cmax. Tmax will be assessed in CAR-T (CARTE) population

    Measured: After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

  4. AUC0-14 with iberdomide priming prior to leukapheresis

    Total Exposure over time. AUC0-14 will be assessed in the CAR-T evaluable (CARTE) population.

    Measured: After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

  5. CAR-T persistence with iberdomide priming prior to leukapheresis,

    CAR-T persistence will track therapy effectiveness over time. CAR-T persistence will be assessed in the CAR-T evaluable (CARTE) population.

    Measured: After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

  6. ALCmax with iberdomide priming prior to leukapheresis

    Absolute Lymphocyte Count (ALC) is a key blood test measuring the exact number of lymphocytes. ALCmax measures the maximum count overtime. ALCmax will be assessed in the CAR-T evaluable (CARTE) population.

    Measured: After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

  7. Time to ALCmax with iberdomide priming prior to leukapheresis

    Time to reach absolute lymphocyte count maximum (ALCmax) in the CAR-T evaluable (CARTE) population.

    Measured: After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

  8. Absolute lymphocyte count (ALC) expansion kinetics as a proxy for CAR-T expansion

    Measured: After CAR-T infusion at Day 14, Day 28, Month 3, Month 6, Month 12

  9. Overall response rate

    Overall response rate (ORR), defined as the proportion of patients that achieve at least a partial response according to IMWG criteria

    Measured: After CAR-T at Day 100 (~Month 3) and Month 12

  10. Measurable residual disease

    Rate of measurable residual disease (MRD)-negativity and MRD-negative complete response (CR) as defined by IMWG response criteria

    Measured: After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.

  11. Progression-free survival

    Progression-free survival (PFS), defined as the time from CAR-T infusion until progression by IMWG response criteria or death

    Measured: After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.

  12. Overall survival

    Overall survival (OS), defined as the time from CAR-T infusion until death

    Measured: After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.

  13. Duration of response

    Duration of response (DOR), defined as time from first observed response after CAR-T until progression by IMWG criteria

    Measured: After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.

  14. Time to next treatment

    Time to next treatment (TTNT), defined as the time from CAR-T infusion until initiation of the next line of myeloma-directed therapy for subsequent relapsed disease

    Measured: After CAR-T at Day 100 (~Month 3) and Month 12. Long-term follow-up for up to 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07727668
Sponsor's protocol ID
Study-26-00586
Status last verified
Jul 2026
First submitted
16 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The completed dataset is the sole property of the Sponsor-Investigator's institution and should not be exported to third parties, except for authorized representatives of appropriate Health/Regulatory Authorities, without permission from the Sponsor-investigator and their institution.

Publications

  • Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.

    PubMed 30592986

  • Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.

    PubMed 27511158

  • Kumar SK, Rajkumar V, Kyle RA, van Duin M, Sonneveld P, Mateos MV, Gay F, Anderson KC. Multiple myeloma. Nat Rev Dis Primers. 2017 Jul 20;3:17046. doi: 10.1038/nrdp.2017.46.

    PubMed 28726797

  • Rajkumar SV. Multiple myeloma: 2024 update on diagnosis, risk-stratification, and management. Am J Hematol. 2024 Sep;99(9):1802-1824. doi: 10.1002/ajh.27422. Epub 2024 Jun 28.

    PubMed 38943315

  • Rajkumar SV, Kumar S. Multiple myeloma current treatment algorithms. Blood Cancer J. 2020 Sep 28;10(9):94. doi: 10.1038/s41408-020-00359-2.

    PubMed 32989217

  • D'Agostino M, Raje N. Anti-BCMA CAR T-cell therapy in multiple myeloma: can we do better? Leukemia. 2020 Jan;34(1):21-34. doi: 10.1038/s41375-019-0669-4. Epub 2019 Nov 28.

    PubMed 31780814

  • Kryukova EV, Vulfius CA, Ziganshin RH, Andreeva TV, Starkov VG, Tsetlin VI, Utkin YN. Snake C-type lectin-like proteins inhibit nicotinic acetylcholine receptors. J Venom Res. 2020 Jul 6;10:23-29. eCollection 2020.

    PubMed 33024544

  • Sommermeyer D, Hudecek M, Kosasih PL, Gogishvili T, Maloney DG, Turtle CJ, Riddell SR. Chimeric antigen receptor-modified T cells derived from defined CD8+ and CD4+ subsets confer superior antitumor reactivity in vivo. Leukemia. 2016 Feb;30(2):492-500. doi: 10.1038/leu.2015.247. Epub 2015 Sep 15.

    PubMed 26369987

  • Cohen AD, Garfall AL, Stadtmauer EA, Melenhorst JJ, Lacey SF, Lancaster E, Vogl DT, Weiss BM, Dengel K, Nelson A, Plesa G, Chen F, Davis MM, Hwang WT, Young RM, Brogdon JL, Isaacs R, Pruteanu-Malinici I, Siegel DL, Levine BL, June CH, Milone MC. B cell maturation antigen-specific CAR T cells are clinically active in multiple myeloma. J Clin Invest. 2019 Mar 21;129(6):2210-2221. doi: 10.1172/JCI126397.

    PubMed 30896447

  • Okkabaz N, Turgut MA. Necrotising fasciitis of the thigh caused by duodenum invasion of renal cell carcinoma: A case report. Int Wound J. 2019 Oct;16(5):1195-1198. doi: 10.1111/iwj.13186. Epub 2019 Aug 12.

    PubMed 31407501

  • Fischer L, Grieb N, Born P, Weiss R, Seiffert S, Boldt A, Fricke S, Franz P, Heyn S, Kubasch AS, Baber R, Weidner H, Wang SY, Bach E, Hoffmann S, Ussmann J, Kirchberg J, Hell S, Schwind S, Metzeler KH, Herling M, Jentzsch M, Franke GN, Sack U, Reiche K, Kohl U, Platzbecker U, Vucinic V, Merz M. Cellular dynamics following CAR T cell therapy are associated with response and toxicity in relapsed/refractory myeloma. Leukemia. 2024 Feb;38(2):372-382. doi: 10.1038/s41375-023-02129-y. Epub 2024 Jan 6.

    PubMed 38184754

  • Doting EL, Jensen MB, Peter EK, Ellegaard-Jensen L, Tranter M, Benning LG, Hansen M, Anesio AM. The exometabolome of microbial communities inhabiting bare ice surfaces on the southern Greenland Ice Sheet. Environ Microbiol. 2024 Feb;26(2):e16574. doi: 10.1111/1462-2920.16574. Epub 2024 Jan 23.

    PubMed 38263628

  • Lin Y, Raje NS, Berdeja JG, Siegel DS, Jagannath S, Madduri D, Liedtke M, Rosenblatt J, Maus MV, Massaro M, Petrocca F, Yeri A, Finney O, Caia A, Yang Z, Martin N, Campbell TB, Rytlewski J, Fuller J, Hege K, Munshi NC, Kochenderfer JN. Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial. Nat Med. 2023 Sep;29(9):2286-2294. doi: 10.1038/s41591-023-02496-0. Epub 2023 Aug 17.

    PubMed 37592106

  • Tricarico PM, Zupin L, Ottaviani G, Rupel K, Celsi F, Genovese G, Boniotto M, Crovella S, Marzano AV. Photobiomodulation as potential novel third line tool for non-invasive treatment of hidradenitis suppurativa. G Ital Dermatol Venereol. 2020 Feb;155(1):88-98. doi: 10.23736/S0392-0488.19.06247-3. Epub 2019 Apr 23.

    PubMed 31042851

  • Calderon-Ruiz P, Haist G, Mascus A, Holguin-Rocha AF, Koliopoulos P, Daniel T, Velez G, Londono-Renteria B, Grondahl B, Tobon-Castano A, Gehring S. Multiplex Reverse Transcription Polymerase Chain Reaction Combined with a Microwell Hybridization Assay Screening for Arbovirus and Parasitic Infections in Febrile Patients Living in Endemic Regions of Colombia. Trop Med Infect Dis. 2023 Oct 6;8(10):466. doi: 10.3390/tropicalmed8100466.

    PubMed 37888594

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Iberdomide, CAR-T Leukapheresis and CAR-T Infusion in people with Multiple Myeloma and Relapsed/Refractory Multiple Myeloma, run by Shambavi Richard 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 12 inclusion and 37 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: opening soon, as of the sponsor's last update on 27 Jul 2026. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vikram Madan, MPH ((347) 835-3446, vikram.madan@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with T cell effector memory (TEM) expansion following iberdomide priming. (time frame: On the day of leukapheresis, after completing iberdomide therapy on Day 29). 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 NCT07727668, which also lists 30 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 27 Jul 2026.

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