CD38 mAb Induction + Azathioprine Maintenance for Chronic Active AMR in Kidney Transplant Recipients (CAZA)
16 de julio de 2026 actualizado por: wujianyong
A Multicenter Exploratory Clinical Study of Targeted NK Cell Inhibition for Transplant Kidney Chronic Active Antibody-Mediated Rejection (caABMR): Single Induction With CD38 Monoclonal Antibody Followed by Sequential Maintenance With Azathioprine
This multicenter, prospective, single-arm exploratory study evaluates the efficacy and safety of a novel sequential regimen for chronic active antibody-mediated rejection (caABMR) in kidney transplant recipients: single-dose CD38 monoclonal antibody (1800 mg subcutaneous) induction to deplete plasma cells and NK cells, followed by long-term maintenance with azathioprine (replacing mycophenolate mofetil) plus standard triple immunosuppression (steroid + calcineurin inhibitor).
The regimen aims to control DSA-driven injury, stabilize or improve graft function (primary: eGFR decline slope), reduce DSA, improve pathology (Banff 2022), and minimize infection/nephrotoxicity risks associated with intensified or prolonged biologic therapy.
Twenty patients across 6 Chinese transplant centers will be enrolled.
CD38 mAb, azathioprine, key monitoring tests (HLA antibody, pharmacogenomics, immune profiling) are provided free by the study team (~40,000 RMB per patient).
Ethics approved; informed consent obtained.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: caABMR is the leading cause of late kidney allograft loss. Current therapies (plasmapheresis, IVIG, rituximab, bortezomib, long-term CD38 mAb) have limited efficacy, high recurrence, significant side effects, and high cost with no approved standard.
Rationale: CD38 mAb depletes antibody-producing plasma cells and pathogenic NK cells, rapidly lowering DSA and micro vascular inflammation. However, long-term monotherapy is costly and may increase infection risk. This study uses single induction dose + switch to azathioprine (safe, inexpensive, long-used in transplantation, suppresses NK activity) for durable, affordable maintenance. TPMT/NUDT15 genotyping guides personalized AZA dosing; serial NK cell monitoring targets <20/μL.
Design: Multicenter (6 centers), prospective, open-label, single-arm, exploratory (N=20).
Intervention: Baseline: CD38 mAb 1800 mg SC x1 + immediate switch MMF→AZA (dose per genotype: normal metabolizer 2-3 mg/kg/d; intermediate 0.6-2.4 mg/kg/d). Maintain triple IS (steroid + AZA + Tac target 5-7 ng/mL or CsA 150-250 ng/mL).
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Chunchun Wei, MD
- Número de teléfono: +8613738053172
- Correo electrónico: 327530957@qq.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Voluntary written informed consent.
- Age ≥18 years.
- Kidney transplant (living or deceased donor) ≥180 days prior.
- eGFR ≥30 mL/min/1.73 m² (CKD-EPI 2021).
- Currently on stable triple immunosuppression (CNI + MMF + steroid) for ≥4 weeks, no severe related adverse effects.
- Positive HLA Class I and/or Class II donor-specific antibodies (DSA).
- Transplant kidney biopsy meeting Banff 2022 criteria for chronic active antibody-mediated rejection (caABMR).
- TPMT/NUDT15 genotyping: non-homozygous mutant (normal or intermediate metabolizer).
Exclusion Criteria:
- Participating in another clinical trial.
- Age <18 years.
- Pregnant, breastfeeding, or inadequate contraception in females.
- ABO-incompatible transplant.
- TPMT/NUDT15 homozygous mutant genotype.
- Biopsy shows any of: T-cell mediated rejection (TCMR), new/recurrent severe thrombotic microangiopathy, or polyomavirus nephropathy.
- Received anti-rejection therapy in prior 3 months.
- Received other immunomodulatory monoclonal/polyclonal antibodies (anti-CD20, bortezomib, anti-C5, anti-IL-6/IL-6R) in prior 3 months.
- Total bilirubin >2×ULN or ALT/AST >2.5×ULN.
- Hemoglobin <8 g/dL.
- Platelets <100×10^9/L.
- WBC <3×10^9/L or neutrophils <1.5×10^9/L.
- Hypogammaglobulinemia: IgG <400 mg/dL.
- Active bacterial, viral, or fungal infection.
- Active malignancy requiring intensified immunosuppression.
- Latent or active tuberculosis.
- Live vaccine within 6 weeks of screening.
- History of alcohol or illicit drug abuse.
- Severe medical or psychiatric illness likely to impair study participation.
- Active hepatitis B.
- Known hypersensitivity to CD38 mAb, azathioprine, or study drug components, or severe drug allergy history.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental: CD38 mAb Induction + Azathioprine Sequential Maintenance
All enrolled caABMR patients receive:
|
Single 1800 mg subcutaneous injection at baseline to induce rapid depletion of plasma cells (source of DSA) and NK cells (key effectors of microvascular injury in caABMR).
Marketed anti-CD38 mAb (off-label use in this indication).
Otros nombres:
Oral azathioprine maintenance (replaces mycophenolate), individualized starting dose 2.0-3.0 mg/kg/day (normal TPMT/NUDT15 metabolizer) or 30-80% reduced (intermediate metabolizer), titrated per serial NK cell counts and hematologic tolerance.
Long-term NK suppression to maintain immune balance and protect graft.
Otros nombres:
Continued per local practice with protocol targets
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Slope of estimated glomerular filtration rate (eGFR) decline
Periodo de tiempo: Baseline through Week 28, planned assessments at weeks 0, 4, 8, 12, 16, 20, 24, 28
|
The primary efficacy endpoint is the slope of eGFR decline over 28 weeks, calculated from serial serum creatinine measurements (every 4 weeks) using the 2021 CKD-EPI equation.
Serum creatinine is measured by enzymatic method or isotope dilution mass spectrometry.
Slope is estimated via linear mixed-effects model or ordinary least-squares regression per patient, then summarized.
Negative slope indicates ongoing graft loss; less negative or positive slope indicates stabilization or improvement of renal function after treatment.
|
Baseline through Week 28, planned assessments at weeks 0, 4, 8, 12, 16, 20, 24, 28
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in peripheral blood NK cell, T cell and B cell subset counts and percentages measured by flow cytometry
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
|
Quantitative detection of lymphocyte subpopulations (NK, T, B cells) in peripheral blood via flow cytometry; evaluate the absolute count and relative percentage changes at each follow-up time point.
|
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
|
|
Absolute and relative percentage change in estimated glomerular filtration rate calculated by CKD-EPI 2021 formula
Periodo de tiempo: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
|
Estimated glomerular filtration rate (eGFR) is calculated by the CKD-EPI 2021 formula.
Both absolute value and relative percentage change of eGFR will be evaluated at all scheduled follow-up visits.
|
Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28
|
|
Percentage change in urine protein-to-creatinine ratio (UPCR)
Periodo de tiempo: Baseline and Week 28
|
Urine protein-to-creatinine ratio (UPCR) measured in mg/g or mg/mmol.
Urine protein is tested via pyrogallol red molybdate method, and creatinine is detected using sarcosine oxidase assay.
The relative percentage change of UPCR is used to evaluate renal therapeutic efficacy.
|
Baseline and Week 28
|
|
Relative percentage change in donor-specific antibody (DSA) mean fluorescence intensity (MFI)
Periodo de tiempo: Baseline, Week 8, Week 28
|
Donor-specific antibody MFI is detected via Luminex single-antigen bead assay.
Relative percentage change from baseline will be calculated to evaluate the reduction of alloantibody levels.
|
Baseline, Week 8, Week 28
|
|
Change in Transplant Kidney Biopsy Pathology Scores (Banff 2022)
Periodo de tiempo: Baseline, Week 28
|
Banff 2022 renal allograft pathology scoring system is applied for the interpretation of protocol kidney biopsy specimens.
The scores include microcirculation inflammation, tubulitis, interstitial inflammation, chronic glomerulopathy, transplant glomerulitis and chronic arteriopathy.
The pathological scores are recorded at screening baseline and week-28 follow-up biopsy.
The variation of each individual Banff lesion score between two time-points will be analyzed.
Higher Banff lesion scores represent more severe renal allograft injury.
|
Baseline, Week 28
|
|
Incidence of Acute Rejection (TCMR, AMR, or Mixed)
Periodo de tiempo: Through Week 28
|
Cumulative incidence (%) of biopsy-proven acute rejection, including T cell-mediated rejection (TCMR), antibody-mediated rejection (AMR), and mixed rejection, diagnosed according to Banff 2022 classification criteria.
|
Through Week 28
|
|
Patient overall survival rate
Periodo de tiempo: Week 28
|
The proportion of subjects who remain alive without all-cause mortality at the designated follow-up time point
|
Week 28
|
|
Graft survival rate
Periodo de tiempo: Week 28
|
Percentage of participants with functioning renal allograft, defined as no return to maintenance dialysis and no secondary kidney retransplantation
|
Week 28
|
|
Incidence of BK Virus (BKV) Infection
Periodo de tiempo: Through Week 28
|
Cases of BK virus infection are categorized as BKV viruria (>10³ copies/mL), BKV viremia (≥10⁴ copies/mL), or biopsy-confirmed BKV nephropathy identified by renal histology combined with SV40 IHC or ISH staining.
Cumulative incidence percentage will be calculated for each category.
|
Through Week 28
|
|
Incidence of Cytomegalovirus (CMV) Infection
Periodo de tiempo: Through Week 28
|
Cytomegalovirus infection is defined as detectable CMV DNA ≥10³ copies/mL quantified via quantitative PCR (qPCR).
Cumulative incidence percentage of affected subjects will be summarized.
|
Through Week 28
|
|
Incidence of Neutropenia
Periodo de tiempo: Through Week 28
|
Neutropenia is stratified by absolute neutrophil count (ANC): mild ANC <1.5×10⁹/L, moderate ANC <1.0×10⁹/L, severe ANC <0.5×10⁹/L.
Cumulative incidence percentage will be stratified by severity grades defined per NCI CTCAE or study protocol criteria.
|
Through Week 28
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Outcome Measure Title：Incidence of injection-related adverse reactions
Periodo de tiempo: Through Week 28
|
All infusion-related adverse events during the whole follow-up period will be recorded, including fever, chills, hypotension, dyspnea and other infusion-associated manifestations.
|
Through Week 28
|
|
Incidence of adverse events (AE) and serious adverse events (SAE)
Periodo de tiempo: Through Week 28
|
The type, severity, relation to study medication and occurrence frequency of all adverse events and serious adverse events will be collected, according to CTCAE common terminology criteria.
|
Through Week 28
|
|
Incidence of liver function abnormalities
Periodo de tiempo: Through Week 28
|
Liver function indexes including alanine transaminase, aspartate transaminase, total bilirubin will be tested regularly.
Liver function abnormality is defined as laboratory elevation exceeding 3-fold upper limit of normal range.
|
Through Week 28
|
|
Incidence of all-cause hospitalization
Periodo de tiempo: Through Week 28
|
All hospitalization events for any reason during follow-up will be documented, including the admission time, diagnosis and length of hospital stay.
|
Through Week 28
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jianyong Wu, MD, Zhejiang University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Lokhorst HM, Plesner T, Laubach JP, Nahi H, Gimsing P, Hansson M, Minnema MC, Lassen U, Krejcik J, Palumbo A, van de Donk NW, Ahmadi T, Khan I, Uhlar CM, Wang J, Sasser AK, Losic N, Lisby S, Basse L, Brun N, Richardson PG. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma. N Engl J Med. 2015 Sep 24;373(13):1207-19. doi: 10.1056/NEJMoa1506348. Epub 2015 Aug 26.
- ten Berge RJ, Schellekens PT, Surachno S, The TH, ten Veen JH, Wilmink JM. A longitudinal study on the effects of azathioprine and high doses of prednisone on the immune system of kidney-transplant recipients. Clin Immunol Immunopathol. 1982 Jul;24(1):33-46. doi: 10.1016/0090-1229(82)90086-1. No abstract available.
- Hoffmann U, Neudorfl C, Daemen K, Keil J, Stevanovic-Meyer M, Lehner F, Haller H, Blume C, Falk CS. NK Cells of Kidney Transplant Recipients Display an Activated Phenotype that Is Influenced by Immunosuppression and Pathological Staging. PLoS One. 2015 Jul 6;10(7):e0132484. doi: 10.1371/journal.pone.0132484. eCollection 2015.
- Prince HE, Ettenger RB, Dorey FJ, Fine RN, Fahey JL. Azathioprine suppression of natural killer activity and antibody-dependent cellular cytotoxicity in renal transplant recipients. Transplant Proc. 1984 Dec;16(6):1475-7. No abstract available.
- Reinders ME, Hoogduijn MJ. NK Cells and MSCs: Possible Implications for MSC Therapy in Renal Transplantation. J Stem Cell Res Ther. 2014 Feb 7;4(2):1000166. doi: 10.4172/2157-7633.1000166. No abstract available.
- Chambon M, Koenig A. NK Cells: Not Just Followers But Also Initiators of Chronic Vascular Rejection. Transpl Int. 2024 Oct 16;37:13318. doi: 10.3389/ti.2024.13318. eCollection 2024.
- Chocair PR, Neves PDMM, Mohrbacher S, Neto MP, Sato VAH, Oliveira ES, Barbosa LV, Bales AM, da Silva FP, Cuvello-Neto AL, Duley JA. Case Report: Azathioprine: An Old and Wronged Immunosuppressant. Front Immunol. 2022 Jun 10;13:903012. doi: 10.3389/fimmu.2022.903012. eCollection 2022.
- Bohmig GA, Naesens M, Viklicky O, Thaunat O, Diebold M, Rostaing L, Budde K. Antibody-mediated rejection-treatment standard. Nephrol Dial Transplant. 2025 Aug 1;40(8):1615-1627. doi: 10.1093/ndt/gfaf097.
- Matignon M, Grimbert P, Moktefi A, Pilon C. Anti-CD38 and Regression of Chronic Active Antibody-Mediated Rejection After Kidney Transplantation - Myth or Reality? Kidney Int Rep. 2025 Sep 2;10(10):3305-3307. doi: 10.1016/j.ekir.2025.08.031. eCollection 2025 Oct. No abstract available.
- Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025.
- Etieve R, Van Wynsberghe M, Grange S, Laurent C, Lemoine M, Candon S, Bertrand D, de Nattes T. One tool, multiple gains: anti-CD38 therapy in antibody-mediated rejection. Clin Kidney J. 2025 Sep 11;18(Suppl 2):ii55-ii64. doi: 10.1093/ckj/sfaf283. eCollection 2025 Dec.
- Mayer KA, Schrezenmeier E, Diebold M, Halloran PF, Schatzl M, Schranz S, Haindl S, Kasbohm S, Kainz A, Eskandary F, Doberer K, Patel UD, Dudani JS, Regele H, Kozakowski N, Klager J, Boxhammer R, Amann K, Puchhammer-Stockl E, Vietzen H, Beck J, Schutz E, Akifova A, Firbas C, Gilbert HN, Osmanodja B, Halleck F, Jilma B, Budde K, Bohmig GA. A Randomized Phase 2 Trial of Felzartamab in Antibody-Mediated Rejection. N Engl J Med. 2024 Jul 11;391(2):122-132. doi: 10.1056/NEJMoa2400763. Epub 2024 May 25.
- Kwun J, Matignon M, Manook M, Guendouz S, Audard V, Kheav D, Poullot E, Gautreau C, Ezekian B, Bodez D, Damy T, Faivre L, Menouche D, Yoon J, Park J, Belhadj K, Chen D, Bilewski AM, Yi JS, Collins B, Stegall M, Farris AB, Knechtle S, Grimbert P. Daratumumab in Sensitized Kidney Transplantation: Potentials and Limitations of Experimental and Clinical Use. J Am Soc Nephrol. 2019 Jul;30(7):1206-1219. doi: 10.1681/ASN.2018121254. Epub 2019 Jun 21.
- Yang D, Agrawal N, Marcus C, Roy N, Richards KR, Nahas MR, Cardarelli F. Treatment of Multiple Myeloma With Daratumumab in a Kidney Transplant Patient. Am J Ther. 2021 Jul-Aug 01;28(4):e488-e491. doi: 10.1097/MJT.0000000000001024.
- Lye WC, Loh HL. Anti-CD38 Daratumumab Treatment of Chronic Active Antibody-Mediated Kidney Allograft Rejection. Kidney Int Rep. 2025 Jul 15;10(10):3506-3515. doi: 10.1016/j.ekir.2025.07.009. eCollection 2025 Oct.
- Milani P, Basset M, Curci P, Foli A, Rizzi R, Nuvolone M, Guido R, Gesualdo L, Specchia G, Merlini G, Palladini G. Daratumumab in light chain deposition disease: rapid and profound hematologic response preserves kidney function. Blood Adv. 2020 Apr 14;4(7):1321-1324. doi: 10.1182/bloodadvances.2020001553.
- Koenig A, Mezaache S, Callemeyn J, Barba T, Mathias V, Sicard A, Charreau B, Rabeyrin M, Dijoud F, Picard C, Meas-Yedid V, Olivo-Marin JC, Morelon E, Naesens M, Dubois V, Thaunat O. Missing Self-Induced Activation of NK Cells Combines with Non-Complement-Fixing Donor-Specific Antibodies to Accelerate Kidney Transplant Loss in Chronic Antibody-Mediated Rejection. J Am Soc Nephrol. 2021 Feb;32(2):479-494. doi: 10.1681/ASN.2020040433. Epub 2020 Nov 25.
- Jain D, Rajab A, Young JS, Yin D, Nadasdy T, Chong AS, Pelletier RP. Reversing donor-specific antibody responses and antibody-mediated rejection with bortezomib and belatacept in mice and kidney transplant recipients. Am J Transplant. 2020 Oct;20(10):2675-2685. doi: 10.1111/ajt.15881. Epub 2020 Apr 28.
- Ishida H, Unagami K, Omoto K, Kanzawa T, Tanabe K. Desensitization Regimen Consisting of High-Dose Intravenous Immunoglobulin, Plasmapheresis, and Rituximab (an Anti-CD20 Antibody), Without Eculizumab and/or Bortezomib, in 41 Highly Sensitized Kidney Transplant Recipients. Exp Clin Transplant. 2021 Oct;19(10):1032-1040. doi: 10.6002/ect.2021.0234. Epub 2021 Sep 8.
- Ardissino G, Cresseri D, Tel F, Giussani A, Salardi S, Sgarbanti M, Strumbo B, Testa S, Capone V, Griffini S, Grovetti E, Cugno M, Belingheri M, Tamburello C, Rodrigues EM, Perrone M, Cardillo M, Corti G, Consonni D, Furian L, Tedeschi S, Messa P, Beretta C. Kidney transplant in patients with atypical hemolytic uremic syndrome in the anti-C5 era: single-center experience with tailored Eculizumab. J Nephrol. 2021 Dec;34(6):2027-2036. doi: 10.1007/s40620-021-01045-7. Epub 2021 May 6.
- Doberer K, Duerr M, Halloran PF, Eskandary F, Budde K, Regele H, Reeve J, Borski A, Kozakowski N, Reindl-Schwaighofer R, Waiser J, Lachmann N, Schranz S, Firbas C, Muhlbacher J, Gelbenegger G, Perkmann T, Wahrmann M, Kainz A, Ristl R, Halleck F, Bond G, Chong E, Jilma B, Bohmig GA. A Randomized Clinical Trial of Anti-IL-6 Antibody Clazakizumab in Late Antibody-Mediated Kidney Transplant Rejection. J Am Soc Nephrol. 2021 Mar;32(3):708-722. doi: 10.1681/ASN.2020071106. Epub 2020 Dec 18.
- Caliskan Y, Mirioglu S, Dirim AB, Ozluk Y, Yegit O, Aksoy E, Safak S, Guller N, Demir E, Artan AS, Oto OA, Besisik S, Yazici H, Turkmen A, Lentine KL. A comparison of methods of plasmapheresis for the treatment of late antibody mediated rejection in kidney transplant recipients. Ther Apher Dial. 2023 Jun;27(3):428-434. doi: 10.1111/1744-9987.13937. Epub 2022 Oct 14.
- Aziz F, Parajuli S, Jorgenson M, Garg N, Manchala V, Yousif E, Mandelbrot D, Hidalgo L, Mohamed M, Zhong W, Djamali A. Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients: Treatment Response Rates and Value of Early Surveillance Biopsies. Transplant Direct. 2022 Aug 4;8(9):e1360. doi: 10.1097/TXD.0000000000001360. eCollection 2022 Sep.
- Pelletier K, Cote G, Madsen K, Chen S, Kim SJ, Chan CT, Mattsson J, Pasic I, Kitchlu A. Chronic kidney disease, survival and graft-versus-host-disease-free/relapse-free survival in recipients of allogeneic hematopoietic stem cell transplant. Clin Kidney J. 2022 Apr 7;15(8):1583-1592. doi: 10.1093/ckj/sfac091. eCollection 2022 Aug.
- Maghen A, Mone TD, Veale J. The Kidney-Transplant Waiting List and the Opioid Crisis. N Engl J Med. 2019 Jun 6;380(23):2273-2274. doi: 10.1056/NEJMc1817188. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de julio de 2026
Finalización primaria (Estimado)
15 de marzo de 2028
Finalización del estudio (Estimado)
15 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
11 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de julio de 2026
Publicado por primera vez (Actual)
21 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIT20260074C-R1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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Ensayos clínicos sobre CD38
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