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Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors, Immunomodulators and Anti-CD38 Antibody.

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ClinicalTrials.gov Identifier: NCT04309981
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : February 4, 2022
Sponsor:
Collaborators:
Fondos ARI (Assistencia Recerca Intensiva)
Instituto de Salud Carlos III
Fondo Social La Caixa
Information provided by (Responsible Party):
Sara V. Latorre, Institut d'Investigacions Biomèdiques August Pi i Sunyer

Brief Summary:
To assess the safety and efficacy of CARTBCMA ARI0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Biological: Adult differentiated autologous T-cells with anti-BCMA specificity Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-BCMA (TNFRSF17) Specificity Humanized Conjugated With the Co-stimulatory Region 4-1BB and Signal-transduction CD3z (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma With Previous Treatment With Proteasome Inhibitor, Immunomodulatory Drug and Anti-CD38 Monoclonal Antibody
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: ARI0002h
Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity conjugated to the 4-1BB co-stimulatory region and signal-transduction CD3z that has been humanized
Biological: Adult differentiated autologous T-cells with anti-BCMA specificity
After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-BCMA specificity will be transfused.
Other Name: CARTBCMA




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 3 months ]
  2. Cytokine release syndrome rate [ Time Frame: within 30 days of first infusion ]

Secondary Outcome Measures :
  1. Duration of the response [ Time Frame: up to 36 months after treatment ]
  2. Response rate [ Time Frame: over the first year ]
  3. Complete response rate (CR) [ Time Frame: at month 3 and month 6 of first infusion ]
  4. Overall response rate (ORR) [ Time Frame: at month 6 of first infusion ]
  5. Time to complete response [ Time Frame: up to 36 months after treatment ]
  6. Response rate of extramedullary disease by PET-CT [ Time Frame: up to 36 months after treatment ]
  7. Negative MRD rate in bone marrow [ Time Frame: at month 3 and month 6 of first infusion ]
  8. Response rate of extramedullary disease by PET-TC [ Time Frame: at month 3 ]
  9. Progression free survival (PFS) [ Time Frame: at month 12, and up to 36 months after treatment ]
  10. Overall survival (OS) defined as the time elapsed between the infusion of ARI0002h and the death of the patient from any cause [ Time Frame: up to 36 months after treatment ]
  11. Presence of tumor lysis syndrome [ Time Frame: up to 36 months after treatment ]
  12. Presence of cytokine release syndrome [ Time Frame: up to 36 months after treatment ]
  13. Presence of neurological toxicity [ Time Frame: up to 36 months after treatment ]
  14. Presence of prolonged cytopenia [ Time Frame: up to 36 months after treatment ]
  15. Persistence of CART BCMA ARI0002 in peripheral blood [ Time Frame: month 1, 2, 3, 4, 5, 6 and every 6 months until 2 years of follow up ]
  16. Expression of BCMA [ Time Frame: at screening, at day +28, at day +100, at month 6, 12, 18 and 24 ]
  17. Levels of soluble BCMA in serum [ Time Frame: at screening, at day 0, +3, +7,+14,+28, +70 +100, at month 4, 5, 6, 7, 8, 9, 1,11, 12, 18 and 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients between the age of 18 and 75 years with diagnosis of multiple myeloma
  • Disease measurable by monoclonal component in serum and/or urine or by free light chains in serum according to the eligibility criteria for clinical trials of the International Myeloma Working Group
  • Previous two or more lines of treatment. Patients must have received at least a proteasome inhibitor (such as bortezomib or carfilzomib), an immunomodulatory drug (lenalidomide or pomalidomide) and an anti-CD38 monoclonal antibody (such as daratumumab)
  • Refractory to the last line of treatment
  • ECOG functional status ranging from 0 to 2
  • Life expectancy over 3 months
  • Patients who, after being informed, give their consent by signing the Informed Consent document.

Exclusion Criteria:

  • Previous allogeneic transplant in the prior 6 months to inclusion or GVHD that requires active systemic immunosuppressive treatment
  • Absolute lymphocyte count <0.1x10^9/ L
  • Previous neoplasia, except if patients have been in complete remission > 3 years, except for cutaneous carcinoma (non-melanoma)
  • Active infection that requires treatment
  • Active infection by HIV, HBV or HCV.
  • Uncontrolled medical disease
  • Severe organic condition that meets any of the following criteria: EF <40%, DLCO <40%, EGFR <50 ml / min, bilirubin> 3 times normal value (except Gilbert syndrome)
  • Previous diagnosis of symptomatic AL amyloidosis
  • Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test in the screening phase
  • Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who cannot or do not wish to use highly effective contraceptive methods from the beginning until the end of the study.
  • Men who cannot or do not wish to use highly effective contraceptive methods from the beginning to the end of the study.
  • Contraindication to receive conditioning chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309981


Contacts
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Contact: Carlos Fernandez de Larrea, MD, PhD +34932245400 cfernan1@clinic.cat
Contact: Sara Varea, BSc +34932245400 svarea@clinic.cat

Locations
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Spain
Hospital U. de Santiago de Compostela Not yet recruiting
Santiago De Compostela, A Coruña, Spain, 15706
Contact: Marta S González Pérez         
Principal Investigator: Marta s González Pérez         
Clinica Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Paula Rodríguez Otero, MD, PhD       paurodriguez@unav.es   
Principal Investigator: Paula Rodríguez Otero         
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Carlos Fernandez de Larrea, MD PhD    +34932275400    cfernan1@clinic.cat   
Principal Investigator: Carlos Fernandez de Larrea, MD PhD         
Hospital 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Joaquín Martínez         
Principal Investigator: Joaquín Martínez         
Hospital Clínico Universitario Virgen de La Arrixaca Recruiting
Murcia, Spain, 30120
Contact: Jose M Moraleda, MD PhD       jmoraled@um.es   
Principal Investigator: Jose M Moraleda         
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Contact: Maria V Mateos, MD, PhD       mvmateos@usal.es   
Principal Investigator: Maria V Mateos         
Hospital Universitario Virgen Del Rocío Recruiting
Sevilla, Spain, 41013
Contact: Juan L Reguera Ortega         
Principal Investigator: Juan L Reguera Ortega         
Sponsors and Collaborators
Sara V. Latorre
Fondos ARI (Assistencia Recerca Intensiva)
Instituto de Salud Carlos III
Fondo Social La Caixa
Investigators
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Principal Investigator: Carlos Fernandez de Larrea, MD,PhD Hospital Clinic of Barcelona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sara V. Latorre, Clinical Research Manager, Institut d'Investigacions Biomèdiques August Pi i Sunyer
ClinicalTrials.gov Identifier: NCT04309981    
Other Study ID Numbers: CARTBCMA-HCB-01
2019-001472-11 ( EudraCT Number )
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases