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BCMA-directed CAR-T Cell Therapy in Adult Patients With Relapsed and/or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318327
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated as a single agent in relapsed/refractory multiple myeloma

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: PHE885 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I, Open Label, Study of B-cell Maturation Antigen (BCMA)-Directed CAR-T Cells in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date : July 23, 2020
Estimated Primary Completion Date : March 2, 2023
Estimated Study Completion Date : March 2, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: PHE885
Patients will receive PHE885
 Biological: PHE885
Infusion


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose limiting toxicities (DLT) [ Time Frame: 24 months ]
    Incidence of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

  2. Nature of Dose limiting toxicities (DLT) [ Time Frame: 24 months ]
    Nature of Dose Limiting Toxicities (DLTs) during the first 28 days after anti-BCMA CAR-T cell administration

  3. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Manufacture success rate (defined as number of subjects treated with planned target dose divided by total number of subjects treated) [ Time Frame: 24 Months ]
    evaluate the feasibility of the manufacturing process

  2. ORR (overall response rate): Proportion of subjects with the best overall response (BOR) [ Time Frame: month 3, month 6 ]
    BOR (best overall response) of sCR (stringent complete response) +CR (complete response) +VGPR (very good partial response)+PR (partial response) at Months 3 and 6, as determined by local investigator using the IMWG (International Myeloma Working Group) Criteria (Kumar et al, 2016)

  3. CRR (complete response rate) [ Time Frame: 3 months ]
    Proportion of subjects with the BOR of sCR+CR at Month 3, as determined by local investigator using the IMWG Criteria.

  4. DOR (duration of response) [ Time Frame: 12 months ]
    as assessed by local investigator: the time from achievement of sCR+CR+VGPR+PR to relapse or death due to MM (multiple myeloma)

  5. Cmax of BCMA CAR-T cells [ Time Frame: 24 months ]
    through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow

  6. Tmax of BCMA CAR-T cells [ Time Frame: 24 months ]
    through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow

  7. AUC of BCMA CAR-T cells [ Time Frame: 24 months ]
    through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow

  8. Clast of BCMA CAR-T cells [ Time Frame: 24 months ]
    through qPCR-detected transgene of CART concentrations over time in peripheral blood and bone marrow

  9. number of patients with pre-existing and treatment induced immunogenicity (cellular and humoral) of BCMA CAR-T cell therapy [ Time Frame: 24 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with MM who are relapsed and/or refractory to at least 2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab), if available, and have documented evidence of disease progression (IMWG criteria)
  • Measurable disease as defined by the protocol
  • ECOG performance status that is either 0 or 1 at screening
  • Adequate hematological values
  • Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Exclusion Criteria:

  • Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. Patients who have received prior BCMA-directed bi-specific antibodies or antibody-drug conjugates (ADC) are not excluded.
  • Autologous HSCT within 6 weeks prior to enrollment or any prior history of allogeneic hematopoietic stem cell transplant (HSCT)
  • Chemotherapy or any concomitant anti-cancer therapies (other than protocol prescribed lymphodepletion (LD) chemotherapy) within 2 weeks prior to apheresis
  • Treatment with small molecule targeted antineoplastics within 2 weeks of apheresis collection or 5 half-lives whichever is shorter
  • Have received antibodies or immunotherapies (other than daratumumab) within 4 weeks prior to apheresis collection. Daratumumab within 3 weeks prior to apheresis collection.
Contacts and Locations
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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): NCT04318327


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Alejandro Alonso    617-632-4295    Alejandro_Alonso@dfci.harvard.edu   
Principal Investigator: Adam Sperling         
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04318327    
Other Study ID Numbers: CADPT07A12101
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple myeloma, B-cell maturation antigen, BCMA, anti-BCMA, BCMA-directed, chimeric antigen receptor, CAR-T, PHE885
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