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

  • Clinicaltrials.gov identifier

    NCT04318327

  • Recruitment Status

    Recruiting

  • First Posted

    March 23, 2020

  • Last update posted

    July 27, 2021

Study Description

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:Multiple Myeloma
  • Intervention/Treatment: Biological: PHE885
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • 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 2020
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: November 2023

Arms and interventions

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

Outcome Measures

  • 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

  • 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

Contacts

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

Contact: Novartis Pharmaceuticals

Locations

United States, Illinois
University of Chicago Medical Center Hematology and Oncology
Chicago

United States, Massachusetts
Massachusetts General Hospital
Boston

United States, Massachusetts
Beth Israel Deaconess Medical Cente KS121
Boston

United States, Massachusetts
Dana-Farber Cancer Institute
Boston

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

  • Responsible Party: Novartis Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT04318327 History of Changes
  • Other Study ID Numbers: CADPT07A12101
  • First Posted: March 23, 2020 Key Record Dates
  • Last Update Posted: July 27, 2021
  • Last Verified: July 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Novartis Pharmaceuticals: Multiple myeloma, B-cell maturation antigen, BCMA, anti-BCMA, BCMA-directed, chimeric antigen receptor, CAR-T, PHE885
  • Additional relevant MeSH terms: Multiple Myeloma Neoplasms, Plasma Cell