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A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma

Sponsor
Janssen Scientific Affairs, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05347485
Collaborator
(none)
20
Enrollment
24
Locations
1
Arm
47.8
Anticipated Duration (Months)
0.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

Condition or Disease Intervention/Treatment Phase
  • Drug: Cilta-cel
  • Drug: Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma
Actual Study Start Date :
May 13, 2022
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
May 8, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ciltacabtagene Autoleucel (Cilta-cel)

Eligible participants will receive bridging therapy (that is, anti-plasma cell directed treatment) based on participant's clinical status and timing of availability of cilta-cel (JNJ-68284528) along with lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square [mg/m^2] intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants will receive a single IV infusion of cilta-cel (JNJ-68284528) at a total targeted dose of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg).

Drug: Cilta-cel
Cilta-cel will be administered as an IV infusion.
Other Names:
  • JNJ-68284528

    • Drug: Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
    Lymphodepleting therapy (cyclophosphamide and fludarabine) will be administered intravenously.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [Consenting Phase through End of Study (EOS) (Up to 4 years)]

      ORR is defined as percentage of participants who achieve partial response or better according to international myeloma working group (IMWG) response criteria.

    Secondary Outcome Measures

    1. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Up to 4 years]

      Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.

    2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity [Up to 4 years]

      TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE.

    3. Number of Participants with Serious Adverse Events (SAEs) [Up to 4 years]

      SAE is any untoward medical occurrence that results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

    4. Number of Participants with Clinically Significant Abnormalities in Safety Laboratory Tests [Up to 4 years]

      Number of participants with clinically significant abnormalities in laboratory safety tests (such as serum chemistry, hematology, infectious diseases testing, and urinalysis) will be reported.

    5. Number of Participants with Clinically Significant Abnormalities in Vital Signs [Up to 4 years]

      Number of participants with clinically significant abnormalities in vital signs (including temperature, pulse/heart rate, respiratory rate, oxygen saturation, and blood pressure) will be reported.

    6. Number of Participants with Clinically Significant Abnormalities in Physical Examination [Up to 4 years]

      Number of participants with clinically significant abnormalities in physical examination will be reported.

    7. Partial Response (PR) Rate [Up to 4 years]

      PR rate is defined as percentage of participants who achieve PR according to IMWG response criteria.

    8. Very Good Partial Response (VGPR) Rate [Up to 4 years]

      VGPR rate is defined as percentage of participants who achieve VGPR according to IMWG response criteria.

    9. Complete Response (CR) Rate [Up to 4 years]

      CR rate is defined as percentage of participants who achieve CR according to IMWG response criteria.

    10. Stringent Complete Response (sCR) Rate [Up to 4 years]

      sCR rate is defined as percentage of participants who achieve sCR according to IMWG response criteria.

    11. Clinical Benefit Rate (CBR) [Up to 4 years]

      CBR (CBR=ORR [sCR+CR+VGPR+PR]+minimal response [MR]) is defined as percentage of participants who achieve CBR according to IMWG response criteria.

    12. Duration of Response (DOR) [Up to 4 years]

      DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG response criteria.

    13. Progression Free Survival (PFS) [Up to 4 years]

      PFS defined as the time from the date of the initial infusion of cilta-cel out-of-specification (OOS) to the date of first documented disease progression, as defined in the IMWG response criteria, or death due to any cause, whichever occurs first.

    14. Overall Survival (OS) [Up to 4 years]

      OS is measured from the date of the initial infusion of cilta-cel OOS to the date of the participant's death. If the participant is alive or the vital status is unknown, then the participant's data will be censored at the date the participant was last known to be alive.

    15. Minimal Residual Disease (MRD) Negative Rate [Up to 4 years]

      MRD negative rate is defined as the percentage of participants in CR with negative MRD status.

    16. Number of Participants with Presence of Replication Competent Lentivirus [Up to 4 years]

      Number of participants with presence of replication competent lentivirus will be reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label

    • Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator

    • Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)

    • Meets the criteria to receive lymphodepleting chemotherapy

    • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at consenting and prior to the first dose of cyclophosphamide and fludarabine

    Exclusion Criteria:

    • History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant

    • Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI

    • Hepatitis B infection

    • Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C

    • Seropositive for human immunodeficiency virus (HIV)

    • Uncontrolled autoimmune disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Duarte California United States 91010
    2 University of California, San Francisco San Francisco California United States 94143
    3 Stanford University Medical Center Stanford California United States 94305
    4 Colorado Blood Cancer Institute Denver Colorado United States 80218
    5 Mayo Clinic Jacksonville Florida United States 32224
    6 University of Miami Miami Florida United States 33136
    7 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    8 Emory University Atlanta Georgia United States 30322
    9 Northwestern University Chicago Illinois United States 60611
    10 Kansas University Medical Center Westwood Kansas United States 66205
    11 Massachusetts General Hospital Boston Massachusetts United States 02114
    12 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    13 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    14 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    15 Mayo Clinic - Rochester Rochester Minnesota United States 55905
    16 Washington University School of Medicine Saint Louis Missouri United States 63110
    17 Hackensack University Medical Center Hackensack New Jersey United States 07601
    18 Mount Sinai Medical Center New York New York United States 10029
    19 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    20 Levine Cancer Institute Charlotte North Carolina United States 28204
    21 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
    22 MD Anderson Cancer Center Houston Texas United States 77030
    23 University of Washington-Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    24 Medical College Of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Janssen Scientific Affairs, LLC

    Investigators

    • Study Director: Janssen Scientific Affairs, LLC Clinical Trial, Janssen Scientific Affairs, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Scientific Affairs, LLC
    ClinicalTrials.gov Identifier:
    NCT05347485
    Other Study ID Numbers:
    • CR109014
    • 68284528MMY2005
    First Posted:
    Apr 26, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Cyclophosphamide
    Fludarabine

    Study Results

    No Results Posted as of Aug 3, 2022