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NXC-201 (Formerly HBI0101) 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: NCT04720313
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : May 3, 2023
Sponsor:
Collaborator:
Nexcella Inc.
Information provided by (Responsible Party):
Polina Stepensky, Hadassah Medical Organization

Study Description
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Brief Summary:
It is a phase one study with dose escalation and safety CART in BCMA- Expressing Multiple Myeloma and AL amyloidosis Patients

Condition or disease Intervention/treatment Phase
Dose Escalation and Safety Drug: NXC-201 (formerly HBI0101) Phase 1

Detailed Description:

The intention with NXC-201 (formerly HBI0101) CART is to follow the chimeric antigen receptor T-cells (CART) approach, as for approved products, but target the B cell maturation antigen (BCMA) rather than the CD19 antigen targeted by KYMRIAHTM (tisagenlecleucel) and YESCARTATM (axicabtagene ciloleucel).

Importantly, successful results from at least three clinical trials of a BCMA targeted CAR T therapy were published (Zhao 2018, Brundo 2018, Raje 2019), with excellent results obtained for relapsed or refractory multiple myeloma (MM) patients, that validate the approach.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multiple Myeloma and AL amyloidosis Patients
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation and Safety Study of NXC-201 (Formerly HBI0101) CART in BCMA-Expressing Multiple Myeloma Patients
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CART BCMA
The dose escalation phase (Part A) will include the following doses of CAR-positive (CAR+) T cells: 150×10^6, 450×10^6, 800×10^6 or 1200 ×10^6 The expansion phase (Part B) will include a dose between 450×10^6 to 800×10^6 CAR-positive (CAR+) T cells
 Drug: NXC-201 (formerly HBI0101)
NXC-201 (formerly HBI0101) CART is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The NXC-201 (formerly HBI0101) CART is provided fresh without cryopreservation.


Outcome Measures
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Primary Outcome Measures :
  1. Determination of MTD [ Time Frame: 21 days ]
    Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )


Secondary Outcome Measures :
  1. The overall survival [ Time Frame: 2 years ]
    according to the IMWG Uniform Response Criteria for Multiple Myeloma

  2. The progression-free survival [ Time Frame: 2 years ]
    according to the IMWG Uniform Response Criteria for Multiple Myeloma


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years of age

    • Voluntarily signed informed consent form (ICF)
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
    • Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor, immunomodulatory therapy and at least one antibody therapy.

    • Subjects must have measurable disease, including at least one of the criteria below:

      • Serum M-protein greater or equal to 0.5 g/dL
      • Urine M-protein greater or equal to 200 mg/24 h
      • Serum free light chain (FLC) assay: involved FLC level greater or equal to 5 mg/dL (50 mg/L) provided serum FLC ratio is abnormal
      • A biopsy-proven evaluable plasmacytoma
      • Bone marrow plasma cells > 20% of total bone marrow cells
      • Non secretory patient will be allowed provided they have measurable disease by PET-CT or bone marrow aspiration, as designated.
    • Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study
    • Recovery to ≤Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy
    • Ability and willingness to adhere to the study visit schedule and all protocol requirements
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): NCT04720313


Contacts
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Contact: Polina Stepensky, Prof 972-26777803 polina@hadassah.org.il
Contact: Ella Dardac, BSc +972585852136 ellad@hadassah.org.il

Locations
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Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Polina Stepensky, Prof    972-26777803    polina@hadassah.org.il   
Contact: liliane Dray, NSC    972-26777260    lilane@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
Nexcella Inc.
Investigators
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Principal Investigator: Polina Stepensky, prof. Hadassah university hospital of Jerusalem
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Polina Stepensky, Professor, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT04720313    
Other Study ID Numbers: MOH_2020-12-22_009584
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There will be no IPD sharing

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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