NXC-201 (Formerly HBI0101) Multiple Myeloma

Phase 1

Recruiting

• Conditions: Dose Escalation and Safety
• Interventions: Drug: NXC-201 (formerly HBI0101)

• Registration Number: NCT04720313
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-22
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-30
• Last Update Posted: 2023-05-03
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CART BCMA	NXC-201 (formerly HBI0101)	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

Primary Outcome Measures

Name	Time	Method
Determination of MTD	21 days	Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )

Secondary Outcome Measures

Name	Time	Method
The progression-free survival	2 years	according to the IMWG Uniform Response Criteria for Multiple Myeloma
The overall survival	2 years	according to the IMWG Uniform Response Criteria for Multiple Myeloma

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel