NXC-201 (Formerly HBI0101) Multiple Myeloma

Dose Escalation and Safety Clinical Trial

Official title:

A Phase 1 Dose Escalation and Safety Study of NXC-201 (Formerly HBI0101) CART in BCMA-Expressing Multiple Myeloma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720313
• Other study ID #: MOH_2020-12-22_009584
• Status: Recruiting
• Phase: Phase 1
• Start date: January 1, 2021
• Est. completion date: January 2026

Study information

• Verified date: April 2023
• Source: Hadassah Medical Organization
• Contact: Polina Stepensky, Prof
• Phone: 972-26777803
• Email: polina[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Dose Escalation and Safety
• Multiple Myeloma

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Nexcella, Inc

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of MTD	Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )	21 days
Secondary	The overall survival	according to the IMWG Uniform Response Criteria for Multiple Myeloma	2 years
Secondary	The progression-free survival	according to the IMWG Uniform Response Criteria for Multiple Myeloma	2 years