NXC-201 (Formerly HBI0101) Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT04720313|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : May 3, 2023
|Condition or disease||Intervention/treatment||Phase|
|Dose Escalation and Safety||Drug: NXC-201 (formerly HBI0101)||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multiple Myeloma and AL amyloidosis Patients|
|Masking:||None (Open Label)|
|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|
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.
- Determination of MTD [ Time Frame: 21 days ]Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )
- The overall survival [ Time Frame: 2 years ]according to the IMWG Uniform Response Criteria for Multiple Myeloma
- The progression-free survival [ Time Frame: 2 years ]according to the IMWG Uniform Response Criteria for Multiple Myeloma
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
|Contact: Polina Stepensky, Proffirstname.lastname@example.org|
|Contact: Ella Dardac, BScemail@example.com|
|Principal Investigator:||Polina Stepensky, prof.||Hadassah university hospital of Jerusalem|