HB10101 Multiple Myeloma

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Recruiting

CT.gov ID

NCT04720313

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dose Escalation and Safety	Drug: CART BCMA	Phase 1

Detailed Description

The intention with 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. The CAR vector employed for HBI0101 CART is almost identical to the vector employed for the clinical study reported by Raje 2019, therefore, a strong therapeutic response is expected also for HBI0101 CART together with a similar manageable safety profile

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Multiple Myeloma PatientsMultiple Myeloma Patients

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in BCMA-Expressing

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

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: CART BCMA 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 HBI0101 CART is provided fresh without cryopreservation.

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: CART BCMA

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 HBI0101 CART is provided fresh without cryopreservation.

Outcome Measures

Primary Outcome Measures

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

The overall survival [2 years]
according to the IMWG Uniform Response Criteria for Multiple Myeloma
The progression-free survival [2 years]
according to the IMWG Uniform Response Criteria for Multiple Myeloma

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hadassah University Hospital	Jerusalem		Israel	91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator: Polina Stepensky, prof., Hadassah university hospital of Jerusalem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Polina Stepensky, Professor, Hadassah Medical Organization

ClinicalTrials.gov Identifier:

NCT04720313

Other Study ID Numbers:

MOH_2020-12-22_009584

First Posted:

Jan 22, 2021

Last Update Posted:

Jan 22, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 22, 2021