HB10101 Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Jan 3, 2026
  • participants needed
    48
  • sponsor
    Hadassah Medical Organization
Updated on 3 February 2021

Summary

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

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

Details
Condition Dose Escalation and Safety
Treatment CART BCMA
Clinical Study IdentifierNCT04720313
SponsorHadassah Medical Organization
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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