HB10101 Multiple Myeloma

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization

Criteria

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