Status:
ACTIVE_NOT_RECRUITING
NXC-201 (formerly HBI0101) Multiple Myeloma
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Nexcella Inc.
Conditions:
Dose Escalation and Safety
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
It is a phase one study with dose escalation and safety CART in BCMA- Expressing Multiple Myeloma and AL amyloidosis Patients
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04720313
Start Date
January 1 2021
End Date
January 1 2027
Last Update
March 14 2025
Active Locations (1)
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1
Hadassah University Hospital
Jerusalem, Jerusalem, Israel, 91120