Active, not recruiting
Phase 1
NXC-201 (formerly HBI0101) Multiple Myeloma
Condition(s) studied
Dose Escalation and Safety
Investigational drug(s) / intervention(s)
NXC-201 (formerly HBI0101)
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.
Study summary
It is a phase one study with dose escalation and safety CART in BCMA- Expressing Multiple Myeloma and AL amyloidosis Patients
Eligibility
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
Primary outcome measure(s)
- Determination of MTD — 21 days
Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )
Trial sites (1)
| Facility | City | Region | Status |
| Hadassah University Hospital |
Jerusalem |
Jerusalem |
|
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