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Active, not recruiting Phase 1

NXC-201 (formerly HBI0101) Multiple Myeloma

NCT04720313 · tracked via the Priya Life Science Israel tracker
Phase
Phase 1
Started
2021-01-01
Last updated
2025-03-14

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

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
Hadassah University Hospital Jerusalem Jerusalem
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04720313 on ClinicalTrials.gov ↗ ← All trials in Israel