NCT04720313Active, not recruitingPhase 1
NXC-201 (formerly HBI0101) Multiple Myeloma
A Phase 1 Dose Escalation and Safety Study of NXC-201 (formerly HBI0101) CART in BCMA-Expressing Multiple Myeloma Patients
Source: ClinicalTrials.gov · Last updated 14 Mar 2025
Brief summary (registry, in English)
It is a phase one study with dose escalation and safety CART in BCMA- Expressing Multiple Myeloma and AL amyloidosis Patients
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 20 Jan 2021
- Start date
- 1 Jan 2021
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Hadassah Medical Organization
- Diseases
- Multiple myeloma
- NCT number
- NCT04720313
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 160
- From 1 Jan 2021 to the primary completion date, 31 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- ≥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
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hadassah University Hospital Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.