Clinical trial · Interventional
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
NCT04720313CI-TRIAL-00087209active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It is a phase one study with dose escalation and safety CART in BCMA- Expressing Multiple Myeloma and AL amyloidosis Patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dose Escalation and Safety | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NXC-201 (formerly HBI0101) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CART BCMA
- description
- The dose escalation phase (Part A) will include the following doses of CAR-positive (CAR+) T cells: 150×10\^6, 450×10\^6, 800×10\^6 or 1200 ×10\^6 The expansion phase (Part B) will include a dose between 450×10\^6 to 800×10\^6 CAR-positive (CAR+) T cells
- interventionNames
- Drug: NXC-201 (formerly HBI0101)
Primary outcomes (1)
- measure
- Determination of MTD
- timeFrame
- 21 days
- description
- Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )
Secondary outcomes (2)
- measure
- The overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 requirementsReferences
Publications (4)
- DERIVEDLebel E, Asherie N, Kfir-Erenfeld S, Grisariu S, Avni B, Elias S, Assayag M, Dubnikov-Sharon T, Pick M, Alexander-Shani R, Bessig N, Herr S, Shehadeh A, Ishtay A, Pimienta S, Vainstein V, Zimran E, Cohen Y, Avivi I, Cohen C, Stepensky P, Gatt ME. Efficacy and Safety of Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor T-Cell for the Treatment of Relapsed and Refractory AL Amyloidosis. J Clin Oncol. 2025 Jun 10;43(17):2007-2016. doi: 10.1200/JCO-24-02252. Epub 2024 Dec 9. PMID 39653116
- DERIVEDKfir-Erenfeld S, Asherie N, Lebel E, Vainstein V, Assayag M, Dubnikov Sharon T, Grisariu S, Avni B, Elias S, Alexander-Shani R, Bessig N, Shehadeh A, Ishtay A, Zelmanovich V, Zimran E, Pick M, Roziner I, Kenett RS, Cohen Y, Avivi I, Cohen CJ, Gatt ME, Stepensky P. Clinical evaluation and determinants of response to HBI0101 (BCMA CART) therapy in relapsed/refractory multiple myeloma. Blood Adv. 2024 Aug 13;8(15):4077-4088. doi: 10.1182/bloodadvances.2024012967. PMID 38768428
- DERIVEDAsherie N, Kfir-Erenfeld S, Avni B, Assayag M, Dubnikov T, Zalcman N, Lebel E, Zimran E, Shaulov A, Pick M, Cohen Y, Avivi I, Cohen C, Gatt ME, Grisariu S, Stepensky P. Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial. Haematologica. 2023 Jul 1;108(7):1827-1839. doi: 10.3324/haematol.2022.281628. PMID 36200421
- DERIVEDKfir-Erenfeld S, Asherie N, Grisariu S, Avni B, Zimran E, Assayag M, Sharon TD, Pick M, Lebel E, Shaulov A, Cohen YC, Avivi I, Cohen CJ, Stepensky P, Gatt ME. Feasibility of a Novel Academic BCMA-CART (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis. Clin Cancer Res. 2022 Dec 1;28(23):5156-5166. doi: 10.1158/1078-0432.CCR-22-0637. PMID 36107221