NCT04720313进行中（未招募）1 期
A Phase 1 Dose Escalation and Safety Study of NXC-201 (formerly HBI0101) CART in BCMA-Expressing Multiple Myeloma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Determination of MTD
研究概览
简要总结
It is a phase one study with dose escalation and safety CART in BCMA- Expressing Multiple Myeloma and AL amyloidosis Patients
详细描述
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 than the CD19 antigen targeted by KYMRIAHTM (tisagenlecleucel) and YESCARTATM (axicabtagene ciloleucel).
Importantly, successful results from at least three clinical trials of a BCMA targeted CAR T therapy were published (Zhao 2018, Brundo 2018, Raje 2019), with excellent results obtained for relapsed or refractory multiple myeloma (MM) patients, that validate the approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- 未提供
研究组 & 干预措施
CART BCMA
Experimental
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
干预措施: NXC-201 (formerly HBI0101) (Drug)
结局指标
主要结局
Determination of MTD
时间窗: 21 days
Part A: Determination of MTD Part B: Confirmation of selected dose tested (at or below MTD) ( safety )
次要结局
- The progression-free survival(2 years)
- The overall survival(2 years)
研究者
Polina Stepensky
Professor
Hadassah Medical Organization
研究点 (1)
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相关资讯
Advancements in Oncology: CAR-T Therapy for Myeloma, Cologuard Plus Approval, and NSCLC Treatment• HBI0101, a novel BCMA-directed CAR T-cell therapy, shows high efficacy and manageable safety in relapsed/refractory multiple myeloma patients, offering a promising treatment option.
• Cologuard Plus receives FDA approval as a noninvasive stool DNA test for colorectal cancer screening in adults 45 and older, demonstrating improved detection rates.
• Neoadjuvant nivolumab plus chemotherapy, followed by adjuvant nivolumab, gains FDA approval for operable stage IIA to IIIB non-small cell lung cancer, significantly improving event-free survival.
• Belantamab mafodotin-blmf combined with pomalidomide and dexamethasone shows meaningful improvements in relapsed/refractory multiple myeloma compared to bortezomib-based regimens.last yearImmix Biopharma's NXC-201 Receives EU Orphan Drug Designation for Multiple Myeloma• Immix Biopharma's NXC-201 has been granted Orphan Drug Designation by the European Commission for treating multiple myeloma, a rare and life-threatening condition.
• The designation provides NXC-201 with 10 years of market exclusivity in the EU upon approval, along with access to centralized authorization procedures.
• This regulatory milestone underscores NXC-201's potential clinical impact, particularly for frail relapsed/refractory multiple myeloma patients with limited treatment options.
• NXC-201 is currently being evaluated in the NEXICART-1 clinical trial, showing a favorable tolerability profile and potential for 'Single Day CRS'.2 years agoImmix Biopharma's NXC-201 CAR-T Therapy Shows Promise in AL Amyloidosis and Multiple Myeloma- Immix Biopharma's NXC-201, a BCMA-targeted CAR-T cell therapy, demonstrated a 100% overall response rate in relapsed/refractory AL amyloidosis patients in Phase 1/2a trials.
- The FDA has cleared the IND application for NXC-201, enabling U.S. patient dosing and expanding studies of the therapy in relapsed/refractory AL Amyloidosis.
- NXC-201 has also shown a 95% overall response rate in heavily pre-treated relapsed/refractory multiple myeloma patients with a median follow-up of 11.9 months.
- A virtual KOL event will be hosted to discuss NXC-201's potential as a treatment option for relapsed/refractory AL Amyloidosis, featuring experts in the field.2 years agoImmix Biopharma Completes Engineering Batch of NXC-201 CAR-T Therapy for U.S. Clinical Trial Expansion- Immix Biopharma successfully completed its third engineering batch of NXC-201, a BCMA-targeted CAR-T cell therapy, at its U.S. manufacturing site.
- This milestone supports the planned expansion of the NEXICART-1 clinical trial (NCT04720313) to include U.S. patients.
- NXC-201 has demonstrated a 100% overall response rate in relapsed/refractory AL Amyloidosis patients in earlier studies, receiving FDA Orphan Drug Designation.
- Immix Biopharma aims to position NXC-201 as a potential outpatient CAR-T therapy, expanding access beyond the current 5% of U.S. hospitals offering CAR-T treatments.2 years agoNXC-201 CAR T-Cell Therapy Shows Promise in Relapsed/Refractory AL Amyloidosis- NXC-201, a BCMA-directed CAR T-cell therapy, demonstrated a 100% hematologic overall response rate in relapsed/refractory AL amyloidosis patients.
- Organ responses were observed in 5 of 9 evaluable patients, indicating potential clinical benefit beyond hematologic improvement.
- Despite efficacy, a high incidence of cardiac-related deaths within the first year raises concerns about the therapy's safety profile in this frail population.
- The study highlights the feasibility of CAR T-cell therapy in AL amyloidosis, but also underscores the need for careful patient selection and management.2 years ago
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