Actively Recruiting
Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis
Led by Nexcella Inc. · Updated on 2025-07-10
40
Participants Needed
18
Research Sites
760 weeks
Total Duration
On this page
Sponsors
N
Nexcella Inc.
Lead Sponsor
I
Immix Biopharma, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Open-label Phase 1b Dose Escalation/Dose Expansion study exploring the safety and efficacy of NXC-201 in patients with relapsed or refractory light chain amyloidosis (AL).
CONDITIONS
Official Title
Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Signed informed consent form voluntarily
- ECOG performance status of 0 to 2
- Systemic AL amyloidosis confirmed by Congo red staining with green birefringence outside bone marrow
- Evidence of measurable clonal plasma cell disease needing active treatment
- Identifiable plasma cell disorder by bone marrow clonal plasma cells, serum or urine monoclonal protein, or abnormal free light chain ratio
- Measurable hematologic disease defined by involved-uninvolved free light chain difference > 20 mg/L or M-spike > 0.5 mg/dl
- Received at least one therapy line including a CD38 monoclonal antibody and proteasome inhibitor and not in very good partial response or complete remission at inclusion
- Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system)
- Women of child-bearing potential must have negative pregnancy test before treatment and agree to effective birth control
- Recovery to Grade 2 or baseline for any non-hematologic toxicities from prior treatments except alopecia and Grade 3 neuropathy
- No psychological, familial, sociological, or geographical conditions that may interfere with compliance
- Able to swallow pills
You will not qualify if you...
- Prior treatment with CAR T therapy targeting any antigen
- Any therapy targeting BCMA
- Stroke or seizure within 6 months before consent
- Bone marrow plasma cells >30% with symptomatic multiple myeloma and end organ damage
- New York Heart Association Heart Failure Class III or IV
- Systemic therapy for AL amyloidosis within 14 days prior to leukapheresis
- Therapeutic steroid doses within 2 weeks prior to leukapheresis (physiological replacement doses allowed)
- Less than 4 weeks washout from prior investigational treatment before leukapheresis
- Inadequate liver function (AST/ALT >3x ULN, alkaline phosphatase >2x ULN, direct bilirubin >2x ULN)
- Inadequate kidney function with creatinine clearance <20 mL/min
- INR or PTT >1.5x ULN unless stable anticoagulation for thromboembolism
- Low bone marrow function before leukapheresis or lymphodepletion without recent transfusion or growth factor support
- Active infection within 72 hours prior to lymphodepletion
- Significant co-morbid conditions posing undue risk as judged by investigator
- HIV positive without undetectable viral load on therapy within 6 months before lymphodepletion
- Active Hepatitis B or C with detectable viral load
- History of stroke, unstable angina, or myocardial infarction requiring intervention within 3 months
- Clinically significant ventricular arrhythmias despite treatment unless pacemaker or defibrillator implanted
- Stage IIIb patients with very high NT-proBNP and troponin levels
- Left ventricular ejection fraction below 35%
- Heart failure related to ischemic heart disease
- Other active malignancy requiring treatment except certain early-stage or treated cancers
- Recent venous thromboembolism with unstable anticoagulation or recent significant bleeding
- Non-AL amyloidosis diagnosis
- AL amyloidosis with only soft tissue involvement
- Low supine systolic blood pressure (<100 mmHg) or persistent postural symptoms
- Pregnant, breastfeeding, or planning pregnancy
- Medical conditions making study drug hazardous (e.g., uncontrolled diabetes, COPD, asthma, coronary artery disease)
- Chronic atrial fibrillation with uncontrolled heart rate
- Unwillingness to use effective birth control
- Inability to comply with study protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Sutter Health Alta Bates
Berkeley, California, United States, 94704
Actively Recruiting
2
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
3
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
4
University of California Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
5
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
6
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
7
The University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
Actively Recruiting
8
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
9
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
10
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
Washington University Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
13
Memorial Sloan Kettering Comprehensive Cancer Center
New York, New York, United States, 10065
Actively Recruiting
14
University of Cincinnati Cancer Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
15
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
16
Baptist Memorial Hospital
Memphis, Tennessee, United States, 381202127
Actively Recruiting
17
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
18
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
N
Nexcella
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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