OncoMatch/Clinical Trials/NCT06097832
Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis
Is NCT06097832 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies NXC-201 CAR-T for light chain (al) amyloidosis.
Treatment: NXC-201 CAR-T — 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).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Biomarker criteria
Required: CD38 prior exposure to monoclonal antibody
Patients should have received at least one line of therapy with a CD38 monoclonal antibody
Excluded: BCMA prior therapy targeting BCMA
Any therapy that is targeted to BCMA
Disease stage
Excluded: Stage STAGE IIIB PATIENTS: NT-PROBNP >8500 NG/L AND HS-TROPONIN I ≥100 NG/L OR TROPONIN I ≥0.1 MCG/L OR TROPONIN T ≥ 0.035 MCG/L OR HS-TROPONIN T ≥50 NG/L
Measurable hematologic disease: difference between involved and uninvolved FLC > 20 mg/L (or 2mg/dl) with an abnormal k/l ratio; or M-spike > 0.5mg/dl.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: CD38 monoclonal antibody
Patients should have received at least one line of therapy with a CD38 monoclonal antibody
Must have received: proteasome inhibitor
Patients should have received at least one line of therapy with a ... proteosome inhibitor
Cannot have received: CAR-T cell therapy
Prior treatment with CAR T therapy directed at any target
Cannot have received: BCMA-targeted therapy
Any therapy that is targeted to BCMA
Cannot have received: systemic therapy for AL amyloidosis
Any prior systemic therapy for AL amyloidosis within 14 days prior to leukapheresis
Cannot have received: systemic therapy for AL amyloidosis
Any prior systemic therapy for AL amyloidosis within 14 days of leukapheresis
Cannot have received: investigational treatment
Wash-out period of at least 4 weeks from previous investigational treatment prior to leukapheresis
Lab requirements
Blood counts
ANC <1000 cells/mm3, platelet count <50,000/mm3, hemoglobin <8 g/dL, absolute lymphocyte count <300 cells/mm3 excluded
Kidney function
creatinine clearance (CRCL) <20 mL/min excluded
Liver function
AST/ALT >3 x ULN, alkaline phosphatase >2 x ULN, serum direct bilirubin >2 x ULN excluded
Cardiac function
Left ventricular ejection fraction <35% excluded; NYHA Heart Failure Class III or IV excluded; significant arrhythmias, heart failure related to ischemic heart disease, and chronic atrial fibrillation with uncontrolled heart rate excluded
Inadequate hepatic function: AST/ALT >3 x ULN, alkaline phosphatase >2 x ULN, serum direct bilirubin >2 x ULN. Inadequate renal function: creatinine clearance (CRCL) <20 mL/min. Inadequate bone marrow function: ANC <1000 cells/mm3, platelet count <50,000/mm3, hemoglobin <8 g/dL, absolute lymphocyte count <300 cells/mm3. Left ventricular ejection fraction <35%. NYHA Heart Failure Class III or IV.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sutter Health Alta Bates · Berkeley, California
- City of Hope · Duarte, California
- University of California Los Angeles · Los Angeles, California
- University of California Davis Medical Center · Sacramento, California
- Stanford University · Stanford, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06097832 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, BCMA-targeted therapy, systemic therapy for AL amyloidosis disqualifies patients from enrollment.
Does this trial require CD38?
Yes, CD38 prior exposure to monoclonal antibody is a required biomarker for enrollment.
Are patients with BCMA alterations eligible?
No. BCMA prior therapy targeting BCMA is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 120 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify