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OncoMatch/Clinical Trials/NCT06097832

Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis

Is NCT06097832 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies NXC-201 CAR-T for light chain (al) amyloidosis.

Phase 1/2RecruitingNexcella Inc.NCT06097832Data as of May 2026

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).

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Extracted eligibility criteria

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)

Prior therapy

Min 1 prior line

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 →

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