AL Amyloidosis Clinical Trials Recruiting Now: NXC-201 CAR-T Cell Therapy Study at 5 Major US Centers
A new Phase 1/2 trial (NCT06097832) is recruiting at 5 major US academic centers to test NXC-201, a BCMA-targeted CAR-T cell therapy, in relapsed/refractory AL amyloidosis. Learn about the trial design, key eligibility, site locations, and how Corterve helps patients connect with recruiting studies.
AL Amyloidosis Clinical Trials Recruiting Now: NXC-201 CAR-T Cell Therapy Study at 5 Major US Centers
Light chain (AL) amyloidosis is a rare, progressive disease caused by misfolded immunoglobulin light chains produced by clonal plasma cells. These amyloid fibrils deposit in vital organs — heart, kidneys, liver, nerves — leading to organ dysfunction and, without effective treatment, median survival of just 6–12 months in advanced cardiac involvement. While standard therapies (proteasome inhibitors, immunomodulatory drugs, daratumumab-based regimens) can achieve hematologic responses, many patients relapse or are ineligible for autologous stem cell transplant. There remains a critical need for deeper, more durable responses, particularly in patients with advanced cardiac amyloidosis.
A new Phase 1/2, open-label, multicenter trial is now recruiting to evaluate NXC-201, an investigational BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy, in patients with relapsed/refractory AL amyloidosis.
Actively Recruiting Trial: NXC-201 CAR-T in AL Amyloidosis (NCT06097832)
NCT ID: NCT06097832
Sponsor: Nexcella, Inc.
Phase: 1/2
Status: ACTIVE_NOT_RECRUITING (overall) — 5 US sites currently RECRUITING
Study Design: Open-label, dose-escalation (Phase 1) followed by dose-expansion (Phase 2)
Intervention: NXC-201 autologous BCMA CAR-T cells following lymphodepleting chemotherapy
Estimated Enrollment: ~60 participants
Primary Outcomes (Phase 1): Safety, tolerability, maximum tolerated dose, recommended Phase 2 dose
Primary Outcomes (Phase 2): Hematologic complete response (CR) rate at 3 months per consensus criteria
Key Secondary Outcomes: Organ response (cardiac, renal), overall response rate, duration of response, MRD negativity, progression-free survival, overall survival
Key Eligibility Highlights
- Diagnosis: Confirmed AL amyloidosis per consensus criteria (amyloid deposits + monoclonal protein)
- Disease Status: Relapsed or refractory after ≥2 prior lines of therapy (including a proteasome inhibitor AND an anti-CD38 antibody, e.g., daratumumab)
- Organ Involvement: Cardiac (NT-proBNP > 1800 pg/mL or echocardio evidence), renal (proteinuria > 0.5 g/day), or other measurable organ involvement
- Performance Status: ECOG 0–2
- Key Exclusions: Prior BCMA-targeted therapy, prior CAR-T, active uncontrolled infection, significant cardiac dysfunction (LVEF < 40%, NYHA Class IV), eGFR < 30 mL/min
Full eligibility criteria available at ClinicalTrials.gov (NCT06097832). Eligibility is determined by the study team at each site.
US Recruiting Sites (5 Active Locations)
| Site | City, State | Principal Investigator / Contact |
|---|---|---|
| Sutter Health Alta Bates / James Graham Brown Cancer Center | Berkeley, CA | Site 0004 |
| City of Hope | Duarte, CA | Site 0001 |
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles, CA | Site 0005 |
| UC Davis Medical Center | Sacramento, CA | Site 0002 |
| Stanford Health Care | Stanford, CA | Site 0003 |
All five sites are major academic medical centers with dedicated amyloidosis programs and CAR-T infrastructure. Site statuses are current as of ClinicalTrials.gov last update; confirm recruiting status directly with the study coordinator before referral.
Why This Trial Matters: CAR-T in AL Amyloidosis — Context & Comparison
| Feature | Standard of Care (Current) | NXC-201 CAR-T (Investigational) |
|---|---|---|
| Mechanism | Plasma cell depletion (proteasome inhibitors, anti-CD38, chemotherapy) | Engineered T cells targeting BCMA on plasma cells |
| Depth of Response | CR rates 30–50% in frontline; lower in relapsed/refractory | Early-phase CAR-T in myeloma shows CR/sCR >70% |
| Durability | Median PFS 12–30 months (relapsed setting) | CAR-T in myeloma: median PFS 12–24+ months; durability under study in amyloidosis |
| Organ Recovery | Cardiac/renal response correlates with hematologic CR | Hypothesis: deeper hematologic response → higher organ response rates |
| Treatment Burden | Chronic, ongoing cycles | Single infusion after lymphodepletion; potential finite therapy |
| Key Risks | Neuropathy, cytopenias, infection, cardiac toxicity | CRS (typically Grade 1–2), ICANS, cytopenias, infection; requires REMS center |
Clinical Rationale: BCMA (B-cell maturation antigen) is highly expressed on clonal plasma cells driving AL amyloidosis. NXC-201 uses a novel BCMA-targeted CAR construct designed for enhanced persistence and reduced tonic signaling. Early data in relapsed/refractory multiple myeloma (NCT04722099) showed an overall response rate of 93% with 67% CR/sCR and manageable safety (CRS Grade 1–2 in majority). This trial extends that platform to AL amyloidosis, where plasma cell eradication is the therapeutic goal.
How Corterve Helps Patients Find This Trial
- Search by condition — Visit
corterve.com/trials?condition=AL+amyloidosisto see all actively recruiting AL amyloidosis studies. - Match your profile — Enter your ZIP code, travel radius, and key clinical details (organ involvement, prior therapies) to see which sites you may qualify for.
- Pre-qualification screener — Answer 5–6 targeted questions (age, diagnosis confirmation, prior lines, cardiac/renal markers, performance status) to assess basic eligibility before contacting a site.
- Consent & referral — If pre-qualified, provide consent and Corterve sends a structured referral to the study team at your chosen site(s).
- Site takes over — The clinical site conducts full screening, informed consent, and enrollment. Corterve does not make medical decisions or guarantee eligibility.
No matches near you? Join the waitlist with your email and ZIP — Corterve re-runs matching daily as new trials open and your profile updates.
Questions to Ask Your Hematologist / Amyloidosis Specialist
- Based on my prior therapies and organ involvement, would I meet the key inclusion criteria for NCT06097832?
- How does the risk/benefit of CAR-T compare to another line of standard therapy (e.g., daratumumab retreatment, clinical trial of bispecific antibody)?
- What is the expected timeline from referral to leukapheresis to infusion at this center?
- What supportive care (bridging therapy, CRS/ICANS monitoring, inpatient stay) does the center provide?
- Are there other recruiting AL amyloidosis trials (bispecifics, novel agents) I should consider in parallel?
Find This Trial on Corterve
Direct link: https://corterve.com/trials?condition=AL+amyloidosis
Trial detail page: https://corterve.com/trials/NCT06097832 (once live)
Disclaimer
Corterve is a clinical trial matching platform, not a medical provider. We do not provide medical advice, diagnose conditions, or guarantee trial eligibility or enrollment. All eligibility determinations are made solely by the clinical study team at each site. The information above is sourced from ClinicalTrials.gov (NCT06097832) and public sponsor disclosures as of the last-verified date below. Trial status, locations, and criteria can change without notice. Discuss all treatment options with your licensed hematologist/oncologist. Corterve does not endorse any specific trial, sponsor, or investigational product.
Last verified: 2026-07-23
Sources: ClinicalTrials.gov NCT06097832; Nexcella, Inc. pipeline disclosures; ASH 2023/2024 abstracts on NXC-201 in multiple myeloma; consensus criteria for AL amyloidosis (Kumar et al., Blood 2019).