Phase 1b/2 Study of NXC-201 for the Treatment of Patients With Relapsed or Refractory AL Amyloidosis

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• ≥18 years of age.

• Voluntarily signed informed consent form (ICF).

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Histologically proven systemic AL amyloidosis confirmed by positive Congo red staining with green birefringence on polarized light microscopy in an organ outside the bone marrow and evidence of a measurable clonal plasma cell disease that requires active treatment.

∙ An underlying plasma cell disorder can be identified by one of the following: clonal plasma cells in the BM, monoclonal protein in the serum or urine, or abnormal free light chain ratio.

‣ Because AL amyloidosis may present with low volumes of bone marrow plasma cells, prior biopsies demonstrating clonal plasma cell populations may be used to determine eligibility.

‣ 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.

• Patients should have received at least one line of therapy with a CD38 monoclonal antibody and a proteosome inhibitor and not be in VGPR or CR at the time of inclusion. Patients who did not reach VGPR after two cycles of initial therapy or patients who did achieve VGPR or better but with a hematological relapse can be included.

• Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).

• 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.

• Absence of any psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before trial entry.

⁃ Able to swallow pills.

Locations
United States
California
Sutter Health Alta Bates
RECRUITING
Berkeley
City of Hope
RECRUITING
Duarte
University of California Los Angeles
RECRUITING
Los Angeles
University of California Davis Medical Center
RECRUITING
Sacramento
Stanford University
RECRUITING
Stanford
Georgia
Winship Cancer Institute, Emory University
RECRUITING
Atlanta
Kansas
The University of Kansas Cancer Center
RECRUITING
Fairway
Massachusetts
Boston University Medical Center
RECRUITING
Boston
Tufts Medical Center
RECRUITING
Boston
Michigan
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
Masonic Cancer Center, University of Minnesota
RECRUITING
Minneapolis
Missouri
Washington University Siteman Cancer Center
RECRUITING
St Louis
New York
Memorial Sloan Kettering Comprehensive Cancer Center
RECRUITING
New York
Ohio
University of Cincinnati Cancer Center
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Tennessee
Baptist Memorial Hospital
RECRUITING
Memphis
Utah
Huntsman Cancer Institute at the University of Utah
RECRUITING
Salt Lake City
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Contact Information
Primary
Nexcella
clinicaltrials@nexcella.com
310-773-0664
Time Frame
Start Date: 2024-06-05
Estimated Completion Date: 2039-01
Participants
Target number of participants: 40
Treatments
Experimental: NXC-201 CAR-T
The dose escalation phase will include the following doses:~Cohort 1 - 150×10\^6 CAR-positive (CAR+) T cells (3 patients) Cohort 2 - 450×10\^6 CAR-positive (CAR+) T cells (3 patients) The dose expansion phase will then proceed.
Related Therapeutic Areas
Sponsors
Collaborators: Immix Biopharma, Inc.
Leads: Nexcella Inc.

This content was sourced from clinicaltrials.gov