Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis
Part of paid clinical trials in Berkeley, California.
- Sponsor
- Nexcella Inc.
- Study ID
- NCT06097832
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Light Chain (AL) Amyloidosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 120 Years
- Healthy Volunteers
- Not accepted
Interventions
- NXC-201 CAR-T — BIOLOGICALNXC-201 (formerly HBI0101) CAR-T is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The NXC-201 CAR-T is provided fresh without cryopreservation.
Study Details
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).
Key Dates
- Start date
- Jun 5, 2024
- Status verified
- Jan 2025
- Primary completion
- Dec 31, 2026
- Completion
- Jan 31, 2039
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: NXC-201 CAR-TThe 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.
Primary Outcome Measure
Number of Participants With Treatment-Related Adverse Events [ Time Frame: 24 months ]
Central Contacts
- Nexcella310-773-0664
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Sutter Health Alta Bates | Berkeley | California | 94704 | Oleg Krijanovski, MD (PRINCIPAL_INVESTIGATOR) |
| City of Hope | Duarte | California | 91010 | Site Public Contact Michael A Rosenzweig, MD (PRINCIPAL_INVESTIGATOR) |
| University of California Los Angeles | Los Angeles | California | 90095 | Gary Schiller, MD (PRINCIPAL_INVESTIGATOR) |
| University of California Davis Medical Center | Sacramento | California | 95817 | Aaron Rosenberg, MD (PRINCIPAL_INVESTIGATOR) |
| Stanford University | Stanford | California | 94305 | Michaela Liedtke, MD (PRINCIPAL_INVESTIGATOR) |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | Jonathan Kaufman, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Kansas Cancer Center | Fairway | Kansas | 66205 | Jessie Lamphier Al-Ola Abdallah, MD (PRINCIPAL_INVESTIGATOR) |
| Boston University Medical Center | Boston | Massachusetts | 02118 | Vaishali Sanchorawala, MD (PRINCIPAL_INVESTIGATOR) |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Raymond Comenzo, MD (PRINCIPAL_INVESTIGATOR) |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | Jeffrey Zonder, MD (PRINCIPAL_INVESTIGATOR) |
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | Binoy Yohannan, MD (PRINCIPAL_INVESTIGATOR) |
| Washington University Siteman Cancer Center | St Louis | Missouri | 63110 | Keith Stockerl-Goldstein, MD (PRINCIPAL_INVESTIGATOR) |
| Memorial Sloan Kettering Comprehensive Cancer Center | New York | New York | 10065 | |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45267 | Ed Faber, DO (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Shahzad Raza, MD (PRINCIPAL_INVESTIGATOR) |
| Baptist Memorial Hospital | Memphis | Tennessee | 381202127 | Brion Randolph, MD (PRINCIPAL_INVESTIGATOR) |
| Huntsman Cancer Institute at the University of Utah | Salt Lake City | Utah | 84112 | Amandeep Godara, MD (PRINCIPAL_INVESTIGATOR) |
| Swedish Cancer Institute | Seattle | Washington | 98104 | Swathi Namburi, MD (PRINCIPAL_INVESTIGATOR) |