Last reviewed · How we verify
Exploratory Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T-cell Injection (Equecabtagene Autoleucel, Eque-cel) for the Treatment of Newly Diagnosed Mayo Stage IIIb AL Amyloidosis Patients
The goal of this clinical trial is to learn if Equecabtagene Autoleucel(Eque-cel), a Chimeric Antigen Receptor T-cell (CAR-T) therapy, works to treat severe Light Chain (AL) Amyloidosis in newly diagnosed adults with Mayo Stage IIIb. It will also learn about the safety and effects of Eque-cel. The main questions it aims to answer are: Does Eque-cel lead to hematologic remission (achieving a very good partial response or better) in AL amyloidosis? How safe is Eque-cel for these patients, and what side effects might occur? Participants will: Undergo blood cell collection to create personalized Eque-cel therapy. Receive pre-treatment to prepare their body for the therapy (lymphodepletion). Receive a single infusion of Eque-cel. Be monitored closely for 24 weeks after infusion, followed by long-term checkups for up to 15 years.
Details
| Lead sponsor | Nanjing IASO Biotechnology Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 17 |
| Start date | 2025-07 |
| Completion | 2027-06 |
Conditions
- AL Amyloidosis
Interventions
- Eque-cel CAR-T Therapy
Primary outcomes
- Proportion of Patients Achieving Hematologic VGPR or Better by Day 90 — From Eque-cel infusion to Day 90 post-infusion
This measure assesses the effectiveness of Eque-cel CAR-T therapy by calculating the percentage of patients who achieve a Very Good Partial Response (VGPR) or better within 90 days post-infusion. Hematologic response indicates a significant reduction in AL amyloidosis blood markers, like abnormal light chains, based on international consensus guidelines. Blood samples are tested at Day 90 using lab methods such as serum free light chain (FLC) and protein electrophoresis (SPEP) to confirm VGPR, reflecting disease control in Mayo Stage IIIb patients.