A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Primary AL Amyloidosis

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07765524

Enrollment

Registered

2026-08-14

Start date

2026-08-01

Completion date

2029-09-01

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Light Chain (AL) Amyloidosis

Keywords

AL Amyloidosis, FKC289, BCMA/CD19, autologous chimeric antigen receptor T cells

Brief summary

This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed/refractory primary light chain (AL) amyloidosis.The primary objectives are to assess the safety of FKC289 and to establish the recommended Phase II dose (RP2D). And this Phase II study is designed to evaluate the efficacy of FKC289.The primary objectives are to assess proportion of subjects with hematologically best complete response (CR) within 6 months.

Interventions

DRUGFKC289 infusion

Anti-BCMA/CD19 chimeric antigen receptor autologous T cells

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Voluntarily signed the informed consent form (ICF); 2. Aged between 18-75 years old (inclusive); 3. Confirmed clinical diagnosis of primary light chain (AL) amyloidosis; 4. Relapsed or refractory disease; 5. dFLC ≥ 40 mg/L (based on central laboratory test results); 6. ECOG performance status of 0 to 2; 7. No active systemic infection within 2 weeks prior to leukapheresis; 8. Adequate bone marrow and major organ function (including hepatic, renal, cardiac, and pulmonary);

Exclusion criteria

1. Presence of any clinically significant cardiovascular disease within 6 months prior to screening; 2. Clinically significant central nervous system (CNS) disease or pathological abnormality; 3. History of solid organ transplantation (e.g., heart, lung, kidney, liver); 4. Presence of complete intestinal obstruction; 5. Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage; 6. History of malignancy within 5 years prior to signing the ICF

Design outcomes

Primary

Measure	Time frame	Description
Dose-Limiting Toxicity (DLT)	Within 28 days after FKC289 infusion	Number of subjects experiencing DLT
Adverse Events (AEs) and Serious Adverse Events (SAEs)	Within 24 months after FKC289 infusion	Number of subjects experiencing AEs and SAEs
Replication Competent Lentivirus (RCL)	Within 24 months after FKC289 infusion	Number of subjects with positive detection of RCL

Secondary

Measure	Time frame	Description
Hematologic complete response rate (CRR)	Within 6 months,12 months, and 24 months after FKC289 infusion	Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023
Hematologic objective response rate (ORR)	Within 6 months,12 months, and 24 months after FKC289 infusion	Proportion of subjects achieving hematologic objective response according to the NCCN 2023
Pharmacokinetics (PK)	Within 24 months after FKC289 infusion	Levels of CAR-T cells in peripheral blood
Pharmacodynamics (PD)	Within 24 months after FKC289 infusion	Proportion of CD19+ B cells and BCMA+ plasma cells in peripheral blood; Changes in the levels of cytokines in peripheral blood

Countries

China

Contacts

CONTACTZhizhong Geng, MD

eric.geng@fosunkairos.com+8616601956551

CONTACTJing Li, MD

li.jing6@zs-hospital.sh.cn+8621-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026