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NOT YET RECRUITING
NCT07765524
PHASE1/PHASE2

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

Sponsor: Shenzhen Fosun Kairos Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-08

Completion Date

2029-09

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

DRUG

FKC289 infusion

Anti-BCMA/CD19 chimeric antigen receptor autologous T cells

Locations (11)

The Frist Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Frist Affiliated Hospital of Guangxi Medical university

Nanning, Guangxi, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Mecial college of HUST

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital Sichuan Hospital

Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University school of Medicine

Hangzhou, Zhejiang, China