Not Yet RecruitingPhase 1/2

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

China32 participantsStarted 2026-08

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dose-Limiting Toxicity (DLT)

Timeframe: Within 28 days after FKC289 infusion

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: Within 24 months after FKC289 infusion

Replication Competent Lentivirus (RCL)

Timeframe: Within 24 months after FKC289 infusion

Trial details

NCT IDNCT07765524

SponsorShenzhen Fosun Kairos Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Zhizhong Geng, MD

+8616601956551 eric.geng@fosunkairos.com

View on ClinicalTrials.gov More Primary Light Chain (AL) Amyloidosis trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria