Primary Light Chain (AL) AmyloidosisPhase 1/2NCT07765524
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
A Phase 1/2 study testing FKC289 infusion in people with Primary Light Chain (AL) Amyloidosis, run by Shenzhen Fosun Kairos Biotechnology Co., Ltd. at 11 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Light Chain (AL) Amyloidosis
- What is being tested?
- FKC289 infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 11 sitesChina
- Study dates
- Aug 2026to Sep 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- Presence of any clinically significant cardiovascular disease within 6 months prior to screening;
- Clinically significant central nervous system (CNS) disease or pathological abnormality;
- History of solid organ transplantation (e.g., heart, lung, kidney, liver);
- Presence of complete intestinal obstruction;
- Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;
- History of malignancy within 5 years prior to signing the ICF
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000
Xiaobin Huang, MD, +8618981838236, hxb_trial@163.com
West China Hospital Sichuan Hospital
Chengdu, Sichuan, 610000
Yu Wu, MD, +8618980601973, wuyulily@hotmail.com
The Frist Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510600
Liye Zhong, MD, +8613924200576, liye_zhong@hotmail.com
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510700
Zhongjun Xia, MD, +8613602713223, xiazj@sysuccorg.cn
The Second Affiliated Hospital Zhejiang University school of Medicine
Hangzhou, Zhejiang, 310009
Yang Xu, MD, +8615988132164, yxu@zju.edu.cn
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Hao Li, MD, +8618560086990, haoli611@163.com
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Xiaoyan Qu, MD, +8613770720898, quxiaoyan205@163.com
The Frist Affiliated Hospital of Guangxi Medical university
Nanning, Guangxi, 530021
Jun Luo, MD, +8613877179705, luojungz@medmial.com.cn
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Peng Liu, MD, +8613817692514, liu.peng@zs-hospital.sh.cn
Tongji Mecial college of HUST
Wuhan, Hubei, 430030
Chunrui Li, MD, +8613647233185, Cunrui5650@123.com
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Baijun Fang, MD, +8613526607830, fdation@126.com
About this study
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.
- Conditions
- Primary Light Chain (AL) Amyloidosis
- Being tested
- FKC289 infusion
- Keywords
- AL Amyloidosis, FKC289, BCMA/CD19, autologous chimeric antigen receptor T cells
- Medical subject headings
- Amyloidosis, Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FKC289 infusionDrug
Anti-BCMA/CD19 chimeric antigen receptor autologous T cells
| Study group | Role | What they receive |
|---|---|---|
| FKC289 injection | Experimental | Not described Receives: Drug: FKC289 infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
Number of subjects experiencing DLT
Measured: Within 28 days after FKC289 infusion
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of subjects experiencing AEs and SAEs
Measured: Within 24 months after FKC289 infusion
Replication Competent Lentivirus (RCL)
Number of subjects with positive detection of RCL
Measured: Within 24 months after FKC289 infusion
Secondary outcomes (4)
Hematologic complete response rate (CRR)
Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023
Measured: Within 6 months,12 months, and 24 months after FKC289 infusion
Hematologic objective response rate (ORR)
Proportion of subjects achieving hematologic objective response according to the NCCN 2023
Measured: Within 6 months,12 months, and 24 months after FKC289 infusion
Pharmacokinetics (PK)
Levels of CAR-T cells in peripheral blood
Measured: Within 24 months after FKC289 infusion
Pharmacodynamics (PD)
Proportion of CD19+ B cells and BCMA+ plasma cells in peripheral blood; Changes in the levels of cytokines in peripheral blood
Measured: Within 24 months after FKC289 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Light Chain (AL) AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Fosun Kairos Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765524
- Sponsor's protocol ID
- FKC289-2025-002
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07765524
- Acronym / sponsor ID
- FKC289-2025-002
- Conditions
- Primary Light Chain (AL) Amyloidosis
- Keywords
- AL Amyloidosis, FKC289, BCMA/CD19, autologous chimeric antigen receptor T cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shenzhen Fosun Kairos Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FKC289 injection | Experimental | Drug: FKC289 infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (6 listed)
- Presence of any clinically significant cardiovascular disease within 6 months prior to screening;
- Clinically significant central nervous system (CNS) disease or pathological abnormality;
- History of solid organ transplantation (e.g., heart, lung, kidney, liver);
- Presence of complete intestinal obstruction;
- Moderate to severe pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FKC289 infusionAnti-BCMA/CD19 chimeric antigen receptor autologous T cells | Drug | FKC289 injection |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: Within 28 days after FKC289 infusion
Number of subjects experiencing DLT
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Within 24 months after FKC289 infusion
Number of subjects experiencing AEs and SAEs
Replication Competent Lentivirus (RCL)
Time frame: Within 24 months after FKC289 infusion
Number of subjects with positive detection of RCL
4 secondary outcomes
Hematologic complete response rate (CRR)
Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion
Hematologic objective response rate (ORR)
Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion
Pharmacokinetics (PK)
Time frame: Within 24 months after FKC289 infusion
Pharmacodynamics (PD)
Time frame: Within 24 months after FKC289 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FKC289 infusion in people with Primary Light Chain (AL) Amyloidosis, run by Shenzhen Fosun Kairos Biotechnology Co., Ltd. at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhizhong Geng, MD (+8616601956551, eric.geng@fosunkairos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: Within 28 days after FKC289 infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.