Engineered immune cells take aim at a rare Protein-Folding disease
NCT ID NCT07765524
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This trial is testing an experimental treatment called FKC289 for people with primary AL amyloidosis that has relapsed or not responded to standard care. FKC289 uses a patient's own immune cells, engineered to recognize and attack the abnormal plasma cells that produce the harmful protein deposits. The study aims to assess the safety of this therapy and determine the best dose, as well as to see how effective it is at reducing signs of the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FKC289, a CAR-T cell therapy that targets BCMA and CD19 on plasma cells
- What this could lead to
- If successful, this could offer a new treatment option for people with AL amyloidosis that has returned or not responded to other therapies, potentially leading to remission.
- What could go wrong
- This is an early-stage trial with a small number of participants, so results may not be conclusive. CAR-T therapy carries risks like severe immune reactions and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
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Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
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Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510700, China
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The Frist Affiliated Hospital of Guangxi Medical university
Nanning, Guangxi, 530021, China
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The Frist Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510600, China
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The Second Affiliated Hospital Zhejiang University school of Medicine
Hangzhou, Zhejiang, 310009, China
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Tongji Mecial college of HUST
Wuhan, Hubei, 430030, China
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West China Hospital Sichuan Hospital
Chengdu, Sichuan, 610000, China
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Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China