ClinicalTrials.gov record NCT07765524

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old to 75 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase I/II treatment study tests FKC289, an autologous anti-BCMA/CD19 CAR‑T cell infusion, in people with relapsed or refractory primary light chain (AL) amyloidosis. Phase I will assess safety and establish a recommended Phase II dose (RP2D). Phase II will assess the proportion of participants who achieve a hematologic complete response within 6 months. Safety and response measures will be followed for up to 24 months after infusion.

What it is studying. The study is testing whether FKC289 can be given safely to people with relapsed/refractory primary AL amyloidosis, what dose should be used (RP2D), and how many participants reach a hematologic complete response within 6 months. It also measures dose-limiting toxicities, adverse events, replication-competent lentivirus, levels of CAR‑T cells, and blood immune markers over follow-up.

What the researchers hope to learn. Scientific goals are to assess safety and dose-limiting toxicities, establish a recommended Phase II dose (RP2D), and measure the proportion of participants achieving hematologic complete response within 6 months. The study will also record adverse events, test for replication-competent lentivirus, and collect pharmacokinetic and pharmacodynamic data up to 24 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • FKC289 infusion

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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);

Exclusion criteria

  • 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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If you join, your own T cells will be collected by leukapheresis and used to manufacture the study product (FKC289), which is then given back as an infusion. After infusion you will attend regular follow-up visits with blood tests to monitor safety, measure levels of the CAR‑T cells in blood, and check immune markers such as CD19+ B cells, BCMA+ plasma cells, and cytokine levels, as well as to assess hematologic response. Safety monitoring specifically includes checking for dose‑limiting toxicities within 28 days, tracking adverse events and serious adverse events, and testing for replication competent lentivirus, with assessments reported up to 24 months after infusion. The study will require multiple clinic visits and blood draws; the study team will provide the exact visit schedule and details of any additional procedures.

How the study is structured. This is an open-label, single-arm Phase I then Phase II interventional study (no masking, no randomization). Participants receive FKC289 infusion (anti-BCMA/CD19 autologous CAR‑T cells) and are followed for safety and response assessments. Phase I focuses on safety and dose-finding; Phase II evaluates hematologic response rates. Key outcomes are tracked up to 24 months after infusion.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
August 2026 (estimated)
Primary completion
March 2028 (estimated)
Study completion
September 2029 (estimated)
Target enrollment
32 participants (estimated)
Last updated on registry
Aug 14, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Shenzhen Fosun Kairos Biotechnology Co., Ltd.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (11)

Terms used on this page · explanations by MedicalUpdates.ai

Phase I
An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
Phase II
A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
RP2D
The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.
complete response
No sign of the condition can be found with the tests used in the study. It does not always mean the condition is gone permanently, and the definition depends on the condition and the study.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
dFLC
The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
ECOG performance status
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
prior to screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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