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Not yet recruitingNCT07765524Updated Aug 14, 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

A Phase 1/2 interventional study of FKC289 infusion in Primary Light Chain (AL) Amyloidosis, sponsored by Shenzhen Fosun Kairos Biotechnology Co., Ltd.. Not yet recruiting at 11 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Primary conditionImmunoglobulin Light-chain AmyloidosisRegistry: AmyloidosisReclassifiedWhy we changed it
Registry
Amyloidosis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Immunoglobulin Light-chain Amyloidosis
Why
  1. The study's title name Immunoglobulin Light-chain Amyloidosis, a narrower term within Amyloidosis.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Shenzhen Fosun Kairos Biotechnology Co., Ltd. (part of Fosun Pharma) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Light Chain (AL) Amyloidosis

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Keywords

  • AL Amyloidosis
  • FKC289
  • BCMA/CD19
  • autologous chimeric antigen receptor T cells
03

In context

Immunoglobulin Light-chain Amyloidosis Reclassified

239 studies on the registry are indexed under Immunoglobulin Light-chain Amyloidosis; 63 are open to participants now.

This study's planned enrollment of 32 is below the median of 39 across 169 interventional studies indexed under Immunoglobulin Light-chain Amyloidosis.

Browse Immunoglobulin Light-chain Amyloidosis studies →

Lead sponsor

Shenzhen Fosun Kairos Biotechnology Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Browse Shenzhen Fosun Kairos Biotechnology Co., Ltd. studies →All Fosun Pharma studies →

Compared within Immunoglobulin Light-chain Amyloidosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Amyloidosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily signed the form (ICF);
  2. Aged between 18-75 years old (inclusive);
  3. Confirmed clinical diagnosis of primary light chain (AL) amyloidosis;
  4. disease;
  5. dFLC ≥ 40 mg/L (based on central laboratory test results);
  6. 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

Exclusion Criteria:

  1. Presence of any 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 within 5 years prior to signing the ICF
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    FKC289 injection

    Drug: FKC289 infusion

Interventions

  • DrugFKC289 infusion

    Anti-BCMA/CD19 chimeric antigen receptor autologous T cells

06

What researchers measure

Primary outcomes

  1. Dose-Limiting Toxicity (DLT)

    Number of subjects experiencing DLT

    Time frame: Within 28 days after FKC289 infusion

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

    Number of subjects experiencing AEs and SAEs

    Time frame: Within 24 months after FKC289 infusion

  3. Replication Competent Lentivirus (RCL)

    Number of subjects with positive detection of RCL

    Time frame: Within 24 months after FKC289 infusion

Secondary outcomes

  1. Hematologic complete response rate (CRR)

    Proportion of subjects achieving hematologic complete response (CR) according to the NCCN 2023

    Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion

  2. Hematologic objective response rate (ORR)

    Proportion of subjects achieving hematologic objective response according to the NCCN 2023

    Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion

  3. Pharmacokinetics (PK)

    Levels of CAR-T cells in peripheral blood

    Time frame: Within 24 months after FKC289 infusion

  4. Pharmacodynamics (PD)

    Proportion of CD19+ B cells and BCMA+ plasma cells in peripheral blood; Changes in the levels of cytokines in peripheral blood

    Time frame: Within 24 months after FKC289 infusion

07

Study locations

11 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Mar 2028, 19 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2026
First posted
Aug 14, 2026
StartEst.
Aug 2026
Primary completionEst.
Mar 2028
CompletionEst.
Sep 2029
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07765524
Lead sponsor
Shenzhen Fosun Kairos Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Aug 14, 2026
Start date
Aug 2026 (estimated)
Primary completion
Mar 2028 (estimated)
Completion
Sep 2029 (estimated)
Last update
Aug 14, 2026

Study contacts

Zhizhong Geng, MD
Contact
eric.geng@fosunkairos.com
+8616601956551
Jing Li, MD
Contact
li.jing6@zs-hospital.sh.cn
+8621-64041990 ext. 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: FKC289

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Immunoglobulin Light-chain Amyloidosis →

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Shenzhen Fosun Kairos Biotechnology Co., Ltd. →

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