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FKC289

Phase 1

Primary Membranous Nephropathy | Small molecule | Nephrology |Kairos Pharma, Ltd.|Last Updated: Aug 14, 2026

Target and mechanism

ModalitySmall molecule

Also known as FKC289 injection

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

FKC289 · 1 trial · 1 indication

Phase 1 1
NCT07765537A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Membranous NephropathyPrimary Membranous Nephropathy
NOT YET_RECRUITING55 Analytics
PHASE1NOT YET_RECRUITING
A Phase I/II Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Efficacy of FKC289 in Subjects With Relapsed/Refractory Membranous Nephropathy
Primary Membranous NephropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose-Limiting Toxicity (DLT)
Within 28 days after FKC289 infusion

Number of subjects experiencing DLT

Adverse Events (AEs) and Serious Adverse Events (SAEs)
Within 24 months after FKC289 infusion

Number of subjects experiencing AEs and SAEs

Replication Competent Lentivirus (RCL)
Within 24 months after FKC289 infusion

Number of subjects with positive detection of RCL

Secondary Endpoints

Clinical response rate
Within 6 months,12 months, and 24 months after FKC289 infusion
Clinical complete response rate
Within 6 months,12 months, and 24 months after FKC289 infusion
Immune response rate
Within 6 months,12 months, and 24 months after FKC289 infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FKC289 injectionEXPERIMENTAL -

Interventions

NameTypeDescription
FKC289 injectionDRUGAnti-BCMA/CD19 chimeric antigen receptor autologous T cells
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: 1. Voluntarily signed the informed consent form (ICF); 2. Aged between 18-70 years old (inclusive); 3. Histologically confirmed diagnosis of primary membranous nephropathy by renal biopsy obtained within the past 2 years.; 4. Relapsed or refractory disease; 5. Anti-PLA2R antibod...

Countries:China
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Frequently asked questions about FKC289

What is FKC289 used for?

FKC289 is an investigational small molecule being developed for the treatment of Primary Membranous Nephropathy, a kidney disease. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes FKC289?

FKC289 is being developed by Kairos Pharma, Ltd., a biopharmaceutical company listed on the stock exchange under the ticker symbol KAPA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is FKC289 in?

FKC289 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The ongoing trial is a Phase I/II open-label, single-arm, multicenter study designed to evaluate its safety and efficacy.

What clinical trials is FKC289 in?

FKC289 is being studied in a Phase I/II clinical trial with the identifier NCT07765537. This open-label, single-arm, multicenter study is enrolling 55 participants with relapsed or refractory Primary Membranous Nephropathy in China. The trial is not yet recruiting participants.

Is FKC289 the same as FKC289 injection?

Yes, FKC289 is also known as FKC289 injection. Both names refer to the same investigational drug being developed by Kairos Pharma, Ltd. for the treatment of Primary Membranous Nephropathy.