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FKC289 infusion

Phase 1

Primary Light Chain (AL) Amyloidosis | Small molecule | Other |Kairos Pharma, Ltd.|Last Updated: Aug 14, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

FKC289 infusion · 1 trial · 1 indication

Phase 1 1
NCT07765524A 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 AmyloidosisPrimary Light Chain (AL) Amyloidosis
NOT YET_RECRUITING32 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 Primary AL Amyloidosis
Primary Light Chain (AL) AmyloidosisUnlock 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

Hematologic complete response rate (CRR)
Within 6 months,12 months, and 24 months after FKC289 infusion
Hematologic objective response rate (ORR)
Within 6 months,12 months, and 24 months after FKC289 infusion
Pharmacokinetics (PK)
Within 24 months after FKC289 infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FKC289 injectionEXPERIMENTAL -

Interventions

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

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites11

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 p...

Countries:China
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Frequently asked questions about FKC289 infusion

What is FKC289 infusion used for?

FKC289 infusion is an investigational small molecule being studied for the treatment of relapsed or refractory Primary Light Chain (AL) Amyloidosis. It is currently in Phase 1 clinical development and has not been approved by any regulatory authority.

Who is developing FKC289 infusion?

FKC289 infusion is being developed by Kairos Pharma, Ltd., a 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 infusion in?

FKC289 infusion is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and effectiveness in patients.

What clinical trials is FKC289 infusion in?

FKC289 infusion is being studied in a Phase 1/II open-label, single-arm, multicenter clinical trial with the identifier NCT07765524. This trial is evaluating the drug in subjects with relapsed or refractory Primary AL Amyloidosis and is expected to enroll 32 participants in China.

Is FKC289 infusion the same as any other drug?

FKC289 infusion is a distinct investigational drug candidate. No alternative names for this drug have been disclosed in the available clinical trial information. It is being studied under its own name in the ongoing clinical development program.