A Phase 1/2 interventional study of FKC289 injection in Primary Membranous Nephropathy, sponsored by Shenzhen Fosun Kairos Biotechnology Co., Ltd.. Not yet recruiting at 8 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Shenzhen Fosun Kairos Biotechnology Co., Ltd. (part of Fosun Pharma) · Phase 1/2, Interventional, and Treatment
This Phase I study is designed to evaluate the safety and efficacy of FKC289 in subjects with relapsed/refractory Primary Membranous Nephropathy.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 achieving clinical response (including complete or partial response) at 6 months.
144 studies on the registry are indexed under Glomerulonephritis, Membranous; 58 are open to participants now.
This study's planned enrollment of 55 is above the median of 46 across 105 interventional studies indexed under Glomerulonephritis, Membranous.
Browse Glomerulonephritis, Membranous studies →Shenzhen Fosun Kairos Biotechnology Co., Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: FKC289 injection
Anti-BCMA/CD19 chimeric antigen receptor autologous T cells
Dose-Limiting Toxicity (DLT)
Number of subjects experiencing DLT
Time frame: Within 28 days after FKC289 infusion
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of subjects experiencing AEs and SAEs
Time frame: Within 24 months after FKC289 infusion
Replication Competent Lentivirus (RCL)
Number of subjects with positive detection of RCL
Time frame: Within 24 months after FKC289 infusion
Clinical response rate
Proportion of subjects achieving clinical response, including complete response (CR) and partial response (PR)
Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion
Clinical complete response rate
Proportion of subjects achieving clinical complete response
Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion
Immune response rate
Proportion of subjects achieving immune response
Time frame: Within 6 months,12 months, and 24 months after FKC289 infusion
Pharmacokinetics (PK)
Levels of CAR-T cells in peripheral blood
Time frame: Within 24 months after FKC289 infusion
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Sep 2028, 25 months later.
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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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Studies of the drug tested here: FKC289
Glomerulonephritis, Membranous →
Shenzhen Fosun Kairos Biotechnology Co., Ltd. →