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FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

NCT05978661 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-11-15

No results posted yet for this study

Summary

This study is a single-center exploratory clinical trial. It is estimated that 6-12 subjects will be enrolled. The "BOIN" dose escalation design is adopted. The main purpose is to evaluate the safety of FKC288 in the treatment of subjects with relapsed or refractory AL amyloidosis and explore the recommended phase II dose of FKC288 in the treatment of patients with relapsed/refractory systemic Light Chain (AL) amyloidosis.

Conditions

  • Light Chain Amyloidosis

Interventions

DRUG

FKC288

Administration of FKC288 Four dose groups of 0.1×10\^6 CAR-T/kg, 0.3×10\^6 CAR-T/kg, 1.0×10\^6 CAR-T/kg, and 3.0×10\^6 CAR-T/kg FKC288 are designed in this study. 3 to 6 subjects are expected to be enrolled in each dose group according to observed DLT.

Sponsors & Collaborators

  • Nanjing University School of Medicine

    lead OTHER

Principal Investigators

  • Xianghua Huang, MD · Jinling Hospital, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978661 on ClinicalTrials.gov