OncoMatch/Clinical Trials/NCT07626476
Autologous BCMA-targeted CAR-T Cell Injection for Relapsed/Refractory Light Chain Amyloidosis
Is NCT07626476 recruiting? Yes, currently enrolling (Jul 2026). This Early Phase 1 trial studies Targeted BCMA Autologous CART Cell for relapsed/refractory light chain amyloidosis.
Treatment: Targeted BCMA Autologous CART Cell — Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs. The treatment goal is to reduce monoclonal immunoglobulin light-chain levels, prevent further amyloid deposition in important organs, and alleviate or reverse organ dysfunction caused by amyloid deposition. The principal approach to achieve this goal is to eliminate the plasma-cell or B-cell clones producing abnormal light chains. For patients with relapsed/refractory AL amyloidosis, the protocol states that there is currently no suitable treatment method and that participation in clinical trials is recommended. This study evaluates targeted BCMA autologous CART cell injection in participants with relapsed/refractory light chain amyloidosis. The main purpose is to evaluate safety, preliminarily verify efficacy, and explore in vivo pharmacokinetics, pharmacodynamics, immunogenicity and related characteristics after infusion.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Multiple Myeloma
Disease stage
Required: Stage I, II, IIIA
Excluded: Stage IIIB, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Relapsed/refractory light chain amyloidosis previously treated with 2 or more lines of therapy
Cannot have received: gene therapy
Prior gene therapy before enrollment
Lab requirements
Blood counts
Absolute neutrophil count ≥1.0×10^9/L (G-CSF support permitted); Platelet count ≥50×10^9/L; Hemoglobin ≥8 g/dL
Kidney function
Liver function
Bilirubin ≤1.5×ULN, except biliary obstruction caused by tumor compression; ALT or AST ≤2.5×ULN; for participants with liver involvement, ≤5×ULN
Cardiac function
Stable coagulation function: INR ≤1.5 and APTT ≤1.2×ULN, except tumor-related anticoagulant therapy; Baseline oxygen saturation on room air >92%
Adequate organ function before enrollment, meeting all of the following: Absolute neutrophil count ≥1.0×10^9/L; Platelet count ≥50×10^9/L; Hemoglobin ≥8 g/dL; Bilirubin ≤1.5×ULN, except biliary obstruction caused by tumor compression; ALT or AST ≤2.5×ULN; for participants with liver involvement, ≤5×ULN; Mayo 2004 stage I-IIIa; Stable coagulation function: INR ≤1.5 and APTT ≤1.2×ULN, except tumor-related anticoagulant therapy; Baseline oxygen saturation on room air >92%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07626476 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage I or II or IIIA is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages