Neoplasms

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Multiple Myeloma

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Cyclophosphamide

Fludarabine

Fludarabine phosphate

Subjects will receive cell infusion, with the initial cell dose of 1E6/kg. 1-6 subjects will be enrolled. The second dose group was 3E6 cells /kg with 1-6 subjects; The third and fourth dose groups were 6E6 cells /kg and 1E7 cells /kg, respectively, with 3-6 subjects.

YTS104 Cell injection is a new STAR-T cell transfected by lentivirus.The study required that lymphocytes were collected from the subjects and cultured for 2-3 weeks to obtain YTS104 cell injection. Subjects were treated with fludarabine and cyclophosphamide chemotherapy prior to reinfusion, followed by a 2-day rest period before cell infusion.

YTS104 Cells injection

Gang An, Ph.D

Gang An

Lugui Qiu

This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of relapsed or refractory multiple myeloma subjects

This study will recruit LILRB4 positive multiple myeloma subjects,and Subjects should undergo FC chemotherapy before returning the cells, then followed by infusion of YTS104 cells injection. YTS104 cells injection will be intravenously infused with a escalated dose of 1E6#3E6#6E6#1E7 cells/kg.

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

An Exploratory Clinical Study on the Safety and Efficacy of YTS104 Cell Injection in the Treatment of Relapsed or Refractory Multiple Myeloma

Dose-limiting toxicity was defined as adverse events associated with YTS104-cell injection within 28 days of cell transfusion, including grade 4 or 5 CRS and ICANS; grade 4 haematological adverse events did not return to grade 2 or baseline within 28 days of cell transfusion

After YTS104-cell infusion, adverse events will be graded as CTCAE 5.0

DOR was defined as the time from the first documentation of response (PR or better) to the first documentation of disease progression or death from any cause after YTS104 infusion in patients with PR or better.

PFS was defined as the time between the subject's YTS104-cell infusion and the occurrence of disease progression or death from any cause.

It was defined as the time between the subject's reinfusion of YTS104 cell injection and death from any cause.

The proportion of STAR-T in peripheral blood was detected by flow cytometry,The copies of STAR-T DNA in peripheral blood was detected by qPCR method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma	NCT05913804	Relapsed or Ref...	YTS104 Cells in...	18 Years - 70 Years	Institute of Hematology & Blood Diseases Hospital, China
YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma	NCT05913804	Relapsed or Ref...	YTS104 Cells in...	18 Years - 70 Years	Institute of Hematology & Blood Diseases Hospital, China
YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma	NCT05913804	Relapsed or Ref...	YTS104 Cells in...	18 Years - 70 Years	Institute of Hematology & Blood Diseases Hospital, China

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