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

NCT05913804 | Recruiting Phase 1

• 1 other identifier: IIT2023020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Number of Patients with Dose Limiting Toxicity

  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

  Within 28 days after cell transfusion

• Incidence and severity of adverse events

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

  24 months

Secondary Outcomes (5)

• Overall response rate (ORR)

  24 months

• Duration OF RESPONSE(DOR)

  24 months

• Progression-free survival(PFS)

  24 months

• Overall survival(OS)

  24 months

• Expansion and persistence of YTS104 cell injection in vivo

  24 months

Study Arms (1)

YTS104 cells injection

EXPERIMENTAL

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.Subjects may undergo secondary or multiple retransfusion

Biological: YTS104 Cells injection

Interventions

YTS104 Cells injection BIOLOGICAL

YTS104 Cell injection(LILRB4 dual STAR-T Cell Injection/BCMA LILRB4 Dual STAR-T 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years, gender is not limited;
• Patients diagnosed as relapsed/refractory multiple myeloma according to the International Myeloma Working Group (IMWG 2014) criteria for multiple myeloma after at least 3 lines of treatment (including at least one proteasome inhibitor and an immunomodulator based chemotherapy regimen), and at least one complete treatment cycle per line of treatment; Documented disease progression during or within 12 months after the most recent antimyeloma therapy (not limited to 12 months after CAR-T therapy as the last line of therapy);
• The presence of one or more measurable lesions at screening was defined as any of the following: 1) serum M-protein ≥0.5g/dL (≥5g/L), 2) urinary M-protein level ≥200 mg/24 hours; 3) serum free light chain (sFLC) ≥100 mg/L and serum κ/λ free light chain ratio abnormal (\<0.26 or \>1.65);
• Good organ function;
• ECOG score ≤1;
• The predicted survival time was ≥12 weeks;
• Female subjects of childbearing age or male subjects with partners of women of childbearing age agreed to use effective methods of contraception throughout the trial and for 12 months after cell infusion;
• The subjects voluntarily participated in the study, signed the informed consent form, and complied with the follow-up.

You may not qualify if:

• A history of allergy to any component of the cell product;
• Patients who had used CAR-T cell therapy or any other gene transduction or other therapeutic products within 3 months after signing the informed consent, except those with undetectable CAR-T cells or CAR-T cells below the lower limit of detection;
• Subjects had plasma cell leukemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis;
• Patients with a history of any of the following cardiovascular and cerebrovascular diseases within the preceding 6 months were screened;
• Congestive heart failure (New York Heart Association \[NYHA\]≥III), congenital long QT syndrome, left front half block (double bundle block), asymptomatic right bundle branch block allowed; Myocardial infarction, unstable angina pectoris, coronary angioplasty, stent implantation, coronary/peripheral artery bypass grafting;
• Cerebrovascular accident (CVA) and transient ischemic attack (TIA);
• Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, etc.); d: Subjects had uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg), a history of hypertensive crisis, or hypertensive encephalopathy;
• Pulmonary embolism, or deep venous thrombosis of the lower extremity requiring anticoagulation, or active lung disease and/or pneumonia have occurred within 6 months prior to screening;
• Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) and HBV DNA in peripheral blood were positive. Hepatitis C virus (HCV) antibody positive and HCV RNA positive; Treponema pallidum antibody was positive;
• Patients with known systemic lupus erythematosus, co-active or uncontrolled autoimmune diseases (e.g., Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (e.g., HIV infection or severe infectious diseases);
• Patients with previous or concurrent uncured malignant tumors with unstable control, affecting the long-term survival of the subjects, excluding cured cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or other malignant tumors with local prostate cancer after radical treatment, ductal carcinoma in situ after radical treatment and no recurrence for at least 5 years;
• Patients with current or previous history of central nervous system disease, such as seizures, stroke, severe brain injury, aphasia, paralysis, dementia, Parkinson's disease, mental illness, etc.;
• Have central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial neuropathy and extensive lesions or spinal cord compression);
• Patients had undergone previous solid-organ transplantation or allogeneic hematopoietic stem-cell transplantation (allo-HSCT) 6 months before screening or autologous stem-cell transplantation within 3 months before apheresis;
• Patients with acute or chronic graft-versus-host disease (GVHD) at screening time;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• China Immunotech (Beijing) Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Gang An

  Institute of Hematology & Blood Diseases Hospital Ethics Committee

  STUDY DIRECTOR

• Lugui Qiu

  Institute of Hematology & Blood Diseases Hospital Ethics Committee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang An, Ph.D

CONTACT

13502181109; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 22, 2023
• Study Start: June 28, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 15, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)