YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- YTS104 Cells injection
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov