Health TrialsbyHealthPanel

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

ConditionRelapsed 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • YTS104 Cells injection

    Biological/Vaccine

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: YTS104 cells injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Within 28 days after cell transfusion
2

Incidence and severity of adverse events

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

Time frame
24 months

Secondary outcomes

1

Overall response rate (ORR)

Including sCR, CR, VGPR, and PR.

Time frame
24 months
2

Duration OF RESPONSE(DOR)

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.

Time frame
24 months
3

Progression-free survival(PFS)

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

Time frame
24 months
4

Overall survival(OS)

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

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

China Immunotech (Beijing) Biotechnology Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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