A Study of Fully Human BCMA CAR-T (CT103A) in Patients With Newly Diagnosed High-risk Multiple Myeloma (FUMANBA-2)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNanjing IASO Biotechnology Co., Ltd.

About this trial

This study is a multi-center, single-arm clinical study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamic characteristics of CT103A as the first-line treatment in newly diagnosed high-risk multiple myeloma subjects with induction chemotherapy as bridging therapy.

Eligibility criteria

Qualifiers

18 to 70 years old, male or female;

Revised Multiple Myeloma International Staging System (R-ISS) stage 3;

Double-hit or triple-hit according to FISH test.

The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;

Disqualifiers

Patient who needs chronic use of immunosuppressive agents;

Patient with hypertension that cannot be controlled by medication;

Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade III), severe arrhythmia;

Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases that require drug treatment;

Trial design

Treatments tested in this trial

  • Fully human BCMA chimeric antigen receptor autologous T cell injection (CT103A)

Treatment groups

20 Participants
are divided into 1 treatment group