A Clinical Study Assessing the Subcutaneous Formulation of TQB2934 for Injection in Subjects With Malignant Plasma Cell Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

TQB2934 is an anti-Cluster of Differentiation 3 (CD3) (Early T Cell Marker)×B cell maturation antigen (BCMA) double-specific antibody,and the isoform is IgG1(Native Immunoglobulin G1), which at one end binds to the CD3 receptor on the surface of T cells ,and the other end binds to BCMA(B cell maturation antigen) to recruit T cells around BCMA-positive cells, which can activate T cells .Active T cells release granzyme and perforin to kill BCMA-positive target cells.

TQB2934 for injection (subcutaneous injection) is intended for the treatment of patients with multiple myeloma.

Eligibility criteria

Qualifiers

The subjects voluntarily joined the study, signed an informed consent form, and had good compliance;

18 years old≤age≤75 years old (calculated based on the date of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG) score 0~2 points; expected survival is greater than 12 weeks;

Subjects with multiple myeloma must meet: 1) have a diagnostic record and meet the International Myeloma Working Group Relapsed (IMWG) diagnostic criteria; 2) there is a measurable lesion; 3) Refractory Multiple Myeloma (RRMM) has received at least one line of treatment, and at least one proteasome inhibitor (PI), an immunomodulator (IMiD) and a Cluster of Differentiation 38 (CD38) monoclonal antibody are refractory; 4) disease progression within 12 months after the last treatment or treatment;

Laboratory inspection standards that meet the program requirements;

Disqualifiers

Diagnosed with amyloidosis, active plasma cell leukemia (PCL, peripheral plasma cell proportion ≥5%, or absolute peripheral plasma cell count ≥0.5×109/L), Fahrenheit macroglobulinemia (WM) or POEMS syndrome and other plasma cell tumors;

Have received allogeneic hematopoietic stem cell transplantation within 1 year before the first medication, or have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks before the first medication;

Those who are known to have invasion of meninges or central nervous system or are highly suspected of invasion of meninges or central nervous system but cannot be identified;

Have received CD3×BCMA dual anti-anti-treatment in the past;

Trial design

Treatments tested in this trial

  • TQB2934 injection (subcutaneous injection)

Treatment groups

42 Participants
are divided into 1 treatment group