NCT06067581

the Safety and Efficacy of SENL103 Autologous T Cell Injection

Clinical Study on the Safety and Efficacy of SENL103 Autologous T Cell Injection in the Treatment of Recurrent or Refractory Plasma Cell Blood Tumors

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe the safety and efficacy of SENL103 cells in the treatment of patients with recurrent or refractory plasma cell blood tumors.

Detailed description

Primary endpoint To observe the number and incidence of adverse events after intravenous infusion of SENL103. To evaluate possible adverse reactions recorded within 1 month after SENL103 infusion, including the number, incidence and severity of symptoms such as cytokine release syndrome and neurotoxic reactions; Secondary endpoints 1. Efficacy indicators: The efficacy after cell retransfusion was observed by strict complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD), and progression-free survival (PFS rate); 2. PK index: the highest concentration of SENL103 cells amplified in peripheral blood (Cmax, measured by flow cytometry and qPCR), the time to reach the highest concentration (Tmax) and the duration of cell survival in the patient; 3. PD index: proportion of peripheral blood plasma cells, concentration of free BCMA and cytokine release at each time point; 4. Quality of life assessment: the changes of subjects' quality of life before and after treatment were observed.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	SENL103	Patients will be treated with BCMA CAR-T cells

Timeline

• Start date: 2023-08-21
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2023-10-05
• Last updated: 2023-10-05

Locations

1 site across 1 country: China