Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Recurrence

Hematologic Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

This study will follow the classic "3+3" design and increase the dose according to three dose groups. Each dose group will have 3-6 eligible subjects selected according to the inclusion/exclusion criteria, with a dose of 1.0 × 10\^6, 2.0 × 10\^6, 3.0 × Increase the dose by 10\^6 CAR-T cells/kg.

Patients will be treated with BCMA CAR-T cells

SENL103

Chunrui Li

Chunrui Li, PhD&MD

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

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.

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

The number, incidence and severity of all recorded adverse reactions, including cytokine release syndrome and neurotoxicity.

To observe the efficacy of cell reperfusion, strict complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), disease stabilization (SD), disease-free progression-free survival (PFS rate), survival (OS) were adopted.

the proportion of BCMA+ plasma cells in peripheral blood, the concentration of free BCMA and the release of cytokines at each time point;

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;

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
the Safety and Efficacy of SENL103 Autologous T Cell Injection	NCT06067581	Multiple Myelom...	SENL103	18 Years - 75 Years	Hebei Senlang Biotechnology Inc., Ltd.
the Safety and Efficacy of SENL103 Autologous T Cell Injection	NCT06067581	Multiple Myelom...	SENL103	18 Years - 75 Years	Hebei Senlang Biotechnology Inc., Ltd.

Spots Global Cancer Trial Database for senl103

Every month we try and update this database with for senl103 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for senl103

Every month we try and update this database with for senl103 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for senl103 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.