CAR-T Cells in the Treatment of Malignant Hematological Tumors

Multiple Myeloma Clinical Trial

Official title:

Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05619861
• Other study ID #: 2022/11/09
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: December 26, 2023

Study information

• Verified date: November 2022
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Description:

Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 26, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

1. With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor

2. Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis;

3. Age 14-70 (including boundary value), both male and female;

4. Subjects with a physical status of 0~2 in the American Eastern Oncology Collaboration Group (ECOG);

5. The results of treatment related antigens were positive;

6. The expected life span is more than 3 months from the date of signing the informed consent;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, B-Cell
• Leukemia, T-Cell
• Lymphoma, B-Cell
• Multiple Myeloma

Intervention

Biological:
• CAR-T
Patients will receive CAR-T treatment

Locations

Country	Name	City	State
China	Cangzhou People's Hospital	Cangzhou	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.	Cangzhou People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence and severity of adverse events	The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period	24 months post CAR-T cells infusion