CAR-T Cells in the Treatment of Malignant Hematological Tumors

NCT05619861 | Unknown

• 1 other identifier: 2022/11/09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoma, B-Cell; Leukemia, B-cell; Leukemia, T-Cell; Multiple Myeloma

Keywords

T cells

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

CAR-T

EXPERIMENTAL

Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg

Biological: CAR-T

Interventions

CAR-T BIOLOGICAL

Patients will receive CAR-T treatment

CAR-T

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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;

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• Cangzhou People's Hospital: collaborator

Study Sites (1)

Cangzhou People's Hospital

Cangzhou, Hebei, China

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: April 27, 2020
• Primary Completion: January 26, 2023
• Study Completion: December 26, 2023
• Last Updated: November 17, 2022

Record last verified: 2022-11

Locations

CN (1)