RecruitingPhase 1NCT05528887

Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

Safety and Efficacy Study of Chimeric Antigen Receptor T (CAR-T) Cells in the Treatment of Relapsed/Refractory Hematological Malignancies

Sponsor

The Affiliated People's Hospital of Ningbo University

Enrollment

10 participants

Start Date

Sep 16, 2021

Study Type

INTERVENTIONAL

Conditions

Lymphoma Leukemia Myeloma Relapsed/Refractory Hematological Malignancies

Summary

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.
Positive expression of specific antigens.
Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
Adequate organ functions:
Serum bilirubin ≤ 35 μmol/L;
Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2;
Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);
Brain natriuretic peptide (BNP)\<80 pg/mL.
Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

Exclusion Criteria9

History of allergy to any of the drugs involved in the protocol.
History of cardiac diseases:
Left ventricular ejection fraction (LVEF) \< 50%;
Class III or IV heart failure as defined by the New York Heart Association (NYHA).
History of another malignancy tumor.
Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
Uncontrolled fungal, bacterial, viral, or other infection.
Female subjects who are pregnant or lactating.