← Back to Clinical Trials
Recruiting Phase 1 NCT05528887

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

Trial Parameters

Condition Relapsed/Refractory Hematological Malignancies
Sponsor The Affiliated People's Hospital of Ningbo University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-09-16
Completion 2024-06
Interventions
Autologous CAR-T cellsFludarabineCyclophosphamide

Brief 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 Criteria

Inclusion Criteria: 1. Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy. 2. Positive expression of specific antigens. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2. 4. 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. 5. 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 Criteria: 1. History of allergy to any of the drugs involved in the protocol. 2. 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). 3. History of another malignancy tumor.

Related Trials