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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. your organs (liver, kidneys, etc.) are working well enough based on blood testss: - 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 willing to sign a consent form, and be able to comply with the study and follow-up procedures. Who Should NOT Join This Trial: 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. 4. Active hepatitis C (HCV), hepatitis B (HBV), human weakened immune system virus (HIV), or syphilis infection. 5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation. 6. Uncontrolled fungal, bacterial, viral, or other infection. 7. Female subjects who are pregnant or lactating. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. 4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection. 5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation. 6. Uncontrolled fungal, bacterial, viral, or other infection. 7. Female subjects who are pregnant or lactating.

Treatments Being Tested

BIOLOGICAL

Autologous CAR-T cells

D0: CAR-T cells will be infused intravenously.

DRUG

Fludarabine

D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.

DRUG

Cyclophosphamide

D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.

Locations (1)

The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China