CD19-CAR-T2 Cells for CD19 Positive B Cell Malignancies

Nanfang Hospital, Southern Medical University

Status and phase: Completed; Phase 2

Conditions: B Cell Leukemia; B Cell Lymphoma

Treatments: Biological: CD19-CAR-T2 Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04605666

NFEC-2020-098 (Other Identifier)

Details and patient eligibility

About

Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).

Enrollment: 77 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma
• Eastern Cooperative Oncology Group (ECOG) performance status <2
• ALT/ AST <3 x normal
• Bilirubin < 2.0 mg/dl
• Creatinine < 2.5 mg/dl and less than 2.5x normal for age
• LVEF< 45%
• Accept white blood cell collection
• Provide informed consent

Exclusion criteria

• Previous treatment with investigational gene or cell therapy medicine products
• Active hepatitis B , hepatitis C or HIV infection
• Uncontrolled active infection
• Presence of grade 2-4 acute or extensive chronic GVHD
• Any uncontrolled active medical disorder that would preclude participation as outlined.
• Received non-diagnostic purposes major surgery within the past 4 weeks
• Participated in any other clinical study within the past 4 weeks
• Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
• Pregnancy or breast-feeding women
• Use of prohibited drugs:
• Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion
• Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion
• GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion
• Any situation that may increase the risk of the test or interfere with the test results

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

CAR-T group

Experimental group

Treatment:

Biological: CD19-CAR-T2 Cells