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

Phase 2

Completed

• Conditions: B Cell Leukemia; B Cell Lymphoma
• Interventions: Biological: CD19-CAR-T2 Cells

• Registration Number: NCT04605666
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-10-25
• Study First Submitted QC: 2020-10-25
• Study First Posted: 2020-10-28
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T group	CD19-CAR-T2 Cells	-

Primary Outcome Measures

Name	Time	Method
ORR	3 months	Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.

Secondary Outcome Measures

Name	Time	Method
OS	1 year	overall survival
DFS	1 year	disease-free survival
ORR	12 months
Adverse Events	12 months

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China