CD19-CAR-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia, in Relapse Clinical Trial

Official title:

CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04605666
• Other study ID #: CAR-T-ALL-2020
• Secondary ID: NFEC-2020-098
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: Ren Lin, MD
• Phone: +86-020-62787883
• Email: lansinglinren[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Relapsed and refractory B cell acute lymphoblastic leukemia (B-ALL) shows unfavorable prognosis, especially for adult patients. Besides, minimal residual disease (MRD) positive at transplant has been considered risk factor for relapse after transplantation. Worse yet, there is no standard management for these patients. 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 chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with CD19+ ALL.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient with CD19 positive B-cell acute leukemia
• 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
• Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
• Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
• 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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia Not Having Achieved Remission
• Acute Lymphoblastic Leukemia, Adult
• Acute Lymphoblastic Leukemia, in Relapse
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• CD19-CAR-T2 Cells
CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	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.	3 months
Secondary	ORR		6 months
Secondary	ORR		12 months
Secondary	Adverse Events		12 months
Secondary	OS	overall survival	1 year
Secondary	DFS	disease-free survival	1 year