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

NCT ID: NCT04605666

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2023-12-31

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).

Conditions

B Cell Leukemia; B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR-T group

Group Type: EXPERIMENTAL

CD19-CAR-T2 Cells

Intervention Type: BIOLOGICAL

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

Interventions

CD19-CAR-T2 Cells

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qi-fa Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Countries

China

References

He B, Lin R, Xu N, Qin L, Wang Z, Wang Q, Li X, Wei X, Wei Y, Tang Z, Fan Z, Huang F, Liu X, Sun J, Xuan L, Li P, Zhou H, Liu Q. Efficacy and safety of third-generation CD19-CAR T cells incorporating CD28 and TLR2 intracellular domains for B-cell malignancies with central nervous system involvement: results of a pivotal trial. J Transl Med. 2025 May 27;23(1):594. doi: 10.1186/s12967-025-06608-x.

Reference Type: DERIVED

PMID: 40426201 (View on PubMed)

Other Identifiers

NFEC-2020-098

Identifier Type: OTHER

Identifier Source: secondary_id

NFEC-2020-098

Identifier Type: -

Identifier Source: org_study_id