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NCT04605666

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

Completed Phase 2 Last updated 20 August 2024
What this trial tests

Phase 2 trial testing CD19-CAR-T2 Cells in B Cell Leukemia in 77 participants. Completed in 31 December 2023.

Timeline
1 May 2020
Primary endpoint
30 June 2023
31 December 2023

Quick facts

Lead sponsorNanfang Hospital, Southern Medical University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment77
Start date1 May 2020
Primary completion30 June 2023
Estimated completion31 December 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Nanfang Hospital, Southern Medical University

Who can join

Adults 18 to 85, any sex, with B Cell Leukemia or B Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. T-cells engineered with a novel VHH-based chimeric antigen receptor against CD19 exhibit comparable tumoricidal efficacy to their FMC63-based counterparts.
    Nasiri F, Safarzadeh Kozani P, Rahbarizadeh F. · · 2023 · cited 29× · PMID 36875091 · DOI 10.3389/fimmu.2023.1063838
  2. 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.
    He B, Lin R, Xu N, Qin L, et al · · 2025 · cited 7× · PMID 40426201 · DOI 10.1186/s12967-025-06608-x

Verify or expand the search:

Other recruiting trials for B Cell Leukemia

Currently open trials in the same condition.

Other Nanfang Hospital, Southern Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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