Autologous CD19-CD20-NKG2D-nsBicephali CAR-T for Relapsed/Refractory Central Nervous System Lymphoma

StatusWithdrawn
PhasePhase 1
Started

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Record History

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  1. Trial status changed: Suspended → Withdrawn Show 5 more changesShow less
    • Enrollment target: estimated 30 to confirmed 0
    • Sponsor's reason: Enrollment temporarily suspended due to temporary operational limitations at the study site. to Due to the promulgation of State Council Order No. 818, this category of clinical trials is prohibited from conduct.
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 3 of 15 entries
    • Study description revised
  2. Recruitment suspended Sponsor's reason: Enrollment temporarily suspended due to temporary operational limitations at the study site.
    • Start date: Apr 2026 to Sep 2026
    • Site details revised
    v3
  3. Eligibility criteria shortened, about 22 words
    • Secondary endpoints: details revised at 6 of 15 entries
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Central nervous system lymphoma (CNSL) includes primary CNS lymphoma (PCNSL) and secondary CNS lymphoma (SCNSL), with diffuse large B-cell lymphoma as the predominant pathological type. Disease progression is often rapid and the relapse rate is high. Current standard treatment is centered on CNS-directed regimens based on high-dose methotrexate (HD-MTX), but salvage options for relapsed or refractory disease remain limited. In addition, the blood-brain barrier restricts effective exposure of many drugs within the central nervous system, making deep remission and durable disease control difficult to achieve. This study evaluates autologous CD19-CD20-NKG2D-nsBicephali CAR-T in patients with relapsed or refractory PCNSL or SCNSL. By engineering the patient's T cells into effector cells capable of recognizing both CD19 and CD20, this approach is intended to address tumor antigen heterogeneity and reduce immune escape associated with downregulation or loss of a single target. CAR-T cells may also migrate into cerebrospinal fluid and brain parenchyma, expand within the CNS compartment, and directly eliminate CD19/CD20-positive lymphoma cells. The study is designed to systematically evaluate the safety and preliminary efficacy of this investigational CAR-T therapy in relapsed or refractory CNSL.
Trial Details
NCT Number NCT07555561
Lead Sponsor Beijing Boren Hospital
Conditions
(from sponsor)		 Relapsed/Refractory Central Nervous System Lymphoma, Relapsed/Refractory Primary Central Nervous System Lymphoma, Relapsed/Refractory Secondary Central Nervous System Lymphoma
Related terms Recurrence
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov