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Safety of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells in Adult Patients With Diffuse Large B-cell Lymphoma

NCT04215016 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-01-02

No results posted yet for this study

Summary

This is a single-arm, open-label, dose escalation, phase I study, aiming to evaluate the safety and efficacy of Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific Chimeric Antigen Receptor (CAR) T-cells in patient with relapsed or refractory diffuse B cell lymphoma.

Conditions

  • Relapsed or Refractory DLBCL Patients With Either CD19 or CD20 Positive

Interventions

BIOLOGICAL

Autologous humanized anti-CD19 and anti-CD20 dual specific CAR-T Cells

Humanized anti-CD19 and CD20 bispecific autologous CAR-T cells injection: the first dose is 1.0×106 /kg, the second dose is 3.0×106 /kg, and the third dose is 8.0×106 /kg. Patients will receive lymphodepleting chemotherapy at least 1 week before CAR-T cell infusion.

Sponsors & Collaborators

  • Fujian Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04215016 on ClinicalTrials.gov