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ET190L1-ARTEMIS™ T Cells in Relapsed, Refractory B Cell Leukemia and Lymphoma

NCT03895944 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-03-29

No results posted yet for this study

Summary

Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma

Conditions

  • CD19+ Lymphoma, B-Cell
  • CD19+ Leukemia, B-Cell

Interventions

BIOLOGICAL

ET190L1-ARTEMIS™ T cells -iv low dose

Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 1x10\^6

BIOLOGICAL

ET190L1-ARTEMIS™ T cells -iv middle dose

Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 3x10\^6

BIOLOGICAL

ET190L1-ARTEMIS™ T cells - iv high dose

Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 10x10\^6

Sponsors & Collaborators

  • Eureka Therapeutics Inc.

    collaborator INDUSTRY

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Mei Zhang, PhD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-06
Primary Completion
2019-12-06
Completion
2019-12-06
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

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 NCT03895944 on ClinicalTrials.gov