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RPM CD19-mbIL15-CAR-T Cells in Patient With Advanced Lymphoid Malignancies

NCT04844086 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-05-18

No results posted yet for this study

Summary

This is an open-label Phase 1 study to determine the feasibility, safety, and the recommended maximum tolerated Dose (MTD) of a single infusion of RPM CD19 mbIL15 CAR-T cells for adult patients. Approximately 24 subjects will be enrolled and it is anticipated approximately 16 subjects will be infused at the varied doses of T cells.

Conditions

Interventions

BIOLOGICAL

RPM CD19-mbIL15-CAR-T cells

Single dose of RPM CD19-mbIL15-CAR-T cells will be infused, and a standard "3+3" design will be applied. Drug: Fludarabine Fludarabine is used for lymphodepletion. Drug: Cyclophosphamide Cyclophosphamide is used for lymphodepletion

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Eden BioCell Ltd.

    lead INDUSTRY

Principal Investigators

  • Shangru Wu, PhD · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2022-05-12
Completion
2022-05-12

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

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 NCT04844086 on ClinicalTrials.gov