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ACTIVE NOT RECRUITING
NCT04732845
PHASE1

Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies

Sponsor: Benjamin Tomlinson

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if it is possible to treat relapsed or refractory lymphoid malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia) with a new type of T cell-based immunotherapy (therapy that uses the immune system to treat the cancer).

Official title: Phase I Clinical Trial of Human AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies (Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2021-04-26

Completion Date

2039-12-01

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

BIOLOGICAL

Fully human anti CD19 CAR-T Cell Dose

Level -1 (1 x 10\^5 cells/kg) Level 1 \[Starting Dose\] (5 x 10\^5 cells/kg) Level 2 (1 x 10\^6 cells/kg) Level 3 (2 x 10\^6 cells/kg) Infusion of CAR-T cells will occur over 5-30 minutes.

DRUG

Fludarabine

25 mg/m2 daily from day -5 to -3

DRUG

Cyclophosphamide

60mg/Kg on day -6

Locations (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States