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

NCT04732845 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-03

No results posted yet for this study

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).

Conditions

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

Sponsors & Collaborators

  • Benjamin Tomlinson

    lead OTHER

Principal Investigators

  • Benjamin Tomlinson, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-26
Primary Completion
2025-09-01
Completion
2039-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT04732845 on ClinicalTrials.gov