Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD19 CARvac in Patients With Relapsed and/or Refractory B Cell Malignancies

iCell Gene Therapeutics2 sites in 1 country20 target enrollmentFebruary 1, 2018

ConditionsB Cell Lymphoma B Cell Leukemia

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: B Cell Lymphoma
Sponsor: iCell Gene Therapeutics
Enrollment: 20
Locations: 2
Primary Endpoint: Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.

Detailed Description

CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat

Registry

clinicaltrials.gov

Start Date

February 1, 2018

End Date

February 28, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

iCell Gene Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis based on the World Health Organization (WHO) 2008
•Patients have exhausted standard therapeutic options
•Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
•Female must be not pregnant during the study

Exclusion Criteria

•Prior solid organ transplantation
•Potentially curative therapy including chemotherapy or hematopoietic cell transplant
•Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents

Outcomes

Primary Outcomes

Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time Frame: 2 years

Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time Frame: 28 days

Type of dose-limiting toxicity (DLT)

Time Frame: 28 days