CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies

iCell Gene Therapeutics

Status and phase: Unknown; Early Phase 1

Conditions: B Cell Leukemia; B Cell Lymphoma

Treatments: Biological: CD19 CARvac T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04156243

ICG134-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Prior solid organ transplantation
2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CD19 CARvac T cells

Experimental group

Description:

CD19 CARvac T cells transduced with a lentiviral vector to express

Treatment:

Biological: CD19 CARvac T cells