Trial | NCT04156243  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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.
CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat
Study Started
Feb 01
2018
Primary Completion
Feb 28
2020
Anticipated
Study Completion
Feb 28
2020
Anticipated
Last Update
Nov 12
2019

Biological CD19 CARvac T cells

CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

CD19 CARvac T cells Experimental

CD19 CARvac T cells transduced with a lentiviral vector to express

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
No Results Posted