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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2020

Detailed Description

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: CD19 CARvac T cells
    • CD19 CARvac T cells transduced with a lentiviral vector to express

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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

Secondary Measures

  • Overall Response Rate (ORR)
    • Time Frame: 1 year
    • Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
  • Progression-free survival (PFS)
    • Time Frame: 1 year
  • Overall survival
    • Time Frame: 1 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • iCell Gene Therapeutics
  • Collaborator
    • Peking University Shenzhen Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hongyu Zhang, MD, PhD, Principal Investigator, Peking University Shenzhen Hospital
    • Fang Liu, MD, PhD, Principal Investigator, The General Hospital of Western Theater Command
  • Overall Contact(s)
    • Kevin Pinz, 6315386218, kevin.pinz@icellgene.com

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