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

Sponsor
iCell Gene Therapeutics (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04156243
Collaborator
Peking University Shenzhen Hospital (Other), Chengdu Military General Hospital (Other), iCAR Bio Therapeutics Ltd. (Industry)
20
Enrollment
2
Locations
1
Arm
24.9
Anticipated Duration (Months)
10
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: CD19 CARvac T cells
 Early Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 1, 2018
Anticipated Primary Completion Date :
Feb 28, 2020
Anticipated Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: CD19 CARvac T cells

CD19 CARvac T cells transduced with a lentiviral vector to express

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.

Outcome Measures

Primary Outcome Measures

  1. 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 [28 days]

  2. Type of dose-limiting toxicity (DLT) [28 days]

  3. 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 [2 years]

Secondary Outcome Measures

  1. Overall Response Rate (ORR) [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

  2. Progression-free survival (PFS) [1 year]

  3. Overall survival [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The General Hospital of Western Theater Command Chengdu China
2 Peking University Shenzhen Hospital Shenzhen China

Sponsors and Collaborators

  • iCell Gene Therapeutics
  • Peking University Shenzhen Hospital
  • Chengdu Military General Hospital
  • iCAR Bio Therapeutics Ltd.

Investigators

  • Principal Investigator: Hongyu Zhang, MD, PhD, Peking University Shenzhen Hospital
  • Principal Investigator: Fang Liu, MD, PhD, The General Hospital of Western Theater Command

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
iCell Gene Therapeutics
ClinicalTrials.gov Identifier:
NCT04156243
Other Study ID Numbers:
  • ICG134-001
First Posted:
Nov 7, 2019
Last Update Posted:
Nov 12, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by iCell Gene Therapeutics
CD19
CD19 CAR T cell
Additional relevant MeSH terms:
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Nov 12, 2019