A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia

December 19, 2017 updated by: Xiulian Sun, Immune Cell, Inc.

A Phase I Trial of CD19 Targeted ICAR19 T Cells in Patients With CD19+ Leukemia and Lymphoma.

Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Weifang, Shandong, China, 261000
        • Recruiting
        • Weifang People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

CD19 positive leukemia and lymphoma，relapsed and/or refractory：

  • survival>12 weeks;
  • FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
  • LVEF≥50%;
  • Creatinine<2.5mg/dl;
  • Bilirubin<2.5mg/dl;
  • ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 x normal;
  • At least 7 days after last chemotherapy;
  • provide with informed consent.

Exclusion Criteria:

  • Active clinically significant CNS dysfunction
  • Pregnant or breast-feeding women.
  • Uncontrolled active infection including hepatitis B or C.
  • HIV positive.
  • Use of systemic steroids within 72 hours.
  • Allogeneic lymphocyte treatments within recent 6 months.
  • Any uncontrolled active medical disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICAR19 CAR-T cells
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 CAR-T cells and the investigators will determine the safety and therapeutic effects of these cells.
Biological: ICAR19 CAR-T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
Other Names:
  • Biological drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the safety of ICAR19 CAR-T cells
Time Frame: 2 years
To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the anti-tumor effect of ICAR19 CAR-T cells
Time Frame: 3 years
Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma
3 years
Survival time of ICAR19 T cells in vivo.
Time Frame: 5 years
To measure the survival time of ICAR19 CAR-T cells in vivo, extra blood will be drawn from patients receive ICAR19 T cells infusion in the follow-up time
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immune Cell, Inc.

Collaborators

Weifang People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 27, 2017

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 19, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD19 Targeted CAR-T

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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