Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

March 16, 2018 updated by: Zhao Weili, Ruijin Hospital

The Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma

Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • 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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Shanghai Ruijin 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological detection confirmed CD19/CD22 postive lymphoma;
  • Recieved more than 2 lines of chemotherapy;
  • Not eligible for hematopoietic stem cell transplantation or relapsed after hematopoietic stem cell transplantation;
  • Life expectation for more than 3 months;
  • ECOG ≥ 2;
  • Adequate organ function: EF≥50%; normal ECG; CCR≥40ml/min; ALT and AST ≤ 3 × upper limitation of normal, T-BIL ≤ 2.0mg/dl; PT and APTT < 2 × upper limitation of normal; SpO2 > 92%;
  • CBC results: Hb ≥ 80g/L, ANC > 1 × 10E9/L, Plt ≥ 50 × 10E9/L;
  • Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion;
  • With measurable disease;
  • Written informed consent could be acquired;

Exclusion Criteria:

  • Immunosuppressive agents or steroids in recent 1 week before recruitment;
  • Uncontrolled infection;
  • HIV positive ;
  • Active HBV or HCV infection;
  • Women in pregnancy and lactation;
  • Refuse to conception control during treatment and 1 year after CAR-T infusion;
  • Uncured malignancies other than non-Hodgkin lymphoma;
  • Have participated similar trial for treating relapse/refractory non-Hodgkin lymphoma;
  • Inheritated immune deficiancy;
  • Severe heart disease.

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: CAR-T cell therapy
Patient-derived dual specificity CD19 and CD22 CAR-T
Biological: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
Patient-derived dual specificity CD19 and CD22 CAR-T Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall remission rate
Time Frame: 4 weeks after infusion
Rate of complete remission and patial remission
4 weeks after infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse toxicity
Time Frame: Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused
According to CTCAE 4.0 criteria
Day 0, day 4, week 1, week 3, week 4, month 2, month 12 after CAR-T cells were infused

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Collaborators

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

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)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

March 11, 2018

First Submitted That Met QC Criteria

March 11, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ruijin-CAR-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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