A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis

February 21, 2022 updated by: He Huang, Zhejiang University

A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis

A Clinical Study on the Safety and Effectiveness of CD19/BCMA Chimeric Antigen Receptor T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

POEMS syndrome, amyloidosis, autoimmune hemolytic anemia, vasculitis and other diseases may only show local pathological damage or systemic lesions. If they are not diagnosed and treated in time or poorly controlled, they will progress as the course of the disease progresses. Risk of disability or even death.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Early 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 Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The first affiliated hospital of medical college of zhejiang university
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Diagnosed with POEMS syndrome, amyloidosis, autoimmune hemolytic anemia, vasculitis, and the curative effect of conventional hormones, radiotherapy and chemotherapy, protease inhibitors is not good and (or) no effective treatment means.

    2. After glucocorticoids, cyclophosphamide or methotrexate treatments there are still relapsed and refractory diseases, or clearly show intolerance/toxicity to these drugs.

    3. Estimated survival time> 12 weeks; 4. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up; 5. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

  • Subjects with any of the following exclusion criteria were not eligible for this trial:

    1. History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
    2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past;
    3. Pregnant (or lactating) women;
    4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
    5. Active infection of hepatitis B virus or hepatitis C virus;
    6. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
    7. Those who have used any gene therapy products before.
    8. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
    9. Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
    10. Those who suffer from other uncontrolled diseases are not suitable to join the study;
    11. HIV infection;
    12. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POEMS Syndrome
Biological: CD19/BCMA CAR T-cells
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Other Names:
  • CD19/BCMA CAR T-cells injection
Experimental: Amyloidosis
Biological: CD19/BCMA CAR T-cells
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Other Names:
  • CD19/BCMA CAR T-cells injection
Experimental: Autoimmune Hemolytic Anemia
Biological: CD19/BCMA CAR T-cells
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Other Names:
  • CD19/BCMA CAR T-cells injection
Experimental: Vasculitis
Biological: CD19/BCMA CAR T-cells
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Other Names:
  • CD19/BCMA CAR T-cells injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: Baseline up to 28 days after CD19/BCMA targeted CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Baseline up to 28 days after CD19/BCMA targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Up to 2 years after CD19/BCMA targeted CAR T-cells infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Titer of auto-antibody Titer of auto-antibody titer of auto-antibody
Time Frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
In peripheral blood and bone marrow
Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Overall response rate (ORR)
Time Frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Proportion of subjects with complete or partial remission
Up to 2 years after CD19/BCMA targeted CAR T-cells infusion
Best overall response, BOR
Time Frame: At ≤3 month
Assessment of ORR at ≤3 month
At ≤3 month
Overall survival (OS)
Time Frame: From CD19/BCMA CAR-T infusion to death，up to 2 years
The time from the cell reinfusion to death due to any cause
From CD19/BCMA CAR-T infusion to death，up to 2 years
Duration of remission, DOR
Time Frame: 2 years post CD19/BCMA CAR-T cells infusion
The time from the first assessment of remission or partial remission of the disease to the first assessment of disease progression or death from any cause
2 years post CD19/BCMA CAR-T cells infusion

Collaborators and Investigators

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

Sponsor

Zhejiang University

Collaborators

Yake Biotechnology 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)

October 8, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD19/BCMA-005

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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