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Status unknownNCT05263817Updated Mar 3, 2022

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

An Early Phase 1 interventional study of CD19/BCMA CAR T-cells in POEMS Syndrome, Amyloidosis and Autoimmune Hemolytic Anemia, sponsored by Zhejiang University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by Zhejiang University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • POEMS Syndrome
  • Amyloidosis
  • Autoimmune Hemolytic Anemia
  • Vasculitis

Keywords

  • CD19 CAR-T
  • BCMA CAR-T
  • POEMS Syndrome
  • Amyloidosis
  • Autoimmune Hemolytic Anemia
  • Vasculitis
03

In context

Vasculitis

230 studies on the registry are indexed under Vasculitis; 68 are open to participants now.

This study's planned enrollment of 75 is above the median of 48 across 119 interventional studies indexed under Vasculitis.

Browse Vasculitis studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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.

      1. After glucocorticoids, cyclophosphamide or methotrexate treatments there are still relapsed and refractory diseases, or clearly show intolerance/toxicity to these drugs.
      1. 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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    POEMS Syndrome

    Biological: CD19/BCMA CAR T-cells

  • Experimental
    Amyloidosis

    Biological: CD19/BCMA CAR T-cells

  • Experimental
    Autoimmune Hemolytic Anemia

    Biological: CD19/BCMA CAR T-cells

  • Experimental
    Vasculitis

    Biological: CD19/BCMA CAR T-cells

Interventions

  • BiologicalCD19/BCMA CAR T-cells

    Each subject receive CD19/BCMA CAR T-cells by intravenous infusion

    Also known as: CD19/BCMA CAR T-cells injection

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Adverse events assessed according to NCI-CTCAE v5.0 criteria

    Time frame: Baseline up to 28 days after CD19/BCMA targeted CAR T-cells infusion

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

    Time frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion

Secondary outcomes

  1. Titer of auto-antibody Titer of auto-antibody titer of auto-antibody

    In peripheral blood and bone marrow

    Time frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion

  2. Overall response rate (ORR)

    Proportion of subjects with complete or partial remission

    Time frame: Up to 2 years after CD19/BCMA targeted CAR T-cells infusion

  3. Best overall response, BOR

    Assessment of ORR at ≤3 month

    Time frame: At ≤3 month

  4. Overall survival (OS)

    The time from the cell reinfusion to death due to any cause

    Time frame: From CD19/BCMA CAR-T infusion to death，up to 2 years

  5. Duration of remission, DOR

    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

    Time frame: 2 years post CD19/BCMA CAR-T cells infusion

07

Study locations

1 of 1 sites recruiting
  • The first affiliated hospital of medical college of zhejiang university
    Hangzhou, Zhejiang 310003, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05263817
Lead sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
Responsible party
He Huang (The President of The First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang University) — Principal investigator
First posted
Mar 3, 2022
Start date
Oct 8, 2021
Primary completion
Oct 1, 2024 (estimated)
Completion
Oct 1, 2024 (estimated)
Last update
Mar 3, 2022

Study contacts

He Huang, PhD
Contact
hehuangyu@126.com
+8613605714822
Yongxian Hu, PhD
Contact
huyongxian2000@aliyun.com
+8615957162012
He Huang, PhD
principal investigator · First Affiliated Hospital of Zhejiang University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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