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UNKNOWNEARLY_PHASE1

A Clinical Study of CD19/BCMA CAR-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

NCT05263817•Zhejiang University

View on ClinicalTrials.gov

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

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

•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;
+2 more criteria

Locations (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Key Dates

Start Date

October 8, 2021

Primary Completion Date

October 1, 2024

Completion Date

October 1, 2024

Last Updated

March 3, 2022

Enrollment

ESTIMATED participants

Conditions

POEMS SyndromeAmyloidosisAutoimmune Hemolytic AnemiaVasculitis

Interventions

CD19/BCMA CAR T-cells

BIOLOGICAL

Contacts

He Huang, PhD

CONTACT

+8613605714822 hehuangyu@126.com

Yongxian Hu, PhD

CONTACT

+8615957162012 huyongxian2000@aliyun.com

Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

NCT06192979

Amyloidosis; SystemicAL Amyloidosis

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RECRUITINGPHASE3

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

NCT07052903

Transthyretin Amyloidosis With Cardiomyopathy

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis

National Longitudinal Cohort of Hematological Diseases

A Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Newly Diagnosed Systemic Light-Chain Amyloidosis (NDSLCA)

Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimmune Diseases