- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05263817
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: He Huang, PhD
- Phone Number: +8613605714822
- Email: hehuangyu@126.com
Study Contact Backup
- Name: Yongxian Hu, PhD
- Phone Number: +8615957162012
- Email: huyongxian2000@aliyun.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The first affiliated hospital of medical college of zhejiang university
-
Contact:
- Yongxian Hu, PhD
- Phone Number: +8615957162012
- Email: huyongxian2000@aliyun.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
- Those who have used any gene therapy products before.
- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- Those who suffer from other uncontrolled diseases are not suitable to join the study;
- HIV infection;
- Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Study Plan
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
|
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Other Names:
|
Experimental: Amyloidosis
|
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Other Names:
|
Experimental: Autoimmune Hemolytic Anemia
|
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Other Names:
|
Experimental: Vasculitis
|
Each subject receive CD19/BCMA CAR T-cells by intravenous infusion
Other Names:
|
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Nervous System Diseases
- Immune System Diseases
- Immunoproliferative Disorders
- Autoimmune Diseases
- Disease
- Congenital Abnormalities
- Hematologic Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Paraproteinemias
- Blood Protein Disorders
- Proteostasis Deficiencies
- Abnormalities, Multiple
- Polyneuropathies
- Syndrome
- Amyloidosis
- Anemia
- Vasculitis
- Hemolysis
- Anemia, Hemolytic
- Anemia, Hemolytic, Autoimmune
- POEMS Syndrome
Other Study ID Numbers
- CD19/BCMA-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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