The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma
NCT ID: NCT03576807
Last Updated: 2018-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2018-04-04
2020-04-03
Brief Summary
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Detailed Description
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To preliminary explore the safety, tolerability and cellular pharmacokinetics of CD20-CART cell agents in the treatment of relapsed or refractory B-cell lymphomas.
The Secondary purpose:
The following indicators for preliminary observations of CD20-CART cells in the treatment of relapsed or refractory B-cell malignant lymphoma.
1. The determination of lymph nodes to evaluate the anti-tumor effect caused by the input of CD20-CART cells agents.
2. Assessing the ability of CD20-CART cell agents to inhibit the migration of bone marrow and lymph node tumor foci.
3. Assess the killing ability of CD20-CART cell agents to tumor cells in vitro, for patients whose tumor cells could obtain.
4. Disease control rate (DCR) (=CR (complete disease remission) + PR (partial remission of disease) + SD (stable disease), short-term efficacy assessment); Overall survival (OS) and progression-free survival (PFS) (long-term efficacy assessment).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD20 CAR-T cells
Experimental: CD20 CAR-T cells
CD20 CAR-T cells
A total of 1 - 20×10\^6 CD20 CAR-T cells/kg will be administered by IV infusions.
Interventions
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CD20 CAR-T cells
A total of 1 - 20×10\^6 CD20 CAR-T cells/kg will be administered by IV infusions.
Eligibility Criteria
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Inclusion Criteria
2.The patient's age is between 10 and 80 years old. 3. The expected survival of the patient is greater than 12 weeks. 4. Important organ functions must meet the following conditions: The echocardiography indicates that the cardiac ejection fraction is ≥50%. Electrocardiogram showed no obvious abnormalities. Creatinine clearance was calculated using the Cockcroft-Gault formula ≥ 40 ml/min. ALT value and AST value ≤ 3 times normal range. Total bilirubin ≤2.0mg/dl. The coagulation function showed a PT value and APPT value less than 2 times normal. Arterial oxygen saturation (SpO2) is greater than 92%.
5\. Blood routine parameters: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×109/L. 6. The pregnancy test for women of childbearing age must be negative; both male and female patients must agree to use effective contraceptives during the treatment period and within the next year; 7. There are measurable target lesions, see annex to measure lesion definition. 8. Patients have sufficient venous access to apheresis or venous blood and no other leukocyte isolation contraindications.
9.ECOG评分≤2. 10. Patients need to sign informed consent.
Exclusion Criteria
2. Patients have infectious diseases (such as HIV, RPR, active tuberculosis, etc.);
3. The patient is an active hepatitis B or hepatitis C infection.
4. The patient received genetic product treatment within six months.
5. The patient participated in a clinical trial within six months.
6. The patient has a severe autoimmune disease.
7. The doctor thinks that there are other reasons that can't be accepted.
10 Years
80 Years
ALL
No
Sponsors
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Xin Wang
OTHER
Responsible Party
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Xin Wang
The clinical research of targeted CD20-CART cells treatment for refractory or recurrence B lymphocyte lymphoma
Locations
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHLY1701
Identifier Type: -
Identifier Source: org_study_id
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