Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy for Relapsed Refractory B-cell Malignancies
NCT ID: NCT04007978
Last Updated: 2019-08-07
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
50 participants
INTERVENTIONAL
2019-08-05
2022-12-30
Brief Summary
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Detailed Description
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This study aims to evaluate the safety and effectiveness of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell Malignancies.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Third generation CAR-T cells
Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
Third generation CAR-T cells
Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
Interventions
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Third generation CAR-T cells
Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
Eligibility Criteria
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Inclusion Criteria
2. Male or female patients aged 14 to 70 years (including 14 and 70 years old).
3. Pathological and histological examination confirmed CD22+ B-cell malignancies, and patients met the following criteria for refractory or relapsed B-cell malignancies.
A.Refractory/relapsed B-cell lymphoblastic leukemia (Meeting one of the following)
i. Recurrence within 6 months after first remission.
ii. Primary refractory disease which cannnot achieve complete remission (CR) after 2 cycles of standardized chemotherapy regimen.
iii. Failure to achieve CR or relapse after one line or multiple lines of salvage chemotherapy.
iv. Not suitable for hematopoietic stem cell transplantation (HSCT), or abandon HSCT due to various restrictions, or relapse after HSCT.
B.Refractory/relapsed B-cell lymphoma (Meeting 1 of the first 4 items plus item 5)
i. Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
ii. Achieved CR after standard chemotherapy, but relapsed within 6 months.
iii. 2 or more relapses after CR.
iv. Not suitable for HSCT, or abandon HSCT due to various restrictions, or relapse after HSCT.
v. Subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines.
4. B-cell malignancies include the following three types
A. B-cell acute lymphoblastic leukemia (B-ALL)
B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL)
C. Invasive B-cell lymphoma (DLBCL, BL, MCL)
5. Having a measurable or evaluable lesion
A. Patients with lymphoma require a single lesion≥15mm or 2 or more lesions≥10mm.
B. Patients with leukemia require persistent positive or positive relapse of bone marrow MRD.
6. Patient's main organs functioning well
A. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L
B. Renal function: Creatinine \< 220μmol/L.
C. Pulmonary function: Indoor oxygen saturation≥95%.
D. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥40%.
7. The patients did not receive any antitumor treatments such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 4 weeks before enrollment, and the toxicity related to previous treatments had returned to \< 1 level at enrollment (except for low grade toxicity such as alopecia).
8. The patient's peripheral superficial venous blood flow smoothly, which can meet the needs of intravenous drip.
9. Patient ECOG score≤ 2, estimated survival time≥3 months.
Exclusion Criteria
2. Women who are pregnant (urine/blood pregnancy test positive) or lactating.
3. Male or female with a pregnancy plan in the next 1 year.
4. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment.
5. Uncontrolled infectious disease within 4 weeks prior to enrollment.
6. Active hepatitis B/C virus infection.
7. HIV infected patients.
8. Suffering from a serious autoimmune disease or immunodeficiency disease.
9. The patient is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
10. The patient participated in other clinical trials within 6 weeks prior to enrollment.
11. Systemic use of corticosteroids within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
12. Suffering from mental diseases.
13. Patient has drug abuse/addiction.
14. According to the researcher's judgment, the patient has other unsuitable enrollment conditions.
14 Years
70 Years
ALL
No
Sponsors
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Wuhan Bio-Raid Biotechnology Co., Ltd.
UNKNOWN
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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MEI HENG
Principal Investigator
Principal Investigators
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Heng Mei, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WHUH-CART-CD22-01
Identifier Type: -
Identifier Source: org_study_id
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