Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
NCT ID: NCT05528887
Last Updated: 2022-09-06
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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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2021-09-16
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous CAR-T cells
A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells.
Autologous CAR-T cells
D0: CAR-T cells will be infused intravenously.
Fludarabine
D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.
Cyclophosphamide
D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.
Interventions
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Autologous CAR-T cells
D0: CAR-T cells will be infused intravenously.
Fludarabine
D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.
Cyclophosphamide
D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Positive expression of specific antigens.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
4. Adequate organ functions:
* Serum bilirubin ≤ 35 μmol/L;
* Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2;
* Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN);
* Brain natriuretic peptide (BNP)\<80 pg/mL.
5. Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.
Exclusion Criteria
2. History of cardiac diseases:
* Left ventricular ejection fraction (LVEF) \< 50%;
* Class III or IV heart failure as defined by the New York Heart Association (NYHA).
3. History of another malignancy tumor.
4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
6. Uncontrolled fungal, bacterial, viral, or other infection.
7. Female subjects who are pregnant or lactating.
18 Years
75 Years
ALL
No
Sponsors
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UTC Therapeutics Inc.
INDUSTRY
The Affiliated People's Hospital of Ningbo University
OTHER_GOV
Responsible Party
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Principal Investigators
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Ying Lu
Role: PRINCIPAL_INVESTIGATOR
The Affiliated People's Hospital of Ningbo University
Locations
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The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-037
Identifier Type: -
Identifier Source: org_study_id
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