Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia
NCT ID: NCT04762485
Last Updated: 2021-06-02
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/PHASE2
20 participants
INTERVENTIONAL
2021-06-01
2024-02-28
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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CD38 positive relapsed or refractory acute leukemia
Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (0.5- 10)x10\^6 CD7 CAR-T cells/kg
Humanized CD7 CAR-T cells
Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (0.5-10)x10\^6 CD7 CAR-T cells/kg
Interventions
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Humanized CD7 CAR-T cells
Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (0.5-10)x10\^6 CD7 CAR-T cells/kg
Eligibility Criteria
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Inclusion Criteria
2. Age 12-65 years.
3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
4. CD7 on leukemia is \>30% positive detected with flow cytometry.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
Exclusion Criteria
2. Patients with congenital immunodeficiency.
3. Patients with central nervous system leukemia.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.
12 Years
65 Years
ALL
No
Sponsors
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PersonGen BioTherapeutics (Suzhou) Co., Ltd.
INDUSTRY
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
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Principal Investigators
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xiaowen tang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, (Select), China
Countries
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Central Contacts
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Facility Contacts
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References
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Cao X, Dai H, Cui Q, Li Z, Shen W, Pan J, Shen H, Ma Q, Li M, Chen S, Chen J, Zhu X, Meng H, Yang L, Wu D, Tang X. CD7-directed CAR T-cell therapy: a potential immunotherapy strategy for relapsed/refractory acute myeloid leukemia. Exp Hematol Oncol. 2022 Sep 29;11(1):67. doi: 10.1186/s40164-022-00318-6.
Other Identifiers
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PGSDFYY 202101
Identifier Type: -
Identifier Source: org_study_id
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