Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia
Study Details
Study Description
Brief Summary
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Biological: 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
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events [12 months]
Adverse events are evaluated with CTCAE V5.0
Secondary Outcome Measures
- Overall response rate (ORR) [2 years]
ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts <5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0x 10^9/L; platelet count >100x10^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (<1.0x10^9/L) or thrombocytopenia (<100x10^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
- Cumulative incidence of relapse(CIR) [2 years]
time from the date of achievement of a remission until the date of relapse.
- the duration of CAR T-cells in vivo [2 years]
the time of CAR-T cells' persistence in blood and the copies of CAR-T cells
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed CD7 positive relapsed/refractory acute leukemia.
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Age 12-65 years.
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Eastern Cooperative Oncology Group (ECOG) score 0-2.
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CD7 on leukemia is >30% positive detected with flow cytometry.
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Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
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Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.
Exclusion Criteria:
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Patients are pregnant or lactating
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Patients with congenital immunodeficiency.
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Patients with central nervous system leukemia.
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Patients with uncontrolled active infection.
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Patients with active hepatitis B or hepatitis C infection.
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Patients with HIV infection.
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Patients with atrial or venous thrombosis or embolism.
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Patients with myo-infarction or severe arrythmia in the recent 6 months.
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Other comorbidities that investigators considered not suitable for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Soochow University | Suzhou | (Select) | China | 215000 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Investigators
- Principal Investigator: xiaowen tang, Ph.D, The First Affiliated Hospital of Soochow University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PGSDFYY 202101