Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Study Details
Study Description
Brief Summary
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
This study is an open, prospective, dose-increasing clinical study with patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma as subjects. In order to evaluate the safety and efficacy of SENL-T7 in patients with CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma, the PK/PD indicators of SENL-T7 are also collected. In this study, no dose grouping is set, and 0.5-2E6 /kg× actual body weight dose is selected for reinfusion according to patients' disease diagnosis and tumor load.
The Main research objectives:
To evaluate the safety and efficacy of SENL-T7 in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
The Secondary research objectives:
To investigate the cellular dynamics of SENL-T7 CAR T cells in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: CD7 CAR-T
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Biological: Senl-T7
Patients will be treated with CD7 CAR-T cells
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Outcome Measures
Primary Outcome Measures
- Safety: Incidence and severity of adverse events [First 1 month post CAR-T cells infusion]
To evaluate the possible adverse events occurred within first one month after CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
- Remission Rate [3 months post CAR-T cells infusion]
To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR/CRi, disease recurrence or progression (PD) will be used for evaluation.
Secondary Outcome Measures
- duration of response (DOR) [24 months post CAR-T cells infusion]
duration of response (DOR)
- CAR-T proliferation [3 months post CAR-T cells infusion]
the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method
- progression-free survival (PFS) [24 months post CAR-T cells infusion]
progression-free survival (PFS) time
- Cytokine release [First 1 month post CAR-T cells infusion]
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry
- CAR-T proliferation [3 months post CAR-T cells infusion]
percentage of CD7 CAR- T cells measured by flow cytometry method
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred;
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CD7 expression in tumor cells was detected by flow cytometry;
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Life expectancy greater than 12 weeks;
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KPS or Lansky score≥60;
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HGB≥70g/L (can be transfused);
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2-70 years old;
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oxygen saturation of blood#90%#;
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Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
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Informed consent explained to, understood by and signed by patient/ guardian.
Exclusion Criteria:
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Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);
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Has an active GvHD;
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Has a history of severe pulmonary function damaging;
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With other tumors which is/are in advanced malignant and has/have systemic metastasis;
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Severe or persistent infection that cannot be effectively controlled;
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Merging severe autoimmune diseases or immunodeficiency disease;
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Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA
+]);
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Patients with HIV infection or syphilis infection;
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Has a history of serious allergies on Biological products (including antibiotics);
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Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6.
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Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;
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Have received transplant treatment for less than 6 months in prior to enrollment;
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Being pregnant and lactating or having pregnancy within 12 months;
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Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hebei yanda Ludaopei Hospital | Beijing | Hebei | China |
Sponsors and Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SenL-T7 for CD7+leukemia/T-LBL