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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 | Clinical Trials | Clareo Health

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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

NCT04916860•Hebei Senlang Biotechnology Inc., Ltd.

View on ClinicalTrials.gov

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

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.

Eligibility

Age

2 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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；
•2. CD7 expression in tumor cells was detected by flow cytometry；
•3. Life expectancy greater than 12 weeks；
•4. KPS or Lansky score≥60;
•5. HGB≥70g/L (can be transfused);
•6. 2-70 years old;
•7. oxygen saturation of blood#90%#;
•8. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;
•9. Informed consent explained to, understood by and signed by patient/ guardian.

Exclusion Criteria

•1. 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);
•2. Has an active GvHD;
•3. Has a history of severe pulmonary function damaging;
•4. With other tumors which is/are in advanced malignant and has/have systemic metastasis;
•5. Severe or persistent infection that cannot be effectively controlled;
•6. Merging severe autoimmune diseases or immunodeficiency disease;
•7. Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA
•+\]);
•8. Patients with HIV infection or syphilis infection;
•9. Has a history of serious allergies on Biological products (including antibiotics);
+5 more criteria

Locations (1)

Hebei yanda Ludaopei Hospital

Beijingcun, Hebei, China

Key Dates

Start Date

January 27, 2021

Primary Completion Date

January 31, 2023

Completion Date

March 31, 2023

Last Updated

March 31, 2023

Enrollment

100

ESTIMATED participants

Conditions

SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Interventions

Senl-T7

BIOLOGICAL