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Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T-ALL/T-LBL

RecruitingNAAges 2 Years - 70 YearsAllHebei Senlang Biotechnology Inc., Ltd.
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In plain words

What the trial is, and whether it could suit you

This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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. HGB≥70g/L(blood transfusion allowed); 9. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal; 10. 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); 10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6; 11. 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.; 12. Have received transplant treatment for less than 6 months in prior to enrollment; 13. Being pregnant and lactating or having pregnancy within 12 months; 14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
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What it tests

  • Senl-T7
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Where

1 site
Hebei yanda Hospital
Beijingcun, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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