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

Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T Lymphoblastic Leukemia and T Lymphoblastic Lymphoma

Sponsors

Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Source Hebei Senlang Biotechnology Inc., Ltd.
Brief Summary

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.

Detailed Description

The CARs consist of an anti-CD7 single-chain variable fragment(scFv), a portion of the human CD137(4-1BB) molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

Overall Status Recruiting
Start Date 2022-08-29
Completion Date 2027-12-30
Primary Completion Date 2027-10-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety: Incidence and severity of adverse events First 1 month post CAR-T cells infusion
Remission Rate 3 months post CAR-T cells infusion
Enrollment 100
Condition
Intervention

Intervention Type: Biological

Intervention Name: Senl-T7

Description: Patients will be treated with CD7 CAR-T cells

Arm Group Label: CD-7 CART

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

2 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Xian Zhang

Phone: 008618611636172

Email: [email protected]

Location
Facility: Status: Contact: Hebei yanda Hospital xian zhang [email protected]
Location Countries

China

Verification Date

2022-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: CD-7 CART

Type: Experimental

Description: Patients will be treated with CD7 CAR-T cells

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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