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

NCT ID: NCT04916860

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2023-03-31

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

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CD7 CAR-T

Group Type: EXPERIMENTAL

Senl-T7

Intervention Type: BIOLOGICAL

Patients will be treated with CD7 CAR-T cells

Interventions

Senl-T7

Patients will be treated with CD7 CAR-T cells

Intervention Type: BIOLOGICAL

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. 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);

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hebei yanda Ludaopei Hospital

Beijingcun, Hebei, China

Countries

China

Other Identifiers

SenL-T7 for CD7+leukemia/T-LBL

Identifier Type: -

Identifier Source: org_study_id