Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma

Lymphoma, T-Cell Clinical Trial

Official title:

Clinical Study of Senl-T7 CAR-T Cells in the Treatment of Relapsed or Refractory CD7+ Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928105
• Other study ID #: Senl-T7 CART for CD7+ lymphoma
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2021
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Peihua MD Lu, PhD
• Phone: 008618611636172
• Email: peihua_lu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma.

Description:

Main research purposes: To evaluate the safety and efficacy of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma Secondary research purpose: To investigate the cytokinetic characteristics of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1. Diagnosed as relapsed or refractory lymphoma; 2. Tumor cells express CD7 (express CD7 by flow cytometry or immunohistochemistry); 3. The expected survival period is greater than 12 weeks; 4. KPS or Lansky score =60; 11 5. Age 2-70 years old; 6. HGB=70g/L (can be transfused); 7. Indoor blood oxygen saturation> 90%; 8. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value; 9. The subject or guardian understands and signs the informed consent form;

Exclusion Criteria:

• 1. One of the following cardiac criteria: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT synthesis Syndrome or secondary QT prolongation is at the discretion of the investigator. Echocardiography LVSF<30% or LVEF< 50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (the absence of this symptom confirmed by echocardiography within 12 months after treatment); 2. There is active GVHD; 3. Have a history of severe pulmonary dysfunction diseases; 4. Merge other malignant tumors in advanced stage; 5. Combined with severe infection or persistent infection and cannot be effectively controlled; 6. Combined with severe autoimmune disease or congenital immunodeficiency; 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] test positive); 8. Human immunodeficiency virus (HIV) infection or syphilis infection or HTLV infection; 9. There is a history of severe allergies to biological products (including antibiotics);

10. Clinically significant viral infection, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BKV, HHV(human herpesvirus)-6; 11. There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, Cerebellar diseases, etc.; 12. Female patients are pregnant and lactating, or have a pregnancy plan within 12 months; 13. Circumstances that the researcher believes may increase the risk of the subject or interfere with the results of the test.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell

Intervention

Biological:
• Senl-T7
Patients will be treated with CD7 CAR-T cells

Locations

Country	Name	City	State
China	Hebei yanda Ludaopei Hospital	Yanda	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence and severity of adverse events	To evaluate the possible adverse events occurred within first one month after CD7	First 1 month post CAR-T cells infusion
Primary	Remission Rate	Remission Rate including complete remission(CR)?CR with incomplete blood count recovery(CRi)?No remission(NR)	3 months post CAR-T cells infusion
Primary	duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Primary	progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion
Primary	CAR-T proliferation	the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method	3 months post CAR-T cells infusion
Primary	CAR-T proliferation	percentage of CD7 CAR- T cells measured by flow cytometry method	3 months post CAR-T cells infusion
Primary	Cytokine release	Cytokine( IL-6,IL-10,IFN-?,TNF-a ) concentration (pg/mL) by flow cytometry method	First 1 month post CAR-T cells infusion