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

NCT04928105 | Unknown

• 1 other identifier: Senl-T7 CART for CD7+ lymphoma
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, T-Cell

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• duration of response (DOR)

  duration of response (DOR)

  24 months post CAR-T cells infusion

• progression-free survival (PFS)

  progression-free survival (PFS) time

  24 months post CAR-T cells infusion

• 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

• CAR-T proliferation

  percentage of CD7 CAR- T cells measured by flow cytometry method

  3 months post CAR-T cells infusion

• Cytokine release

  Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

  First 1 month post CAR-T cells infusion

Study Arms (1)

CD7 CAR-T

EXPERIMENTAL

Biological: Senl-T7

Interventions

Senl-T7 BIOLOGICAL

Patients will be treated with CD7 CAR-T cells

CD7 CAR-T

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

Hebei yanda Ludaopei Hospital

Yanda, Hebei, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Peihua MD Lu, PhD

  Hebei Yanda Ludaopei Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peihua MD Lu, PhD

CONTACT

008618611636172; peihua_lu@126.com

Jianqiang MD Li, PhD

CONTACT

008615511369555; limmune@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: January 27, 2021
• Primary Completion: January 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 31, 2022

Record last verified: 2021-06

Locations

CN (1)