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SENL101 Autologous T Cell Injection in Adults With Relapsed or Refractory CD7+ Hematolymphoid Malignancies | Clinical Trials | Clareo Health

UNKNOWNPHASE1

SENL101 Autologous T Cell Injection in Adults With Relapsed or Refractory CD7+ Hematolymphoid Malignancies

Early Clinical Study of SENL101 Autologous T Cell Injection in the Treatment of Adult Patients With Relapsed or Refractory CD7+ Hematolymphoid Malignancies

NCT05398614•Hebei Senlang Biotechnology Inc., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies.

Detailed Description

Main research purposes: To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies. Secondary research purposes: To preliminarily evaluate the efficacy, pharmacokinetics and pharmacodynamics of SENL101 in the treatment of patients with relapsed or refractory CD7+ hemolymphoid malignancies. Exploratory research purpose： 1. To explore the immunogenicity of SENL101； 2. T cell NK cell recovery time after treatment； 3. Other indicators of interest to researchers。

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subjects of this study were patients with recurrent or refractory hematocratic malignancies of CD7+.
•1. Subjects diagnosed with refractory/relapsing T-cell leukaemia/lymphoma met one of the following criteria: relapse: disease recurrence after complete remission with at least two prior regiments or complete remission with stem cell transplantation; Refractory: patients who have received at least two previous treatment regimens and failed to achieve a complete or partial response after the last treatment (leukemia patients), or failed to achieve a response after stem cell transplantation or develop disease progression;
•2. The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening;
•3. If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry. If the surface phenotype of peripheral blood tumor cells was not CD4 and CD8 double negative, the proportion of tumor cells in peripheral blood was ≤1%;
•4. Life expectancy greater than 12 weeks;
•5. ECOG 0-2;
•6. Age 18-65 (upper and lower limits included);
•7. HGB at least 70g/L,PLT 20x109/L, can be transfused;
•8. Liver and kidney functions The cardiopulmonary functions meet the following requirements: Oxygen saturation under air ≥ 92%; LVEF≥45%; Total bilirubin \<3×ULN; ALT/AST\<5×ULN; Creatinine \<1.5×ULN;
•9. Informed consent explained to, understood by and signed by patient/ guardian.

Exclusion Criteria

•1. New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval \>480ms at screening (QTc interval calculated by Fridericia formula);
•2. If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;
•3. Those with active GvHD or those who require immunosuppressive therapy;
•4. Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ;
•5. Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);
•6. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease modulating medication within the past 2 years;
•7. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded;
•8. Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug (whichever is longer);
•9. History of severe allergy to biological products;
•10. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy;
+3 more criteria

Locations (1)

Tongji Hospital

Wuhan, Hubei, China

Key Dates

Start Date

May 1, 2022

Primary Completion Date

December 30, 2023

Completion Date

June 30, 2024

Last Updated

June 1, 2022

Enrollment

ESTIMATED participants

Conditions

T-ALLLymphoma, T-Cell

Interventions

SENL101

BIOLOGICAL

Contacts

Liang Huang

CONTACT

027-83691785 tongjilunli@163.com

Jianqiang Li

CONTACT

008615511369555 limmune@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SENL101 Autologous T Cell Injection in Adults With Relapsed or Refractory CD7+ Hematolymphoid Malignancies

Inclusion Criteria

Exclusion Criteria

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