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CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study | Clinical Trials | Clareo Health

RECRUITINGPHASE1

CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study

Open-label, Dose-escalation Phase 1 Clinical Study of SENL101 Autologous T Cell Injection in the Treatment of Adult Patients With Relapsed or Refractory T-LBL/ALL

NCT06136364•Hebei Senlang Biotechnology Inc., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.

Detailed Description

Main research purposes: To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL. Secondary research purposes: To preliminarily evaluate the efficacy, pharmacokinetics and pharmacodynamics of SENL101 in the treatment of patients with relapsed or refractory T-LBL/ALL. Exploratory research purpose： 1. To explore the immunogenicity of SENL101； 2. T cell NK cell recovery time after treatment；

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•According to the WHO hematopoietic and lymphoid tissue tumors classification, Subjects with refractory/relapsing T-LBL/ALL has been adequately treated and there is a lack of effective treatment, met one of the following criteria:
•1. relapse: Primordial cells (\>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears，include：
•1. Early recurrence within 12 months，
•2. Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy，
•3. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ;
•2. Refractory: patients who have received at least two courses standard induction regimen and failed to achieve a complete response or complete remission was not achieved after first-line or above salvage treatment;
•3. 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;
•4. 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.
•5. Life expectancy greater than 12 weeks;
•6. ECOG 0-2;
+9 more criteria

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. History of non-neoplastic central nervous system disease (Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy)
•6. Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);
•7. 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;
•8. 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;
•9. 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);
•10. History of severe allergy to biological products;
+4 more criteria

Locations (1)

Shanghai Ruijin Hospital

Shanghai, China

Key Dates

Start Date

August 15, 2023

Primary Completion Date

August 15, 2024

Completion Date

August 14, 2038

Last Updated

November 18, 2023

Enrollment

ESTIMATED participants

Conditions

T-lymphoblastic LymphomaT-ALL

Interventions

CAR-T

BIOLOGICAL

Contacts

Weili Zhao, Dr

CONTACT

0311-82970973 zwl_trial@163.com

Liang Huang, Dr

CONTACT

0311-82970973 tongjilunli@163.com

Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia

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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: November 18, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study

Inclusion Criteria

Exclusion Criteria

Isatuximab in Adult Patients With Cytologic or Molecular Relapsed/Refractory CD38 Positive T-cell Acute Lymphoblastic Leukemia

To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT

Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

Study of CB-103 in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies

CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation