- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398614
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
Study Overview
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:
- To explore the immunogenicity of SENL101;
- T cell NK cell recovery time after treatment;
- Other indicators of interest to researchers。
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Liang Huang
- Phone Number: 027-83691785
- Email: tongjilunli@163.com
Study Contact Backup
- Name: Jianqiang Li
- Phone Number: 008615511369555
- Email: limmune@gmail.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Tongji hospital
-
Contact:
- Liang Huang
- Phone Number: 027-83691785
- Email: tongjilunli@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The subjects of this study were patients with recurrent or refractory hematocratic malignancies of CD7+.
Inclusion Criteria:
- 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;
- 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;
- 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%;
- Life expectancy greater than 12 weeks;
- ECOG 0-2;
- Age 18-65 (upper and lower limits included);
- HGB at least 70g/L,PLT 20x109/L, can be transfused;
- 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;
- Informed consent explained to, understood by and signed by patient/ guardian.
Exclusion Criteria:
Those who meet any of the following criteria are not eligible to join the group:
- 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);
- If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation;
- Those with active GvHD or those who require immunosuppressive therapy;
- 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;
- Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections);
- 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;
- 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;
- 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);
- History of severe allergy to biological products;
- Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy;
- Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years of cell infusion or male subjects whose partner is planning pregnancy within 2 years of cell infusion;
- Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening;
- Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CD7 CAR-T
SENL101
|
Patients will be treated with CD7 CAR-T cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety: Incidence and severity of adverse events
Time Frame: 24 months post CAR-T cells infusion
|
The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period
|
24 months post CAR-T cells infusion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cytokine release
Time Frame: 12 months post CAR-T cells infusion
|
Changes from baseline in IFN-γ, TNF-α, IL-2, IL-6, IL-10
|
12 months post CAR-T cells infusion
|
CD7 positive cells in peripheral blood at each time point
Time Frame: 12 months post CAR-T cells infusion
|
Absolute value and ratio of CD7 positive cells (T cells NK cells) at each time point in peripheral blood
|
12 months post CAR-T cells infusion
|
T cell subsets
Time Frame: 12 months post CAR-T cells infusion
|
T cell subsets monitoring at each time point (CD4+ CD8+ CD4+/ CD8+ ratio)
|
12 months post CAR-T cells infusion
|
Immunogenicity endpoint
Time Frame: 12 months post CAR-T cells infusion
|
Detectable antibody concentration in serum at each time point
|
12 months post CAR-T cells infusion
|
T cell NK cell recovery time after treatment
Time Frame: 12 months post CAR-T cells infusion
|
Absolute value of T cells NK cells at each time point
|
12 months post CAR-T cells infusion
|
Collaborators and Investigators
Investigators
- Study Director: Liang Huang, Tongji hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SENL101 for CD7+
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma, T-Cell
-
University of Alabama at BirminghamTerminatedAnaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Peripheral T-cell Lymphomas | Adult T-cell Leukemia | Adult T-cell Lymphoma | Peripheral T-cell Lymphoma Unspecified | T/Null Cell Systemic Type | Cutaneous t-Cell Lymphoma With Nodal/Visceral DiseaseUnited States
-
BeiGeneCompletedCutaneous T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Positive | Extranodal NK/T-cell Lymphoma, Nasal Type | Peripheral T Cell Lymphoma | Extranodal NK/T-cell Lymphoma | Peripheral... and other conditionsChina, Taiwan, Germany, France, Canada, Italy
-
National Cancer Institute (NCI)WithdrawnHepatosplenic T-cell Lymphoma | Enteropathy-Associated T-Cell Lymphoma | Adult T-cell Leukemia/Lymphoma | Extranodal NK-/T-cell Lymphoma, Nasal Type | Monomorphic Epiteliotrophic Intestinal T-cell LymphomaUnited States
-
Deepa JagadeeshRecruitingAngioimmunoblastic T-cell Lymphoma | T-cell Lymphoma | Adult T-cell Leukemia/Lymphoma | Enteropathy Associated T-cell Lymphoma | Hepato-splenic T-cell Lymphoma | NK T-cell LymphomaUnited States
-
University of NebraskaNational Cancer Institute (NCI); AmgenCompletedPeripheral T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Recurrent Adult T-cell Leukemia/LymphomaUnited States
-
National Cancer Institute (NCI)CompletedPeripheral T-Cell Lymphoma (PTCL) | T-Cell Prolymphocytic Leukemia | Cutaneous T Cell Lymphoma (CTCL) | T-Cell Lymphoma Relapsed | Adult T-Cell Leukemia (ATL)United States
-
Samsung Medical CenterNational Cancer Center, Korea; Asan Medical Center; Yonsei University; Korea Cancer...CompletedCutaneous T Cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-negative | Angioimmunoblastic T Cell Lymphoma | Peripheral T Cell Lymphoma UnspecifiedKorea, Republic of
-
SciTech Development, LLCRush University Medical CenterRecruitingMycosis Fungoides | Cutaneous T-cell Lymphoma | Peripheral T-cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | T-cell Lymphoma | Cutaneous/Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Classified | Primary Cutaneous T-cell Lymphoma | Cutaneous T-Cell Lymphoma, Unspecified | Follicular... and other conditionsUnited States
-
Shanghai General Hospital, Shanghai Jiao Tong University...SuspendedAngioimmunoblastic T-cell Lymphoma | Peripheral T Cell Lymphoma | Anaplastic Lymphoma | Acute T Cell Leukemia | T-lymphoblastic LymphomaChina
-
Legend Biotech USA IncActive, not recruitingT-Cell Lymphoma | Peripheral T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Recurrent | Peripheral T-Cell Lymphoma RecurrentUnited States