CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study (NCT06136364) | Clinical Trial Compass
RecruitingPhase 1
CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study
China9 participantsStarted 2023-08-15
Plain-language summary
To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory T-LBL/ALL.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. relapse: Primordial cells (\>5%)in peripheral blood or bone marrow appeared again after complete remission with standard treatment or Extramedullary disease appears，include：
. Early recurrence within 12 months，
. Late recurrence at 12 months or above and with no remission after a course of standard induction chemotherapy，
. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation ;
. 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;
. 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.
. Life expectancy greater than 12 weeks;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;
. History of non-neoplastic central nervous system disease (Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, neuropathy)
. 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;