A Clinical Study of CAR-T Treating Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Ly… (NCT05909527) | Clinical Trial Compass
WithdrawnPhase 1/2
A Clinical Study of CAR-T Treating Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma
Stopped: Due to corporate strategic adjustment.
China0Started 2023-05-01
Plain-language summary
This study is a single arm, non blind, randomized, single center study aimed at evaluating the safety, pharmacokinetic characteristics, and preliminary efficacy of CD7 CAR-T cell injection in r/r T-ALL/LBL subjects.
Who can participate
Age range
2 Years – 60 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
. The patient or his/her guardian understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedure;
. Age 2\~60 (including threshold), regardless of gender;
. According to the WHO 2016 standard, the patients with relapsed/refractory acute T-lymphoblastic leukemia/lymphoma (including early pre T-lymphoblastic leukemia) who failed to receive standard treatment or lacked effective treatment methods met any of the following criteria:
. Glutamic alanine transaminase (ALT) and glutamic oxaloacetic transaminase (AST) ≤ 3 times the upper limit of normal value (ULN). The researcher judges that ALT and AST are abnormal due to diseases (such as liver infiltration or bile duct obstruction), and their indicators can be relaxed to ≤ 5 times ULN;
. Total bilirubin ≤ 1.5 times ULN;
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.
. Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min;
. Hemoglobin ≥ 70g/L or maintained at this level after blood transfusion;
. Indoor oxygen saturation ≥ 92%;
Exclusion criteria
. When collecting and preparing CAR-T blood, those with a tumor load greater than 70%;
. Have malignant tumors other than T-cell hematological malignancies within 5 years, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, breast ductal carcinoma in situ after radical resection cancer.
. CNS leukemia patients with clinical symptoms.
. Hepatitis B surface antigen (HBsAg) is positive, hepatitis B core antibody (HBcAb) is positive and the detection of hepatitis B virus (HBV) DNA titer in peripheral blood is not within the normal reference value range; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Positive individuals for cytomegalovirus (CMV) DNA testing; Syphilis test positive.
. Those with a history of severe allergies or known any of the active ingredients, excipients or mouse-derived products contained in the drug, or those allergic to xenogeneic proteins in this trial, including lymphocyte depletion regimens. Severe allergy history is defined as an allergic reaction of grade two or above, and any of the following clinical manifestations occur when an allergic reaction occurs: airway obstruction (runny nose, cough, wheezing, dyspnea), hypercardia tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), incontinence, laryngeal edema, bronchospasm, cyanosis, shock, respiration, cardiac arrest.
. Severe heart disease, including but not limited to severe arrhythmia, unstable angina, massive myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (refractory Hypertension is defined as: on the basis of improving lifestyle, a reasonable tolerable and sufficient amount of ≥3 kinds of antihypertensive drugs (including diuretics) has been used for \> 1 month and the blood pressure has not reached the standard, or the blood pressure can only be achieved effective control after taking ≥4 kinds of antihypertensive drugs.
. Have unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy.
. Those who have received organ transplants or are about to receive organ transplants (except for hematopoietic stem cell transplants).