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 range2 Years – 60 Years
SexALL
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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;
✓. 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).