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New treatment option for T Lymphoblastic Leukemia/Lymphoma
Official title CD7 CAR-T Cells in T-cell Lymphoma/Leukemia
ClinicalTrials.gov ID: NCT05620680
What this study is testing
What is CD7 CAR-T cells?
CD7 CAR-T cells is an investigational medicine, being studied as a potential treatment for t lymphoblastic leukemia/lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- T-cell lymphoma/leukemia is a group of highly lethal diseases with a high relapse rate and poor prognosis. CD7 was proved to be widely expressed in T-cell malignant, which makes it a promising therapeutic target.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
- The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian;
- According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (2020. V1) practice...
- Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any of the following: 1) Failure to obtain CR at the end of induction...
You likely can't join if
- Those who have a history of allergy to any of the ingredients in cell products;
- Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper...
- Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading...
- Abnormal lung function, blood oxygen saturation under indoor air \< 92%;
- Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment;
- Grade 3 hypertension with poor control of blood pressure with medication;
See the full eligibility criteria
- Age 18-75 (≥ 18 years old, ≤ 75 years old), gender is not limited;
- The subject voluntarily participates in the research and signs the "Informed Consent" by himself or his legal guardian;
- According to the National Comprehensive Cancer Network (NCCN) T lymphocytic lymphoma (2020.V1)/acute lymphoblastic leukemia (2020. V1) practice guidelines, diagnosed with T-cell lymphoma;
- Meet the diagnostic criteria for relapsed/refractory T-cell lymphoma, including any of the following: 1) Failure to obtain CR at the end of induction therapy; 2) Patients who have obtained CR have blasts in peripheral...
- Those who have a history of allergy to any of the ingredients in cell products;
- Laboratory tests for the following: including but not limited to, total serum bilirubin≧ 1.5mg/dl; Serum ALT or AST greater than 2.5 times the upper limit of normal; Blood creatinine≧ 2.0mg/dl; Platelet count≦ 10×109/L;
- Patients with cardiac insufficiency who belong to class III or IV according to the New York Cardiology Association (NYHA) cardiac function grading standards; or echocardiography with left ventricular ejection fraction...
- Abnormal lung function, blood oxygen saturation under indoor air \< 92%;
- Myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other serious clinical heart disease within 12 months before enrollment;
- Grade 3 hypertension with poor control of blood pressure with medication;
- Patients with other advanced tumors (those who are assessed as stable after treatment of other tumors can be enrolled);
- Previous head trauma, impaired consciousness, epilepsy, more serious cerebral ischemia or cerebral hemorrhage disease;
- Known central nervous system leukemia (CNS2 or CNS3), resistance to intrathecal chemotherapy injections and/or ongoing head and/or spinal radiation therapy; Previous CNS history but has been effectively controlled to...
- Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressant therapy;
- presence of uncontrolled, active infection;
- Have previously used any CAR-T cell product or other genetically modified T cell therapy;
- Live vaccination within 4 weeks prior to enrollment;
- HIV, HBV, HCV and TPPA/RPR infections, and HBV carriers;
- Subject has a history of alcoholism, drug addiction or mental illness;
- The subject has participated in any other clinical research within 3 months before joining this clinical study;
- Female people have any of the following conditions: a) are pregnant/lactating; or b) have plans to become pregnant during the trial; or c) are of childbearing potential and unable to use effective contraception;
- There are other circumstances in which the investigator believes that the subject is not suitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.