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New treatment option for CD7 Positive R/R PTCL
Official title To Observe the CD7-targeted CAR-T Therapy in the Treatment of r/r PTCL
ClinicalTrials.gov ID: NCT07143929
What this study is testing
What is CAR-T?
CAR-T is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for cd7 positive r/r ptcl.
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
- To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of refractory or relapsed PTCL.
- Phase 1: an early, usually small safety study
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 80
You may be able to join if
- Age ≥ 18 years old and\<80 years old；
- According to the clinical practice guidelines for T-cell lymphoma of the National Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of...
- Relapse or refractory peripheral T-cell lymphoma, which has not achieved remission or relapsed after receiving ≥ 1 line of systemic treatment in the...
- Histologically confirmed as CD7 positive；
- According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion, and PET/CT should show metabolic...
You likely can't join if
- Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); T-lymphoblastic leukemia/lymphoma（T-ALL/LBL）；
- Primary central nervous system cell lymphoma, or with active central nervous system invasion；
- If anti-tumor treatment has been received before infusion, and drugs have not been completely eliminated must be excluded;
- Individuals with a history of allergies to any component in cellular products.
- Cardiac function:cardiac dysfunction classified as Class III or IV；Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris...
- Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
See the full eligibility criteria
- Age ≥ 18 years old and\<80 years old；
- According to the clinical practice guidelines for T-cell lymphoma of the National Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of peripheral T-cell lymphoma；
- Relapse or refractory peripheral T-cell lymphoma, which has not achieved remission or relapsed after receiving ≥ 1 line of systemic treatment in the past；
- Histologically confirmed as CD7 positive；
- According to Lugano2014 standard, enhanced CT before enrollment should indicate at least one evaluable tumor lesion, and PET/CT should show metabolic activity.
- Blood routine neutrophil count ≥ 1.0×109/L during screening; For individuals without bone marrow invasion, platelet count ≥ 75×109/L, Hb≥80g/L; For individuals with bone marrow invasion, platelet count ≥50×109/L...
- Creatinine clearance rate\>60ml/min (Cockcroft and Gault formula); serum total bilirubin≤1.5 times the upper limit of normal value, and serum ALT and AST ≤ 3 times the upper limit of normal value range;
- left ventricular Ejection fraction (LVEF) ≥ 50%.
- Estimated survival time of over 3 months.
- ECOG: 0-1.
- people or their Legal guardian voluntarily participate in the trial and sign the informed consent form.
- Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary syndrome (SS); T-lymphoblastic leukemia/lymphoma（T-ALL/LBL）；
- Primary central nervous system cell lymphoma, or with active central nervous system invasion；
- If anti-tumor treatment has been received before infusion, and drugs have not been completely eliminated must be excluded;
- Individuals with a history of allergies to any component in cellular products.
- Cardiac function:cardiac dysfunction classified as Class III or IV；Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart disease clinically within 12 months of...
- Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
- Uncontrolled severe active infections.
- The subject has a history of other primary cancers, except for the following.
- people with autoimmune diseases requiring treatment or people requiring Immunosuppressive drug treatment.
- Individuals with graft versus host disease (GvHD) and/or requiring immunosuppressive therapy.
- Live vaccination within 4 weeks prior to screening.
- The subject has a history of alcoholism, drug abuse, or mental illness.
- Individuals with EBV DNA copy numbers greater than the upper limit of normal or positive for EBER; CMV copies greater than the upper limit of normal values; HBV or HCV DNA copy number\>the upper limit of normal value...
- people who were receiving systemic hormone treatment before screening and who were judged by the investigator to need long-term use of systemic hormone during treatment (except for inhalation or local use).
- Individuals who have participated in other clinical trials within the first 4 weeks of screening.
- Pregnant and lactating women and people with Fertility who cannot take effective contraceptive measures (both men and women).
- Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.