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New treatment option for T-Cell Non-Hodgkin Lymphoma
Official title CD5 CAR T-Cell Therapy for r/r T-cell Lymphomas
ClinicalTrials.gov ID: NCT07022964
What this study is testing
What is CD5 CAR-T cells infusion?
CD5 CAR-T cells infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for t-cell non-hodgkin 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
- This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD5 CAR T-cell therapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 70
You may be able to join if
- (Patients who met all the were eligible for enrolment):
- Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available...
- Male or female, age 14-70;
- Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2;
- life expectancy is at least 60 days;
You likely can't join if
- (Patients who fulfil any of the following criteria may not be enrolled):
- Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood...
- Intracranial hypertension or cerebral impaired consciousness;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- With other types of malignancy;
See the full eligibility criteria
- (Patients who met all the were eligible for enrolment):
- Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., HSCT or...
- Male or female, age 14-70;
- Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2;
- life expectancy is at least 60 days;
- people should be capable of understanding and signing the informed consent form prior to any screening procedures. people are willing to follow the study visit schedule and associated study procedures as specified in...
- (Patients who fulfil any of the following criteria may not be enrolled):
- Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load \>30%; patients without history of allogeneic HSCT and...
- Intracranial hypertension or cerebral impaired consciousness;
- Symptomatic heart failure or severe arrhythmia;
- Symptoms of severe respiratory failure;
- With other types of malignancy;
- Diffuse intravascular coagulation;
- Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
- With sepsis or other uncontrollable infection;
- Suffering from uncontrollable diabetes mellitus;
- Severe mental disorders;
- Have significant intracranial lesions on cranial MRI;
- Organ transplantation (excluding haematopoietic stem cell transplantation) history;
- Female patients (patients of childbearing potential) with positive blood HCG test;
- Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Shanghai, 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, 14 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Shanghai, 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.