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New treatment option for Bone Marrow Failure Syndrome
Official title CD7 CAR-T Cell Sequential Allo-HSCT for Non-malignant Blood and Immune System Diseases
ClinicalTrials.gov ID: NCT06787560
What this study is testing
What is CD7 CAR-T cells injection?
CD7 CAR-T cells injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bone marrow failure syndrome.
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
- A Clinical Study on the Safety and Effectiveness of CD7 CAR-T Cell Sequential Allogeneic Hematopoietic Stem Cell Transplantation for Non-malignant Blood and Immune System Diseases
- 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
Adults
You may be able to join if
- 1\. Non-malignant blood and immune system diseases include: hereditary bone marrow failure, congenital immune deficiency, hemoglobinopathy and other...
- Confirmed hereditary bone marrow failure syndrome. Including: Fanconi anemia, congenital pure red cell aplastic anemia, congenital dyskeratosis...
- It meets the criteria of clinical manifestation, immune function and gene diagnosis of immune deficiency disease;
- Diagnosed with hemoglobinopathy and dependent on blood transfusions; serum ferritin levels are \< 3000 μg/L, with cardiac and hepatic iron content...
- 2\. Serum total bilirubin ≤1.5 times the upper limit of normal value, serum Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3...
You likely can't join if
- 1\. People with a history of epilepsy or other central nervous system disorders;
- 2\. Epstein-Barr virus (EBV) DNA positive;
- 3\. People with a history of prolonged QT interval or serious heart disease;
- 4\. People with active hepatitis B or C virus;
- 5\. Tuberculosis, AIDS and other major infectious diseases;
- 6\. Sepsis, pulmonary infection, intestinal infection and other major organ infection and poor control, and/or hypersensitive C-reactive protein...
See the full eligibility criteria
- 1\. Non-malignant blood and immune system diseases include: hereditary bone marrow failure, congenital immune deficiency, hemoglobinopathy and other non-malignant blood and immune system diseases,
- Confirmed hereditary bone marrow failure syndrome. Including: Fanconi anemia, congenital pure red cell aplastic anemia, congenital dyskeratosis, Scheux-Day syndrome, congenital neutropenia, various bone marrow failure...
- It meets the criteria of clinical manifestation, immune function and gene diagnosis of immune deficiency disease;
- Diagnosed with hemoglobinopathy and dependent on blood transfusions; serum ferritin levels are \< 3000 μg/L, with cardiac and hepatic iron content indicating moderate or lower iron overload; documentation of iron...
- 2\. Serum total bilirubin ≤1.5 times the upper limit of normal value, serum Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal value range;
- 3\. Echocardiography showed Left ventricular ejection fraction (LVEF) \>50%;
- 4\. Pulse oxygen saturation ≥92% (non-oxygen state);
- 5\. The estimated survival is more than 3 months;
- 6\. ECOG score 0-1;
- 7\. Abdominal B-ultrasonography and other examinations were performed to evaluate spleen size. Splenectomy should be evaluated before transplantation for patients with giant spleen;
- 8\. Women and men who are fertile must consent to the use of appropriate contraception before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn...
- 9\. people who are willing to participate in the study are able to understand and have the ability to sign informed consent.
- 1\. People with a history of epilepsy or other central nervous system disorders;
- 2\. Epstein-Barr virus (EBV) DNA positive;
- 3\. People with a history of prolonged QT interval or serious heart disease;
- 4\. People with active hepatitis B or C virus;
- 5\. Tuberculosis, AIDS and other major infectious diseases;
- 6\. Sepsis, pulmonary infection, intestinal infection and other major organ infection and poor control, and/or hypersensitive C-reactive protein, procalcitonin significantly elevated;
- 7\. People who have previously received other clinical studies and gene therapy;
- 8\. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.