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New treatment option for Aplastic Anemia
Official title CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia
ClinicalTrials.gov ID: NCT06633328
What this study is testing
What is CD7 CAR-T cells injection?
CD7 CAR-T cells injection is an investigational medicine, being studied as a potential treatment for aplastic anemia.
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 single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with severe aplastic anemia
- 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
- Chinese expert consensus on the diagnosis and treatment of aplastic anemia（2017）, Diagnosis of severe aplastic anemia ，1. The degree of bone marrow...
- Suitable donors (relatives) with allogeneic HSCT indications and at least haploid allogeneic transplantation;
- Patients who are not suitable or unwilling to undergo traditional allogeneic hematopoietic stem cell transplantation;
- creatinine clearance \> 60ml/min; without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine...
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
You likely can't join if
- Allergy to pre-treatment measures；
- Those with acute graft versus host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening; Those who have received...
- History of epilepsy or other central nervous system disorders；
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Less than 100 days after allogeneic hematopoietic stem cell transplantation；
- Patients with HIV infection，Active infection of hepatitis B virus or hepatitis C virus，Uncured active infection；
See the full eligibility criteria
- Chinese expert consensus on the diagnosis and treatment of aplastic anemia（2017）, Diagnosis of severe aplastic anemia ，1. The degree of bone marrow cell proliferation \< 25%, or 25%-50% but residual hematopoietic cells...
- Suitable donors (relatives) with allogeneic HSCT indications and at least haploid allogeneic transplantation;
- Patients who are not suitable or unwilling to undergo traditional allogeneic hematopoietic stem cell transplantation;
- creatinine clearance \> 60ml/min; without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times...
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
- No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
- Estimated survival time ≥ 3 months;
- ECOG performance status 0 to 1;
- Females and males of childbearing potential must agree to use adequate contraception prior to study entry, during study participation, and for 6 months after infusion (the safety of this therapy for unborn children is...
- Those who voluntarily participated in this trial and provided informed consent;
- Allergy to pre-treatment measures；
- Those with acute graft versus host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening; Those who have received systemic drug therapy for GvHD within 4 weeks before the reinfusion；
- History of epilepsy or other central nervous system disorders；
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Less than 100 days after allogeneic hematopoietic stem cell transplantation；
- Patients with HIV infection，Active infection of hepatitis B virus or hepatitis C virus，Uncured active infection；
- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- Received anti-cancer chemotherapy or other drug treatment within 2 weeks prior to screening;
- Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hanzhou, 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 Hanzhou, 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.