BridgeMD
New treatment option for T-cell Acute Lymphoblastic Leukemia
Official title Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies
ClinicalTrials.gov ID: NCT04033302
What this study is testing
What is CD7-specific CAR gene-engineered T cells?
CD7-specific CAR gene-engineered T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for t-cell acute lymphoblastic leukemia.
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
- The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cell therapy against CD7-positive hematological malignancies using CD7 specific CAR T cells. The study also aims to learn more about the function of CD7 CAR T cells and their persistence in patients of hematological malignancies.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 75
You may be able to join if
- Age older than 6 months.
- Confirmed expression of CD7 or additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.
- Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen...
- Hgb≥80g/L.
You likely can't join if
- Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled...
- Active bacterial, fungal or viral infection not controlled by adequate treatment.
- Known HIV or hepatitis C virus (HCV) infection.
- Pregnant or nursing women may not participate.
- Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
- Previous treatment with any gene therapy products.
See the full eligibility criteria
- Age older than 6 months.
- Confirmed expression of CD7 or additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.
- Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate...
- Hgb≥80g/L.
- No cell separation contraindications.
- Abilities to understand and the willingness to provide written informed consent.
- Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
- Active bacterial, fungal or viral infection not controlled by adequate treatment.
- Known HIV or hepatitis C virus (HCV) infection.
- Pregnant or nursing women may not participate.
- Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
- Previous treatment with any gene therapy products.
- Patients, in the opinion of investigators, may not be able to comply with the 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, 6 months 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.