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New treatment option for B Cell Malignancies
Official title CD19/70 Bi-specific CAR-T Cell Therapy
ClinicalTrials.gov ID: NCT05436496
What this study is testing
What is bi-4SCAR CD19/70 T cells?
bi-4SCAR CD19/70 T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b cell malignancies.
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 study is to assess the feasibility, safety and efficacy of CD19/70 bi-specific CAR-T cell therapy in patients with CD19 and/or CD70 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/70 bi-specific CAR-T cells and their persistency in patients.
- 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.
- malignant B cell surface expression of CD19 or CD70 molecules.
- the KPS score over 80 points, and survival time is more than 1 month.
- greater than Hgb 80 g/L.
- no contraindications to blood cell collection.
You likely can't join if
- accompanied with other active diseases and difficult to assess patient response.
- bacterial, fungal, or viral infection, unable to control.
- living with HIV.
- active HBV or HCV infection.
- pregnant and nursing mothers.
- under systemic steroid treatment within a week of the treatment.
See the full eligibility criteria
- age older than 6 months.
- malignant B cell surface expression of CD19 or CD70 molecules.
- the KPS score over 80 points, and survival time is more than 1 month.
- greater than Hgb 80 g/L.
- no contraindications to blood cell collection.
- accompanied with other active diseases and difficult to assess patient response.
- bacterial, fungal, or viral infection, unable to control.
- living with HIV.
- active HBV or HCV infection.
- pregnant and nursing mothers.
- under systemic steroid treatment within a week of the treatment.
- prior failed CD19 and CD70 CAR-T treatment.
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.