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Tests treatment safety and results for Relapsed or Refractory B-cell Acute Lymphoblastic...
Official title A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.
ClinicalTrials.gov ID: NCT06927466
What this study is testing
What is B019?
B019 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory b-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 the study is to evaluate the safety and tolerability of B019 in subjects.
- 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
Ages 3 to 25
You may be able to join if
- The patient himself/herself , and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form；
- Meet the diagnostic criteria for recurrent or refractory acute B cell lymphoblastic leukemia；
- Documentation of CD19/CD22 tumor expression 3\. Liver, kidney, lung and heart function meet requirements; 4. Expected survival \>3 months; 5. Women...
You likely can't join if
- Active CNS involvement by malignancy；
- Isolated extramedullary leukemia recurrence；
- people with ≥grade 2 acute or moderate to severe chronic graft-versus-host disease (GVHD) within 4 weeks prior to screening;
- Has had treatment with any prior CAR-T therapy or other therapy abandoned in protocal. 4\. people who received therapy abandoned in protocal before...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Nanchang, China
- Shanghai, China
- Suzhou, China
- Wuhan, China
- Xuzhou, 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, 3 years to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Nanchang, China; Shanghai, China; Suzhou, China; Wuhan, China; Xuzhou, 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.