Actively Recruiting
Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia
Led by Beijing GoBroad Hospital · Updated on 2026-03-10
3
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if BiTE-EV works to treat relapsed/refractory acute B-cell leukemia in adults. It will also learn about the safety of BiTE-EV. The main questions it aims to answer are: Can BiTE-EV effectively treat relapsed/refractory acute B-cell lymphoblastic leukemia? What medical problems do participants have when taking BiTE-EV? Participants will: Take BiTE-EV every other day for 1 or 2 months Keep a diary of their symptoms during the medication period During the follow-up period, visit the clinic once every 4 weeks for checkups and tests
CONDITIONS
Official Title
Clinical Study on the Safety and Efficacy of BiTE-EV in Relapsed/Refractory Acute B-Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Diagnosed with relapsed or refractory acute B lymphocytic leukemia, including relapse after CAR-T treatment or transplantation, or when T cells cannot be used for CAR-T production
- Tumor cells test positive for CD19 antibody
- Expected survival longer than 3 months from consent date
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
- Heart function with ejection fraction over 50% and normal electrocardiogram
- Peripheral oxygen saturation of at least 92%
- Serum creatinine at or below 1.5 times the upper normal limit
- Liver enzymes (ALT, AST) at or below 5 times the upper normal limit and total bilirubin at or below 3 times the upper normal limit
- Agree to use contraception during the study and for six months after if pregnancy is possible
- Able to understand and sign informed consent form
You will not qualify if you...
- Uncontrolled diseases including persistent infections, symptomatic heart failure, unstable angina, arrhythmia, poorly controlled lung diseases, or mental disorders
- Presence of other active cancers
- Severe infections that cannot be controlled
- Positive for hepatitis B surface antigen or core antibody with detectable hepatitis B virus DNA
- Positive for hepatitis C virus antibody and RNA
- Positive for cytomegalovirus DNA or Epstein-Barr virus DNA in blood
- Positive for HIV or syphilis
- History of severe allergic reactions to biological products including antibiotics
- History of severe acute graft-versus-host disease after allogeneic stem cell transplant
- Pregnant or breastfeeding females
- Active autoimmune diseases requiring systemic immunosuppressive treatment
- Any condition that the investigator believes would increase risk or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jing Pan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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