BJ-005 for Solid Cancers and Lymphoma
Trial Summary
What is the purpose of this trial?
This trial is testing a new treatment called BJ-005 in patients with advanced cancers. BJ-005 helps the immune system attack cancer cells and blocks growth signals for these cells. The study aims to see if this treatment is safe and how it behaves in the body.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had anticancer therapy or radiation therapy within 5 half-lives or 4 weeks before joining the study.
What data supports the effectiveness of the drug BJ-005 for solid cancers and lymphoma?
While there is no direct data on BJ-005, research on similar treatments like ibrutinib, a Bruton's tyrosine kinase inhibitor, shows it has been effective in treating various B-cell lymphomas by improving tumor response rates and survival. This suggests that targeting similar pathways could be beneficial for lymphoma treatment.12345
What safety data exists for BJ-005 (Brucea javanica oil) in humans?
Brucea javanica oil (BJO) has been used clinically in China for treating various cancers, including leukemia and lung cancer, with studies showing it has low toxicity in healthy human cells. It has been shown to have minimal harmful effects on healthy blood cells while effectively targeting cancer cells.678910
How does the drug BJ-005 differ from other treatments for solid cancers and lymphoma?
BJ-005, also known as ibrutinib, is unique because it targets a specific protein called Bruton's tyrosine kinase (BTK), which plays a role in the growth of certain cancer cells. This makes it different from traditional chemotherapy, as it specifically disrupts cancer cell signaling pathways, potentially leading to better outcomes in certain types of lymphomas.24111213
Research Team
Vicky Gao, MD
Principal Investigator
BJ Bioscience, Inc.
Eligibility Criteria
This trial is for adults over 18 with advanced solid tumors or lymphoma who have recovered from previous cancer treatments. They must be able to consent, have a life expectancy of at least 3 months, and meet certain health criteria like good liver function and no severe heart issues. People with prior PD-L1/TGFβRⅡ treatment, active infections including HIV/HBV/HCV, recent anticancer therapy, pregnancy, autoimmune diseases, or uncontrolled hypertension cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of BJ-005 to evaluate safety and tolerability
Cohort Expansion
Participants receive BJ-005 at the determined safe dose to further evaluate pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BJ-005
Find a Clinic Near You
Who Is Running the Clinical Trial?
BJ Bioscience, Inc.
Lead Sponsor