BJ-005 for Solid Cancers and Lymphoma

Recruiting at 5 trial locations

Overseen By Joe Zhang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BJ Bioscience, Inc.

Disqualifiers: CNS tumor, Hypertension, Cardiovascular, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

85 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 4 11 12 13}

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

My kidney function, measured by creatinine clearance, is good.

Measurable or evaluable disease per RECIST v1.1

My cancer diagnosis was confirmed through tissue or cell testing.

Exclusion Criteria

I have a serious heart condition.

I have active tuberculosis.

I have an active HIV, hepatitis B, or hepatitis C infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of BJ-005 to evaluate safety and tolerability

8-12 weeks

Cohort Expansion

Participants receive BJ-005 at the determined safe dose to further evaluate pharmacokinetics

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BJ-005

Trial Overview The study tests BJ-005 in patients for the first time. It's a Phase 1 trial focusing on safety and how the body processes the drug. BJ-005 is an experimental molecule combining an anti-PD-L1 antibody with part of TGF-β receptor II aimed at treating advanced cancers.

Participant Groups

Group I: Arm1 Experimental Treatment 1 Intervention

BJ-005 dose escalation

Group II: Arm 2 Experimental Treatment 1 Intervention

BJ-005 cohort expansion

Who Is Running the Clinical Trial?

BJ Bioscience, Inc.

Lead Sponsor

Trials

2

Recruited

180+

Findings from Research

Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has shown promising results in early-phase clinical studies for patients with indolent B-cell lymphomas, leading to increased tumor response rates and significant improvements in survival.

The FDA has designated ibrutinib as a 'breakthrough therapy' for treating relapsed or refractory mantle cell lymphoma and Waldenström macroglobulinemia, highlighting its potential as a novel treatment option in these hematological malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib and indolent B-cell lymphomas. Akinleye, A., Furqan, M., Adekunle, O.[2021]

In a phase Ib study involving 18 patients with primary CNS lymphoma (PCNSL), 94% experienced tumor reductions with ibrutinib monotherapy, highlighting its efficacy, especially in patients with specific mutations (CD79B and MYD88) that enhance B cell receptor signaling.

While ibrutinib showed promising results in reducing tumors and enhancing chemotherapy effectiveness, there was an increased risk of aspergillosis, a fungal infection, indicating a potential safety concern linked to impaired fungal immunity due to BTK inhibition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of B Cell Receptor Signaling by Ibrutinib in Primary CNS Lymphoma. Lionakis, MS., Dunleavy, K., Roschewski, M., et al.[2022]

Ibrutinib treatment showed a high overall response rate of 75% in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL), with a median progression-free survival of 4 months, indicating its efficacy in this aggressive cancer type.

Genomic analysis revealed that patients with simpler genetic variants and lower tumor mutation burdens (TMB) responded better to ibrutinib, suggesting that genomic profiling could help predict treatment outcomes and tailor therapies for CNS lymphoma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcome of ibrutinib-based regimens in relapsed/refractory central nervous system lymphoma and the potential impact of genomic variants. Wang, S., Zhu, Y., Qian, X., et al.[2023]

A combination treatment of temozolomide, etoposide, doxorubicin, dexamethasone, rituximab, and the BTK inhibitor ibrutinib showed promising responses in patients with primary central nervous system lymphoma.

However, this treatment regimen was linked to significant toxicity, including serious infections like pulmonary and cerebral aspergillosis, highlighting the need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib in PCNSL: The Curious Cases of Clinical Responses and Aspergillosis. Grommes, C., Younes, A.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Open-Label, Multicenter, Phase I/II Study of JNJ-40346527, a CSF-1R Inhibitor, in Patients with Relapsed or Refractory Hodgkin Lymphoma. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Ibrutinib and indolent B-cell lymphomas. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Intensive, very short-term chemotherapy for advanced Burkitt's lymphoma in children. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Ibrutinib as a treatment of hematologic autoimmune disorders in patients with indolent B-cell lymphoma. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Bruton's tyrosine kinase inhibitors and their clinical potential in the treatment of B-cell malignancies: focus on ibrutinib. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Brucea javanica oil alleviates intestinal mucosal injury induced by chemotherapeutic agent 5-fluorouracil in mice. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Seed Oil of Brucea javanica Induces Apoptotic Death of Acute Myeloid Leukemia Cells via Both the Death Receptors and the Mitochondrial-Related Pathways. [2022]

8. China pubmed.ncbi.nlm.nih.gov

[Meta-analysis on treatment of non-small cell lung cancer with brucea javanica oil emulsion in combination with platinum-contained first-line chemotherapy]. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial. [2022]

10. China pubmed.ncbi.nlm.nih.gov

[Inhibitory effect of Biejiajian pills against diethylnitrosamine-induced hepatocarcinogenesis in rats]. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Inhibition of B Cell Receptor Signaling by Ibrutinib in Primary CNS Lymphoma. [2022]

12. Poland pubmed.ncbi.nlm.nih.gov

The outcome of ibrutinib-based regimens in relapsed/refractory central nervous system lymphoma and the potential impact of genomic variants. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Ibrutinib in PCNSL: The Curious Cases of Clinical Responses and Aspergillosis. [2018]