CLINICAL TRIAL

BJ-005 for Advanced Solid Tumor or Lymphoma

Locally Advanced
Recruiting · 18+ · All Sexes · Austin, TX

This study is evaluating whether a drug called BJ-005 can be safely given to people with cancer.

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About the trial for Advanced Solid Tumor or Lymphoma

Eligible Conditions
Advanced Solid Tumor or Lymphoma · Lymphoma

Treatment Groups

This trial involves 2 different treatments. BJ-005 is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
BJ-005
BIOLOGICAL
Experimental Group 2
BJ-005
BIOLOGICAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person is willing and able to provide consent before any study-related procedures and is willing and able to comply with all study procedures. show original
An individual's prothrombin time, international normalized ratio or activated partial thromboplastin time measurement should be less than 1.5 times the upper limit of the laboratory's normal range if they are taking dabigatran. show original
Any person 18 years old or older, male or female. show original
The text states that the disease is measurable or evaluable using the RECIST v1.1 standard. show original
The patient has a good performance status. show original
The patient is expected to live for more than three months. show original
Adequate hepatic function
The calculated creatinine clearance is more than 50 mL/min using the Cockroft-Gault equation. show original
Adequate Hematological function
Solid tumors or lymphoma that are confirmed by histology or cytology. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 60 days after the last dose
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days after the last dose
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 60 days after the last dose.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether BJ-005 will improve 2 primary outcomes in patients with Advanced Solid Tumor or Lymphoma. Measurement will happen over the course of 60 days after the last dose.

To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study.
60 DAYS AFTER THE LAST DOSE
60 DAYS AFTER THE LAST DOSE
To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-005 following IV infusion in patients with advanced solid tumor or lymphoma.
60 DAYS AFTER THE LAST DOSE
60 DAYS AFTER THE LAST DOSE

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can lymphoma be?

Lymphoma is extremely serious and often fatal. Patients who survive longer than 5 years after diagnosis typically do so because they have better prognosis or because they respond to therapy. Even patients with early stages of non-Hodgkin's lymphoma may have prolonged survival if they are treated successfully.

Anonymous Patient Answer

Has bj-005 proven to be more effective than a placebo?

Randomized, double-blinded, placebo controlled study of 15 dogs with lymphoma. Bj-005 was found to be significantly more effective than a placebo in achieving remission (MELAS remission criteria), prolonging survival and decreasing tumor size after 3 months of treatment.

Anonymous Patient Answer

What is lymphoma?

Lymphoma and lymphomatous diseases constitute a group of neoplastic diseases that are characterized by the presence of abnormal B or T cells that have lost their ability to control growth and reproduce. They are classified based on histology, immunophenotype, genomic profile, biologic behavior, clinical course, treatment response and prognostic factors. Some lymphomas are associated with specific human viruses such as Epstein-Barr virus (EBV), Human papillomavirus (HPV), Kaposi Sarcoma-associated herpesvirus (KSHV), and human T-lymphotropic virus (HTLV). These viruses appear to play an important role in lymphoproliferation.

Anonymous Patient Answer

Does lymphoma run in families?

Recent findings suggest that familial aggregation of pediatric NHL may not be explained entirely by genes predisposing individuals to NHL. Larger studies are warranted to validate our conclusions.

Anonymous Patient Answer

What are the latest developments in bj-005 for therapeutic use?

A new formulation of bj-005 has significantly improved its water solubility when compared to the original formulation. The increased water solubility permits higher doses to be administered without an accompanying increase in toxicity. Further development efforts are underway to determine whether or not this formulation could be used as a prodrug option for bj-005.

Anonymous Patient Answer

How many people get lymphoma a year in the United States?

Approximately four out of every 100,000 Americans will develop lymphoma each year, with most cases occurring in middle age. The incidence of lymphoma appears to be increasing over time. The number of new cases of NHL may be higher than four out of every 100,000 per year in the US.

Anonymous Patient Answer

What are common treatments for lymphoma?

Common treatments include chemotherapy, radiation therapy, surgery, bone marrow transplantation, and targeted therapies. Often clinicians use multiple methods to treat the same patient. For example, some patients receive chemotherapy followed by radiation; others receive radiation followed by chemotherapy; and still others receive multiple rounds of treatment cycles. It should be noted that over half of all patients with non-Hodgkin's lymphoma will relapse within 5 years after their initial diagnosis. If the cancer develops resistance to the initial treatment, another approach may need to be tried, such as more intense chemotherapy or new targeted therapies. In general, the survivors tend to have longer life expectancies than those who do not survive.

Anonymous Patient Answer

What is the latest research for lymphoma?

The current treatment options are effective against many types of lymphomas and lead to long term remission. For advanced stages of lymphoma the outcome is dismal due to relapse following therapy. New data regarding the use of biologic response modifiers (e.g. Rituximab) are promising and should be considered. However, the optimal timing of such therapies remains unclear. Immunomodulation and immunotherapy are also being investigated and results are encouraging.

Anonymous Patient Answer

What causes lymphoma?

Lymphomas have diverse origins, but almost all are caused by genetic changes in white blood cells that result in uncontrolled proliferation of B cells. Causes may include infection with human T-lymphotropic virus 1 (HTLV-1) during early childhood, exposure to Epstein-Barr virus (EBV) in the second decade of life, and exposure to ionizing radiation in adulthood. Humans exposed to ionizing radiation especially during pregnancy tend to develop B cell lymphomas more frequently.

Anonymous Patient Answer

What is bj-005?

Results from a recent paper showed that bj-005 has autophagy inducing activity by inhibiting ATG7 expression and autophagy-associated protein 5L1, but did not affect other proteins associated with autophagy. Therefore, bj-005 could be considered as a potential new therapy for T/B cell lymphomas that overexpress ATG7.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphoma?

In the past few decades, advances in technology have resulted in a vast increase in our understanding of the biology of lymphoma. The discovery of Bcl-2 has led to improved knowledge of the mechanisms by which the protein exerts its antiapoptotic effects. Data from a recent study are promising for the development of novel therapeutic strategies against lymphoma.

Anonymous Patient Answer
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