LBS-007 for Acute Leukemia

Recruiting at 14 trial locations

Overseen By Lin BioScience Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Lin BioScience, Inc

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: CNS involvement, Other malignancy, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment called LBS-007 for certain types of acute leukemia, specifically acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). The main goals are to assess the safety of LBS-007, determine how well participants tolerate it, and identify the optimal dose. The trial also evaluates the treatment's effectiveness and how the body processes it. Suitable candidates are those with AML or ALL that have not responded to other treatments and lack other viable options. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial requires that you do not take other chemotherapy, radiation therapy, or immunotherapy while participating. If you are on these treatments, you will need to stop them before joining the trial.

Is there any evidence suggesting that LBS-007 is likely to be safe for humans?

Research is examining the safety and tolerability of LBS-007 for individuals with acute leukemia. Earlier studies have focused on identifying the safest dose of LBS-007. The aim is to determine its safety and effectiveness in treating types of leukemia, such as acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), that have returned or do not respond to other treatments.

The FDA has granted this treatment fast track status, indicating promise in early safety tests. Fast track status is often awarded to treatments that may be safer or more effective than current options and address an unmet medical need. While this is encouraging, LBS-007 is still under study to confirm these findings in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for acute leukemia, which often involve chemotherapy and targeted therapies like Venetoclax and Azacitidine, LBS-007 offers a fresh approach. Researchers are excited about LBS-007 because it introduces a novel mechanism of action, which could work synergistically with existing treatments to enhance effectiveness. This potential to combine with current therapies and optimize dosing makes LBS-007 a promising candidate for improving patient outcomes.

What evidence suggests that LBS-007 might be an effective treatment for acute leukemia?

Research shows that LBS-007 targets a protein called CDC7, which plays a key role in cell growth and division. By targeting this protein, LBS-007 can halt cancer cell growth and lead to their death. In early lab tests, this treatment showed promise against cancer cells unresponsive to chemotherapy. LBS-007 also proved effective in cases with a change in the p53 gene, a common issue in leukemia. These early findings suggest that LBS-007 might effectively treat acute leukemia, particularly acute myeloid leukemia (AML). Participants in this trial will receive LBS-007 either as a monotherapy or in combination with Venetoclax and Azacitidine during the dose-finding and expansion phases. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed or resistant acute leukemias like AML or ALL, who can't have standard treatments anymore. They should be relatively active and able to do light activities (ECOG status 0-2).

Inclusion Criteria

My leukemia has come back or didn't respond to treatment.

I am over 18 years old.

I have no standard treatment options left that could cure or significantly control my disease.

Exclusion Criteria

I have leukemia affecting my brain or spinal cord.

I am not currently receiving chemotherapy, radiation, or immunotherapy.

Receiving any other investigational agents concurrently or within 30 days prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Finding

Phase 1: Dose finding phase to evaluate LBS-007 as a monotherapy and combination with Venetoclax and Azacitidine

Variable duration

Dose Expansion

Phase 2: Dose expansion phase to evaluate LBS-007 as a monotherapy and combination therapy at the optimal dose identified by phase 1

Variable duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LBS-007

Trial Overview The study tests the safety and maximum tolerated dose of a new drug called LBS-007 in patients with acute leukemia. It also looks at how well it works and measures how the body processes it.

How Is the Trial Designed?

Group I: Dose Finding and Expansion Phase Experimental Treatment 1 Intervention

Phase 1: Dose finding phase to evaluate LBS-007 as a monotherapy and combination with Venetoclax and Azacitidine Phase 2: Dose expansion phase to evaluate LBS-007 as a monotherapy and combination therapy at the optimal dose identified by phase 1 (dose finding)

LBS-007 is already approved in United States for the following indications:

Approved in United States as LBS-007 for:

• Acute Lymphoblastic Leukemia (ALL)
• Acute Myeloid Leukemia (AML)

Who Is Running the Clinical Trial?

Lin BioScience, Inc

Lead Sponsor

Trials

1

Recruited

90+

Lin BioScience Pty Ltd

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

The B7-1 vaccine, developed by introducing the B7-1 gene into L615 leukemic cells, showed promise in inducing an immune response against leukemic cells, as evidenced by the selection of a highly expressing clone (L615-B7).

In vitro studies demonstrated that L615-B7 cells enhanced T cell functions, including cytotoxicity, proliferation, and growth factor secretion, indicating a potential mechanism for the vaccine's immunoprotective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experimental study of anti-tumor immunity induced by B7 vaccine of a highly malignant murine leukemic T cell line (L615)]. Li, M., You, S., Liao, X.[2017]

In a study of 30 untreated adult patients with CD7 positive acute myeloid leukemia (CD7+ AML), it was found that these patients often exhibited higher levels of leukocytosis and were more likely to express CD34 and P-glycoprotein.

Only 42.3% of CD7+ AML patients achieved complete remission, with a median remission duration of just 4 months, indicating a poorer prognosis compared to other AML subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Immunophenotype and P-glycoprotein expression in CD7 positive adult acute myeloid leukemia]. Hua, D., Li, J., Xia, X.[2018]

The BRD7 gene is significantly up-regulated in bone marrow mononuclear cells from patients with acute leukemia, suggesting its potential role in the disease's pathology.

Two specific single nucleotide polymorphisms (C495T and A737G) in the BRD7 gene are associated with acute leukemia, indicating that these genetic variations may contribute to the susceptibility to the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Expression and SNP analysis of BRD7 gene in acute leukemia cells]. Tang, XY., Liu, F., Peng, Y., et al.[2008]

In a study of 410 acute leukemia patients, 7.8% exhibited abnormalities of chromosome 7, with the most common being -7/7q-; this anomaly was particularly prevalent in certain subtypes of acute myeloid leukemia (M0, M1, and M2).

Patients with chromosome 7 anomalies had a lower complete remission rate (36.7%) after chemotherapy compared to the overall acute leukemia population (65.8%), indicating that these chromosomal abnormalities are linked to a poorer prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of 32 cases of acute leukemia with abnormality of chromosome 7]. Lu, Y., Jin, J., Chen, ZM., et al.[2015]

Interleukin 7 (IL-7) significantly enhances the expression of B7-1 and B7-2 molecules on acute leukemia (AL) cells, which are important for immune response, indicating a potential mechanism for improving immunogenicity in leukemia treatment.

IL-7-treated leukemia cells can stimulate the proliferation of allogeneic peripheral blood mononuclear cells (PBMNC) and increase their production of interferon-gamma (IFN-gamma), suggesting that IL-7 may enhance the immune response against leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Study on the up-regulation of B7 molecules expression and immunogenicity of acute leukemia cells induced by interleukin 7]. Qian, WB., Lin, MF.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05756322

The Safety and Tolerability of LBS-007 in Patients With ... Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement. History of another active malignancy with 2 years prior to study entry ...

2. onclive.com onclive.com/view/fda-awards-fast-track-designation-to-lbs-007-for-acute-myeloid-leukemia

FDA Awards Fast Track Designation to LBS-007 for Acute ... Key Takeaways · LBS-007 targets CDC7 in cell cycle regulation, showing preclinical efficacy against chemotherapy-resistant cancer cell lines.

3. targetedonc.com targetedonc.com/view/fda-grants-fast-track-designation-to-lbs-007-in-aml

FDA Grants Fast Track Designation to LBS-007 in AML By inhibiting CDC7, a crucial regulator of the cell cycle, LBS-007 effectively halts tumor cell proliferation and induces cell death. This ...

4. linbioscience.com linbioscience.com/_Files/Company/C2C5A5EF51A6670DB4FC258C275262BA/Lin%20Bioscience%20-%20Company%20Presentation%20EN%20202507.pdf

Bringing Hope to Incurable Diseases ✓ 2024/10/05 - We announced that our new drug, LBS-007, for the treatment of acute leukemia has passed the US FDA IND review for human clinical ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123080266

Unraveling Novel Mechanisms for Targeting the Intra-S ... LBS-007 showed significant effectiveness in all three cases with altered p53 status and with GI 50 values comparable to those observed in wild- ...

6. ctsearchsupport.org ctsearchsupport.org/clinical-trials/the-safety-and-tolerability-of-lbs-007-in-patients-with-relapsed-or-resistant-acute-leukaemias

A drug, LBS-007, to treat acute lymphoblastic leukemia ... To find out:The highest dose of LBS-007 that's safe to giveIf LBS-007 is safe and works well to treat ALL or AML that has relapsed or is refractory.