What is the mechanism of action of this treatment?

The most common treatments for Multiple Myeloma include proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), and monoclonal antibodies (e.g., daratumumab). Proteasome inhibitors work by blocking the proteasome's function, leading to the accumulation of proteins within the cancer cells, which induces cell death. Immunomodulatory drugs enhance the immune system's ability to fight cancer by stimulating T cells and inhibiting angiogenesis. Monoclonal antibodies target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. These mechanisms are crucial as they directly target the cancer cells, reduce tumor burden, and improve patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as combinations involving carfilzomib, pomalidomide, dexamethasone, bortezomib, and bendamustine, are associated with several side effects. The most frequently reported adverse events include fatigue, infections, neuropathy, gastrointestinal issues (such as diarrhea and constipation), and hematologic toxicities like neutropenia, thrombocytopenia, and anemia. Other notable side effects can include hypertension, cardiac events, and renal failure. These side effects vary in severity, with some reaching grade 3 or 4 levels, necessitating careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Multiple Myeloma, particularly for relapsed or refractory cases. Lenalidomide (Revlimid) and bortezomib (Velcade) are commonly used, often in combination with dexamethasone. Daratumumab (Darzalex), a monoclonal antibody targeting CD38, has also been approved and is frequently used in combination therapies. These drugs have shown efficacy in prolonging progression-free survival and overall survival in multiple myeloma patients.

What other types of research exist?

Promising novel alternatives to STI-1492 for Multiple Myeloma patients include: 1) NPI-0052 (marizomib), a novel proteasome inhibitor that has shown sustained proteasome inhibition and antitumor activity in preclinical models. 2) CC-90002, an anti-CD47 therapeutic antibody that modulates the CD47-SIRPα innate immune checkpoint axis and has demonstrated potential activity in hematological malignancies. 3) Peptide agonists targeting the c-Mpl receptor, which have shown high activity in human CD34(+) primary cell cultures and increased blood platelet counts in mice.

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CAR T-cell Therapy

Anti-CD38 A2 DAR T Cells for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Sorrento Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments

Evidence of cell membrane CD38 expression as determined by immunohistochemistry (IHC) analysis of bone marrow biopsy or extramedullary plasmacytoma

Must not have

Has active plasma cell leukemia

A history of brain metastasis or spinal cord compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through study completion at up to approximately 54 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called STI-1492 for patients whose multiple myeloma has returned or not responded to other treatments. The drug is given through an IV, and the dose is gradually increased to find the safest and most effective amount.

Who is the study for?

This trial is for adults with relapsed or refractory multiple myeloma who've had previous treatments, can follow the study plan and contraception rules, have CD38 expression in their cancer cells, a life expectancy of at least 12 weeks, measurable disease levels, and good oxygen levels without assistance.

What is being tested?

The trial tests STI-1492, an experimental therapy involving anti-CD38 T cells. It's given once through the vein to see how safe it is and what dose works best for people whose multiple myeloma has come back or didn't respond to treatment.

What are the potential side effects?

Potential side effects are not specified but may include typical reactions related to immune cell infusions such as fever, fatigue, allergic reactions. Since this is an early-phase trial assessing safety and dosage, close monitoring will occur for any unexpected adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My multiple myeloma has returned or didn't respond after treatment.

Select...

My cancer shows CD38 on the cell surface.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have active plasma cell leukemia.

Select...

I have had cancer spread to my brain or spine.

Select...

My heart's pumping ability is below 40%.

Select...

I haven't had any systemic therapy for my multiple myeloma in the last 14 days.

Select...

My blood clotting tests are abnormal, but I am on a stable dose of blood thinner.

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I have HIV/AIDS or chronic hepatitis B or C.

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I do not have any major health or mental issues preventing me from joining the study.

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I have another cancer besides multiple myeloma that is either not in remission or was treated in the last 3 years.

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I currently have an infection.

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I had a stem cell transplant less than 6 months ago, have GvHD, or am on immunosuppressants.

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I have a tumor outside of my bone marrow.

Select...

I have no lasting side effects from cancer treatment worse than Grade 2.

Select...

I need help with my daily activities due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through study completion at up to approximately 54 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through study completion at up to approximately 54 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion at up to approximately 54 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of STI-1492

Secondary study objectives

Assessment of improvements in hypercalcemia, renal function, anemia and lytic bone lesions (CRAB criteria)

Assessment of serum immunoglobulin levels

Overall response and duration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: STI-1492Experimental Treatment1 Intervention

Four dosing cohorts will be evaluated: Cohort 1 (1 × 10\^5 donor DAR-T cells/kg); Cohort 2 (5 × 10\^5 donor DAR-T cells/kg); Cohort 3 (1 × 10\^6 donor DAR-T cells/kg); Cohort 4 (3 × 10\^6 donor DAR-T cells/kg) where STI-1492 will be administered intravenously once.

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple Myeloma include proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), and monoclonal antibodies (e.g., daratumumab). Proteasome inhibitors work by blocking the proteasome's function, leading to the accumulation of proteins within the cancer cells, which induces cell death. Immunomodulatory drugs enhance the immune system's ability to fight cancer by stimulating T cells and inhibiting angiogenesis. Monoclonal antibodies target specific proteins on the surface of myeloma cells, marking them for destruction by the immune system. These mechanisms are crucial as they directly target the cancer cells, reduce tumor burden, and improve patient outcomes.