Anti-CD38 Antibody Drug (STI-6129) for Multiple Myeloma

Not currently recruiting at 2 trial locations

Overseen By Mike Royal, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sorrento Therapeutics, Inc.

Must not be taking: Anticoagulants

Disqualifiers: Other malignancies, Neuropathy, Heart failure, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called STI-6129, an anti-CD38 antibody, to evaluate its effectiveness for people with multiple myeloma, a type of blood cancer that has returned or not responded to other treatments. The trial examines different doses to determine the safest and most effective amount. It targets individuals who have tried other treatments, such as certain cancer drugs, but still show measurable signs of the disease, like abnormal protein levels in their blood. This trial may suit those who have undergone multiple myeloma treatments without seeing results. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new drug.

Do I need to stop my current medications to join the trial?

The trial requires that you have not taken any systemic anti-tumor therapy or investigational drugs within 5 half-lives or 4 weeks before the first dose of the study drug, whichever is shorter. This means you may need to stop certain medications before joining, but the protocol does not specify all medications.

Is there any evidence suggesting that STI-6129 is likely to be safe for humans?

Studies have shown that STI-6129, the treatment being tested in this trial, is still under evaluation for safety. Previous research has not yet provided complete safety data. Since this trial is in its early stages, researchers closely monitor safety and side effects to determine the best dose for future studies.

STI-6129 is a drug designed to target multiple myeloma cells. So far, it has shown promise against cancer cells in lab tests. This is encouraging, but side effects and tolerability are still under study.

Prospective participants should know that researchers prioritize safety and will provide detailed information about potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the current treatments for multiple myeloma, which often include drugs like proteasome inhibitors and immunomodulatory agents, STI-6129 offers a unique approach. This treatment uses an anti-CD38 antibody, which specifically targets the CD38 protein found on the surface of multiple myeloma cells. By directly targeting CD38, STI-6129 aims to more effectively attack and eliminate cancer cells. Researchers are excited about STI-6129 because it could potentially improve treatment outcomes by providing a more focused attack on the disease, possibly with fewer side effects compared to broader-acting therapies.

What evidence suggests that STI-6129 might be an effective treatment for multiple myeloma?

Research has shown that STI-6129, a new drug, holds promise for treating multiple myeloma, particularly in patients whose cancer has returned or resisted other treatments. In lab studies, STI-6129 effectively targeted and killed cancer cells. The drug attaches to a protein on the surface of myeloma cells, potentially aiding the immune system in destroying these cancer cells. Although human trial data is limited, early results are encouraging and suggest potential benefits for patients with hard-to-treat multiple myeloma. ^{1 3 4 6 7}

Who Is on the Research Team?

Rajshekar Chakraborty, MD

Principal Investigator

Columbia University

David Kaminetzky, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with relapsed or refractory multiple myeloma who have tried other treatments, including a proteasome inhibitor and an anti-CD38 antibody. Participants must be in stable condition, able to perform daily activities (ECOG 0-2), and agree to use contraception. Excluded are those with significant heart issues, recent other cancers, severe infections like COVID-19 or hepatitis, certain blood disorders, or poor kidney function.

Inclusion Criteria

I am able to care for myself and perform daily activities.

Your oxygen level is at least 92% when measured with a pulse oximeter while breathing regular air.

You have abnormal levels of certain proteins in your blood or bone marrow.

Exclusion Criteria

I haven't taken any cancer drugs or experimental drugs within the last 4 weeks.

I had a stem cell transplant less than 6 months ago, have graft versus host disease, or am on immunosuppressive therapy post-transplant.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation Treatment

Participants receive STI-6129 intravenously once in a 4-week cycle during the dose-escalation stage to identify the recommended phase 2 dose (RP2D)

28-day cycle

1 visit per cycle (in-person)

Expansion Study

Participants continue to receive STI-6129 to assess preliminary efficacy in an expansion study

4-week cycle

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• STI-6129

Trial Overview The study tests STI-6129, an experimental drug given intravenously every four weeks to people whose multiple myeloma has not responded to standard treatments. It's a phase 1b/2a trial that gradually increases the dose of STI-6129 to find the safest and most effective level for patients.

How Is the Trial Designed?

Group I: STI-6129 Experimental Treatment 1 Intervention

Seven dosing cohorts will be evaluated: 0.67 mg/kg, 0.88 mg/kg, 1.18 mg/kg, 1.56 mg/kg, 2.08 mg/kg, 2.77 mg/kg, 3.68 mg/kg where STI-6129 will be intravenously administered once as part of a 4-week treatment cycle.

Who Is Running the Clinical Trial?

Sorrento Therapeutics, Inc.

Lead Sponsor

Trials

48

Recruited

2,000+

Published Research Related to This Trial

CD38 is a promising target for antibody therapy in various lymphoid tumors, including multiple myeloma, due to its strong presence on tumor cell surfaces.

Recent advancements in anti-CD38 antibodies have shown potent cytolytic effects against myeloma cells, with some antibodies also inhibiting CD38's cyclase activity, enhancing their therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD38 as a therapeutic target. Stevenson, GT.[2018]

SAR442085, a next-generation anti-CD38 monoclonal antibody, demonstrated superior binding affinity and enhanced antibody-dependent cellular cytotoxicity (ADCC) compared to first-generation antibodies like daratumumab and isatuximab in preclinical studies involving multiple myeloma cells.

In vivo studies using transgenic mice showed that SAR442085 resulted in better natural killer (NK) cell activation and improved antitumor efficacy, leading to increased survival rates compared to existing anti-CD38 therapies, supporting its potential for clinical evaluation in patients with relapsed/refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAR442085, a novel anti-CD38 antibody with enhanced antitumor activity against multiple myeloma. Kassem, S., Diallo, BK., El-Murr, N., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05565807

Safety and Efficacy Study of An Anti-CD38 Antibody Drug ... This is a phase Ib/IIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2020-06473

Study of the Safety and Efficacy of STI-6129 in Patients ... The STI-6129-001 study is a three-stage, multicenter, open-label, dose-finding, phase 1b/2a trial. It is designed primarily to identify the recommended ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20537620

Study to Assess Anti-CD38 Antibody Drug Conjugate in ... The purpose of this trial is to identify the RP2D of STI-6129 by assessing the safety, preliminary effectiveness and pharmacokinetics in ...

4. synapse.patsnap.com synapse.patsnap.com/article/advancements-in-multiple-myeloma-therapy-the-emergence-of-sti-6129-as-a-promising-anti-cd38-adc

The Emergence of STI-6129 as a Promising Anti-CD38 ADC STI-6129 has shown broad and potent in vivo anti-tumor efficacy in various xenograft models. Pharmacokinetic studies in Daudi-Fluc tumor-bearing ...

5. withpower.com withpower.com/trial/anti-cd38-antibody-drug-sti-6129-for-multiple-myeloma-6f456

Anti-CD38 Antibody Drug (STI-6129) for Multiple Myeloma This trial tests STI-6129, a new drug for multiple myeloma patients whose cancer has returned or not responded to other treatments.

6. sciencedirect.com sciencedirect.com/science/article/pii/S000649712106660X

A Phase 1, Open-Label, Dose-Escalation Study of the ... Importantly, STI-6129 has demonstrated cytotoxic activity in human multiple myeloma cells isolated from daratumumab-refractory patients (Figure ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10145905/

Antibody–Drug Conjugates for Multiple Myeloma STI-6129, also known as LNDS1001, is a fully human anti-CD38 antibody conjugated to Duostatin 5.2, an MMAF-derived microtubule inhibitor [67] ( ...