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

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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests STI-6129, a new drug for multiple myeloma patients whose cancer has returned or not responded to other treatments. The drug is given through an IV periodically to find the best dose and check its safety and effectiveness.

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.

What data supports the effectiveness of the drug STI-6129 for treating multiple myeloma?

Research shows that targeting CD38, a molecule found on many myeloma cells, with antibodies can improve patient outcomes. Similar drugs, like SAR442085 and MOR202, have shown promising results in preclinical and early clinical trials, suggesting that STI-6129 may also be effective. ^{1 2 3 4 5}

Is the anti-CD38 antibody drug STI-6129 generally safe for humans?

CD38-targeting antibodies, like STI-6129, are generally well tolerated in humans, with the most common side effect being infusion-related reactions, which usually happen during the first treatment. These antibodies have been used safely in treating multiple myeloma and other blood-related cancers. ^{1 2 3 4 5}

How is the drug STI-6129 different from other treatments for multiple myeloma?

STI-6129 is an anti-CD38 antibody drug that targets the CD38 protein, which is highly expressed on multiple myeloma cells, making it a promising treatment option. Unlike some other treatments, it may offer a unique mechanism by inhibiting CD38's enzymatic activity and potentially delivering a toxin directly to tumor cells, enhancing its specificity and effectiveness against myeloma. ^{1 2 3 6 7}

Research Team

Rajshekar Chakraborty, MD

Principal Investigator

Columbia University

David Kaminetzky, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

CD38 as a therapeutic target. [2018]

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

Review: Effects of anti-CD38 monoclonal antibodies on red blood cell transfusion and interventions. [2022]

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

CD38 antibodies in multiple myeloma: back to the future. [2021]

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

MOR202, a novel anti-CD38 monoclonal antibody, in patients with relapsed or refractory multiple myeloma: a first-in-human, multicentre, phase 1-2a trial. [2020]

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

SAR442085, a novel anti-CD38 antibody with enhanced antitumor activity against multiple myeloma. [2022]

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

Novel Insights in Anti-CD38 Therapy Based on CD38-Receptor Expression and Function: The Multiple Myeloma Model. [2021]

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

Anti CD38 monoclonal antibodies for multiple myeloma treatment. [2022]