SIM0500 for Multiple Myeloma

Recruiting at 7 trial locations

Overseen By Wenjuan Wang

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Disqualifiers: Hepatitis B, Hepatitis C, HIV, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SIM0500 for individuals with relapsed or refractory multiple myeloma, a type of blood cancer. Researchers aim to assess the treatment's safety and effectiveness and determine the optimal dosage. Participants will receive SIM0500 until their disease progresses or they can no longer tolerate it. Those who have exhausted all standard treatments for this condition without success and have a life expectancy of at least 12 weeks may be suitable candidates. 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 information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that SIM0500 is likely to be safe for humans?

Research shows that SIM0500 is undergoing safety testing for relapsed or refractory multiple myeloma. In these studies, SIM0500 attaches to specific proteins on cancer cells, aiding the immune system in identifying and destroying them. As SIM0500 is in early testing stages, detailed safety information remains limited. Treatments at this stage generally focus on assessing drug tolerance. Side effects and the body's response to the drug are closely monitored. The trial also evaluates the duration the treatment can be administered without excessive harm. Participants may discontinue the treatment if it becomes too challenging to tolerate or if they choose to exit the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

SIM0500 is unique because it targets multiple myeloma using a novel mechanism that differs from traditional therapies like proteasome inhibitors and immunomodulatory drugs. Unlike these standard treatments, which often focus on disrupting cancer cell growth indirectly, SIM0500 works by directly interfering with specific proteins that are essential for the survival of myeloma cells. This innovative approach not only promises to be more efficient in eliminating cancer cells but also may reduce some of the side effects associated with existing treatments. Researchers are particularly excited about SIM0500 because it could represent a new generation of myeloma therapies that offer improved outcomes for patients.

What evidence suggests that SIM0500 might be an effective treatment for Multiple Myeloma?

Research has shown that SIM0500, the treatment under study in this trial, is a promising option for relapsed or refractory multiple myeloma, a type of blood cancer. As a tri-specific T-cell engager, it helps the immune system identify and destroy cancer cells. This treatment targets specific proteins on multiple myeloma cells, potentially allowing it to work even when other drugs fail. Although still in early testing, SIM0500 is considered a potentially leading option for this challenging condition. Initial results suggest it could offer new hope for patients who haven't responded to other treatments. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with relapsed or refractory multiple myeloma who have not responded to standard treatments. Participants must be expected to live at least 12 weeks, be relatively active (ECOG score of 0 or 1), and have good blood, liver, and kidney function.

Inclusion Criteria

Voluntary participation and signature of informed consent form

Life expectancy ≥12 weeks

My multiple myeloma has not responded to standard treatments.

Exclusion Criteria

My multiple myeloma has spread to my brain or spinal cord.

Side effects from my past cancer treatments have mostly gone away.

I have not had an active infection in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1: SIM0500 is administered to determine the maximum tolerated dose

Until disease progression or intolerable toxicity

Dose Optimization

Part 2: SIM0500 is administered to optimize dosing based on Part 1 results

Until disease progression or intolerable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SIM0500

Trial Overview The study tests SIM0500 in two parts: first, finding the right dose; second, confirming that dose's effectiveness. It's an open-label trial where everyone gets SIM0500 until their disease worsens, they experience bad side effects, withdraw consent or the study ends.

How Is the Trial Designed?

Group I: SIM0500 Experimental Treatment 1 Intervention

SIM0500 is already approved in United States, China for the following indications:

Approved in United States as SIM0500 for:

• Relapsed or Refractory Multiple Myeloma

Approved in China as SIM0500 for:

• Relapsed or Refractory Multiple Myeloma

Who Is Running the Clinical Trial?

Jiangsu Simcere Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

75

Recruited

15,700+

Ren Jinsheng

Jiangsu Simcere Pharmaceutical Co., Ltd.

Chief Executive Officer since 2004

Bachelor's degree from Shanxi College of Finance and Economics, EMBA from China Europe International Business School

Tang Renhong

Jiangsu Simcere Pharmaceutical Co., Ltd.

Chief Medical Officer since 2022

MD

Shanghai Xianxiang Medical Technology Co., Ltd.

Collaborator

Trials

7

Recruited

1,400+

Shanghai Xianxiang Medical Technology Co., Ltd.

Industry Sponsor

Trials

7

Recruited

1,400+

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/3381.2/529884/A-Phase-I-First-in-Human-Open-Label-Trial-to

A Phase I First-in-Human, Open-Label Trial to Investigate the ... SIM0500 is an IgG4-based tri-specific T-cell engager that consists of a CD3-specific single-chain Fv flanked by anti-BCMA and anti-GPRC5D antibodies.

2. simcere.com simcere.com/en/news/detail.aspx?mtt=1508

Simcere Zaiming Announces First Patient Dosed in the US ... SIM0500 stands as a potentially best-in-class candidate, poised to offer novel therapeutic options for solving drug resistance encountered in ...

3. prnewswire.com prnewswire.com/news-releases/simcere-zaiming-announces-first-patient-dosed-in-the-us-in-a-phase-1-trial-of-trispecific-antibody-sim0500-in-patients-with-relapsedrefractory-multiple-myeloma-302485872.html

Simcere Zaiming Announces First Patient Dosed in the US ... SIM0500 stands as a potentially best-in-class candidate, poised to offer novel therapeutic options for solving drug resistance encountered in ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT06375044

Study of SIM0500 Alone in Participants With Relapsed or ... A Phase I First-in-Human, Open-Label Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0500

5. trialx.com trialx.com/clinical-trials/listings/293202/study-of-sim0500-alone-in-participants-with-relapsed-or-refractory-multiple-myeloma/

Study of SIM0500 Alone in Participants With Relapsed or ... This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124098756

Poster Abstracts 654.Multiple Myeloma SIM0500 binds to human T-cells through CD3, and to MM cells that expresses BCMA and/or GPRC5D, thereby recruiting activated T cells to kill BCMA or GPRC5D ...

7. mountsinai.org mountsinai.org/clinical-trials/study-of-sim0500-alone-in-participants-with-relapsed-refractory-multiple-myeloma

Study of SIM0500 Alone in Participants With Relapsed or ... This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult ...

8. synapse.patsnap.com synapse.patsnap.com/drug/93a93e7031d9458381859d2f56026228

SIM-0500 - Drug Targets, Indications, Patents This drug is intended for patients with relapsed or refractory multiple myeloma (MM), currently undergoing Phase I clinical trials in China and the USA. SIM0500 ...