BMS-986453 for Multiple Myeloma

Recruiting at 38 trial locations

Overseen By First line of the email MUST contain the NCT# and Site#

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Disqualifiers: CNS involvement, Plasma cell leukemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Variable, based on dose-finding

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BMS-986453 for individuals with multiple myeloma, a type of blood cancer that has returned or not responded to other treatments. The study aims to evaluate the effectiveness and safety of this treatment. It seeks participants whose multiple myeloma worsened after their last treatment and who have tried other cancer drugs. Participants should not have serious brain issues or specific blood-related diseases. 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 this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 BMS-986453 is likely to be safe for humans?

Research shows that BMS-986453 remains in the early stages of testing. In Phase 1, the treatment is being tried in humans for the first time. The main goal is to determine if BMS-986453 is safe and to identify any side effects.

Currently, limited information exists about its safety for humans. This phase helps researchers gather crucial safety details, looking for any unexpected or harmful effects. As a new treatment, there is not much data yet on how well people tolerate it.

Overall, because BMS-986453 is in Phase 1, researchers are carefully checking the treatment for safety issues. Participants in these trials receive close monitoring to ensure their safety as researchers learn more about the treatment's effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BMS-986453 is unique because it offers a novel approach to treating multiple myeloma by targeting specific pathways that current treatments may not address. Unlike traditional therapies like proteasome inhibitors and immunomodulatory drugs, BMS-986453 potentially employs a different mechanism of action to disrupt cancer cell growth. Researchers are excited about this treatment because it could provide an option for patients who do not respond well to existing therapies, potentially improving outcomes and offering hope for a more personalized treatment approach.

What evidence suggests that BMS-986453 might be an effective treatment for multiple myeloma?

Research has shown promising results for BMS-986453 in treating relapsed and/or refractory multiple myeloma (RRMM). In earlier studies with similar treatments, 88% of patients responded positively, and 45% experienced complete tumor shrinkage or disappearance. Participants in this trial will receive BMS-986453, which remains in the early stages of evaluation. Although risks exist, as one patient in a related study died due to the treatment, the potential benefits are significant. This treatment offers hope as a new option for those whose previous treatments have not worked. ^{1 2 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with multiple myeloma that has come back or didn't respond to treatment. They should have tried at least three prior treatments, including a proteasome inhibitor and an immunomodulatory agent, and seen their disease progress within a year of the last treatment. Good organ function and physical ability (ECOG status 0 or 1) are required.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I have had at least 3 treatments for myeloma, including specific types of medication.

My cancer worsened within 12 months after my last myeloma treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986453, a dual targeting BCMAxGPRC5D chimeric antigen receptor T cell therapy

Variable, based on dose-finding

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986453

Trial Overview The study tests BMS-986453 in those with relapsed/refractory multiple myeloma. Participants will also receive Fludarabine and Cyclophosphamide as part of the treatment regimen to evaluate the effectiveness and safety of BMS-986453.

How Is the Trial Designed?

Group I: Administration of BMS-986453 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Lead Sponsor

Trials

19

Recruited

3,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06153251

NCT06153251 | A Study to Assess BMS-986453 in ... Study Overview​​ The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).

2. oncologypipeline.com oncologypipeline.com/apexonco/bristol-makes-quick-pivotal-move-multiple-myeloma

Bristol makes a quick pivotal move in multiple myeloma In phase 1 BMS-986393 yielded an 88% ORR and 45% CR rate – better than Talvey on a cross-trial basis – though one patient died from drug-related ...

3. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/bms-986453-bristol-myers-squibb-relapsed-multiple-myeloma-likelihood-of-approval/

BMS-986453 by Bristol-Myers Squibb for Relapsed ... According to GlobalData, Phase I drugs for Relapsed Multiple Myeloma have a 78% phase transition success rate (PTSR) indication benchmark for ...

4. ashpublications.org ashpublications.org/blood/article/146/5/535/536609/A-phase-1-trial-of-fully-human-BCMA-CAR-T-therapy

A phase 1 trial of fully human BCMA CAR-T therapy for ... Key PointsFCARH143 achieved a 100% ORR, with 68% stringent complete response and a median PFS of 15.5 months at 67.3 months follow-up.

5. patientpower.info patientpower.info/multiple-myeloma/what-data-supports-car-t-in-pretreated-myeloma

What Data Supports CAR T in Pretreated Myeloma? The overall response rate was 75.8% of patients achieving a partial or complete response. 64.5% achieved a very good partial response or better.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0006497125008535

A phase 1 trial of fully human BCMA CAR-T therapy ... No treatment-related deaths occurred. At a median follow-up of 67.3 months, treated patients had an ORR of 100%, including a stringent complete ...

7. stanfordhealthcare.org stanfordhealthcare.org/trials/a/NCT06153251.html

A Study to Assess BMS-986453 in Participants With ... A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma · Trial ID or NCT# · Status · Purpose · Official Title · Eligibility ...

8. bmsstudyconnect.com bmsstudyconnect.com/es/en/health-studies/blood-cancer-clinical-trials/multiple-myeloma-clinical-trials.html

Multiple Myeloma Clinical Trials | BMS Study Connect Information about clinical trials for patients with multiple myeloma.