Teclistamab for Multiple Myeloma

Recruiting at 15 trial locations

Overseen By Sarah Cannon Development Innovations, LLC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SCRI Development Innovations, LLC

Must be taking: HAART

Must not be taking: Live vaccines

Disqualifiers: High tumor burden, Rapidly progressing disease, Plasma cell leukemia, Active CNS involvement, Active infection, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months for Teclistamab or 6 months for Talquetamab

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing Teclistamab, a drug that helps the immune system fight a type of blood cancer in adults who haven't responded to other treatments. It works by connecting immune cells to cancer cells, making it easier for the body to attack the cancer. Teclistamab shows promise in multiple myeloma treatment.

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

The trial information does not specify if you need to stop taking your current medications. However, certain treatments like monoclonal antibody therapy, cytotoxic therapy, and PI therapy must be stopped for a specific period before starting the trial. It's best to discuss your current medications with the trial team.

Is teclistamab safe for humans?

Teclistamab has been shown to be generally safe in humans, but it can cause side effects like cytokine release syndrome (a condition where the immune system releases too many proteins into the blood too quickly), infections, and neurotoxicity (damage to the nervous system). These side effects require careful management by healthcare providers. ^{1 2 3 4 5}

What makes the drug Teclistamab unique for treating multiple myeloma?

Teclistamab is unique because it is a bispecific antibody that engages T-cells to target and attack multiple myeloma cells by binding to CD3 on T-cells and BCMA on myeloma cells. This mechanism offers a new approach for patients who have relapsed after multiple other treatments, with a promising response rate and a potentially more tolerable side effect profile for elderly patients. ^{2 4 5 6 7}

What data supports the effectiveness of the drug teclistamab for multiple myeloma?

Teclistamab has shown effectiveness in treating multiple myeloma, with a pivotal trial demonstrating an overall response rate of more than 60% in patients who had already tried several other treatments. It is approved by the FDA and EMA for patients with relapsed or refractory multiple myeloma, indicating its potential as a promising option for those who have not responded to other therapies. ^{2 3 4 5 6}

Who Is on the Research Team?

Robert Rifkin, MD

Principal Investigator

SCRI Development Innovations, LLC

Are You a Good Fit for This Trial?

Adults over 18 with Multiple Myeloma who've had at least four prior treatments, including specific therapies (PI, IMiD, CD38 antibody), can join. They must be in good health otherwise, not pregnant or planning to become so, and agree to use contraception. Participants need a body weight over 35 kg and must stay close to the trial site for monitoring after initial doses.

Inclusion Criteria

My organs are functioning well.

I have been diagnosed with multiple myeloma.

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

Exclusion Criteria

I do not have a fever or any active infections.

I have not received any live vaccines within the last 30 days, except for the flu vaccine.

I have a bleeding disorder that gets worse when my blood cell counts are low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive step-up dosing of Teclistamab or Talquetamab followed by regular dosing cycles

Up to 12 months for Teclistamab or 6 months for Talquetamab

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Teclistamab
• Tocilizumab

Trial Overview The study is testing Teclistamab given as an outpatient treatment for Multiple Myeloma patients. It's a phase II trial which means they're looking at how effective this drug is and what side effects it has when administered outside of a hospital setting.

How Is the Trial Designed?

Group I: Teclistamab Experimental Treatment 2 Interventions

Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy. Participants not responding to or progressing after prior response to treatment with teclistamab can be re-screened and enrolled into the talquetamab arm.

Group II: Talquetamab Experimental Treatment 2 Interventions

Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm.

Teclistamab is already approved in United States, European Union for the following indications:

Approved in United States as Tecvayli for:

• Relapsed or refractory multiple myeloma in adults who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Approved in European Union as Tecvayli for:

• Relapsed or refractory multiple myeloma in adults who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy

Who Is Running the Clinical Trial?

SCRI Development Innovations, LLC

Lead Sponsor

Trials

193

Recruited

13,800+

Johnson & Johnson

Industry Sponsor

Trials

116

Recruited

167,000+

Janssen Research & Development, LLC

Industry Sponsor

Trials

1,022

Recruited

6,408,000+

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Teclistamab-cqyv is a bispecific T-cell engager antibody that effectively activates the immune system to target multiple myeloma cells, showing an overall response rate of over 60% in heavily pretreated patients.

The side effect profile of teclistamab-cqyv is more tolerable compared to other BCMA-targeted therapies, making it a suitable treatment option for elderly patients with relapsed or refractory multiple myeloma, and it has received FDA approval for use as monotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. Hua, G., Scanlan, R., Straining, R., et al.[2023]

Teclistamab, a bispecific antibody targeting CD3 and BCMA, has received conditional approval in the EU and full approval in the US for treating adult patients with relapsed or refractory multiple myeloma after multiple prior therapies.

The approvals are based on its efficacy in patients who have undergone at least three to four previous treatments, including specific types of therapies, highlighting its role as a treatment option for difficult-to-treat cases of multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab: First Approval. Kang, C.[2022]

Teclistamab-cqyv is an FDA and EMA-approved bispecific antibody that effectively targets multiple myeloma (MM) by engaging T cells to attack cancer cells, showing a 60% overall response rate in heavily pretreated relapsed/refractory patients.

This treatment is specifically designed for patients who have undergone at least three prior therapies and have shown disease progression, highlighting its role in advanced stages of MM where other treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab-cqyv in multiple myeloma. Martino, EA., Bruzzese, A., Labanca, C., et al.[2023]

Teclistamab has demonstrated strong anti-myeloma activity in patients who have severe renal impairment, indicating its potential effectiveness in a challenging patient population.

The study highlights the importance of evaluating treatments like teclistamab for their efficacy in patients with specific health conditions, such as renal issues, which can complicate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab in patients with multiple myeloma and impaired renal function. Joiner, L., Bal, S., Godby, KN., et al.[2023]

In a phase 1-2 study involving 165 patients with relapsed or refractory multiple myeloma, teclistamab demonstrated a high overall response rate of 63%, with 39.4% achieving a complete response, indicating its efficacy as a treatment option for heavily pre-treated patients.

While teclistamab showed promising results, common adverse effects included cytokine release syndrome (72.1% of patients) and neutropenia (70.9%), though most toxicities were grade 1 or 2, suggesting a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab in Relapsed or Refractory Multiple Myeloma. Moreau, P., Garfall, AL., van de Donk, NWCJ., et al.[2023]

Teclistamab is the first bispecific antibody approved for treating relapsed or refractory multiple myeloma, showing impressive efficacy in heavily pretreated patients, making it a promising option in this challenging area of treatment.

While teclistamab offers significant benefits, it also has notable adverse effects such as cytokine release syndrome, infections, and neurotoxicity, requiring careful management and precautions by healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. Pan, D., Richter, J.[2023]

Teclistamab, a bispecific antibody for treating relapsed/refractory multiple myeloma, showed a positive exposure-response relationship for overall response rate (ORR) at the recommended phase II dose (RP2D) of 1.5 mg/kg subcutaneously weekly, based on data from 338 patients in the MajesTEC-1 study.

While factors like body weight and myeloma type influenced teclistamab's pharmacokinetics, they did not significantly affect its efficacy, indicating that the drug's effectiveness remains consistent across different patient profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. Miao, X., Wu, LS., Lin, SXW., et al.[2023]

Citations

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

Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Teclistamab: First Approval. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Teclistamab-cqyv in multiple myeloma. [2023]

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

Teclistamab in patients with multiple myeloma and impaired renal function. [2023]

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

Teclistamab in Relapsed or Refractory Multiple Myeloma. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. [2023]

7. France pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response with Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma: Results From MajesTEC-1. [2023]