Teclistamab for Multiple Myeloma

Recruiting at15 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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 6}

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. ^{1 2 3 5 7}

Research Team

Robert Rifkin, MD

Principal Investigator

SCRI Development Innovations, LLC

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Teclistamab (Monoclonal Antibodies)
• Tocilizumab (Monoclonal Antibodies)

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.

Participant Groups

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.

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

Who Is Running the Clinical Trial?

SCRI Development Innovations, LLC

Lead Sponsor

Trials

193

Recruited

13,800+

Robert Coleman

SCRI Development Innovations, LLC

Chief Medical Officer since 2022

MD

Dee Anna Smith

SCRI Development Innovations, LLC

Chief Executive Officer since 2022

Bachelor's degree in Accounting from Pepperdine University

Janssen Research & Development, LLC

Industry Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires

Findings from Research

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, 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]

References

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]