Teclistamab for Waldenström's Macroglobulinemia

Not yet recruiting at 1 trial location
AB
Overseen ByAndrew Branangan, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts General Hospital
Must be taking: BTK inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called teclistamab for individuals with Waldenström's macroglobulinemia, a type of blood cancer. Researchers aim to determine if teclistamab effectively kills cancer cells and if it remains safe and tolerable for patients who have previously tried other treatments. The trial seeks participants whose Waldenström's macroglobulinemia has returned or not responded to prior treatments, such as specific antibodies or inhibitors. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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

Research has shown that teclistamab is generally well-tolerated by patients. In earlier studies, some patients experienced side effects, but most were mild. For instance, cytokine release syndrome (CRS), a strong immune reaction, occurred in 71.1% of patients. However, all cases were mild and not serious.

Teclistamab is also undergoing tests in other studies for conditions like Waldenström's macroglobulinemia, indicating its perceived safety. The lack of severe side effects in these studies is encouraging for prospective clinical trial participants.12345

Why do researchers think this study treatment might be promising for Waldenstrom's macroglobulinemia?

Teclistamab is unique because it introduces a novel approach to treating Waldenström's Macroglobulinemia by engaging the body's immune system differently. Unlike standard treatments like rituximab or ibrutinib, which mainly target certain proteins on cancer cells, teclistamab is a bispecific antibody that specifically targets CD3 on T-cells and BCMA on cancer cells, effectively directing the immune system to attack the cancer. Researchers are excited about teclistamab because its targeted mechanism could lead to more effective and potentially longer-lasting responses with manageable side effects compared to existing therapies.

What evidence suggests that teclistamab might be an effective treatment for Waldenstrom's macroglobulinemia?

Research has shown that teclistamab yields promising results for treating multiple myeloma and Waldenström's macroglobulinemia. In earlier studies, 58% of patients who received teclistamab experienced a very good partial response or better, indicating significant cancer reduction. Additionally, 29% of patients achieved a complete response, with no detectable signs of cancer. This suggests that teclistamab effectively targets and destroys cancer cells by focusing on BCMA, a protein found on these cells. These findings offer hope that teclistamab could serve as an effective treatment option for people with Waldenström's macroglobulinemia. Participants in this trial will receive teclistamab to further evaluate its effectiveness for this condition.678910

Who Is on the Research Team?

AB

Andrew Branagan, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for people with Waldenström's macroglobulinemia whose disease has come back or not responded after previous treatments. Participants must be able to safely receive the study drug and follow the treatment plan.

Inclusion Criteria

I have had plasmapheresis if I have symptoms of thickened blood.
Meeting criteria for treatment per IWWM2 criteria
Ability to adhere to study visit schedule and protocol requirements
See 10 more

Exclusion Criteria

I do not have any serious health or mental issues that prevent me from giving informed consent.
I am currently pregnant, breastfeeding, or planning to be during the study.
I do not have serious or unstable heart problems.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive teclistamab for up to 9 cycles: cycle 1 is 14 days, cycles 2-5 are 28 days, and cycles 6-9 are 56 days, or until disease progression or unacceptable side effects occur

Up to 9 cycles
Cycle 1: 3 visits (days 1, 4, 7), subsequent cycles: weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, up to 3 years from the last treatment date

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Teclistamab

Trial Overview

The study is testing teclistamab, a medicine that targets cancer cells, in people with relapsed or hard-to-treat Waldenström's macroglobulinemia. Treatment lasts up to 9 cycles unless side effects or other issues arise. The trial will monitor effectiveness and safety.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TeclistamabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Johnson & Johnson

Industry Sponsor

Trials
116
Recruited
167,000+

Citations

How long does teclistamab provide complete response in ...

This approval, based on results from the phase 3 MajesTEC-3 clinical trial, showed significantly improved outcomes compared with standard ...

Plasma Cell Neoplasms (Including Multiple Myeloma) ...

Treatment of Waldenström Macroglobulinemia (Lymphoplasmacytic Lymphoma) ... efficacy outcomes of the phase 3 Dreamm-7 trial. [Abstract] ...

MZB1 TCR-Like CAR T-Cell Therapy Yields Antitumor ...

We were able to generate a potent disease control rate, like CAR T-cell therapy, and it worked against multiple myeloma and Waldenström ...

ASH 2021 Recap: Multiple Myeloma

58% of patients receiving teclistamab achieved a very good partial response or better · 29% achieved a complete response (CR) · 21% achieved a ...

An Antibody-Drug Conjugate Lengthens PFS in Newly ...

“Overall, the FLAIR study demonstrated that ibrutinib/rituximab has superior progression-free survival advantage over FCR in fit patients with ...

Teclistamab In Waldenstrom's Macroglobulinemia

This research study is evaluating a less frequent and shorter dosing schedule of teclistamab compared to the approved dosing schedule for ...

Waldenström macroglobulinemia: 2023 update on diagnosis ...

The 10-year survival rate is now 66%. In a population-based study of Latin American patients with WM and lymphoplasmacytic lymphoma, 5-year relative survival ...

Waldenstrom Macroglobulinemia Clinical Trials

The purpose of this study is to evaluate the safety and effectiveness of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's ...

Teclistamab In Waldenstrom's... | Clinical Trial

This study also aims to assess the safety and tolerability of teclistamab, how quickly and to what extent response is seen in participants, how ...

Paper: Real-World Characteristics, Step-up Dosing ...

We sought to examine real-world data of patients with RRMM who initiated teclistamab early (within one year of approval) vs later (after one year) to examine ...