30 Participants NeededMy employer runs this trial

Teclistamab for Plasmablastic Lymphoma

Recruiting at 5 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and ideal dose of teclistamab, a new treatment for plasmablastic lymphoma, an aggressive cancer. Teclistamab is a unique antibody that attaches to both cancer and immune cells, aiding the body in fighting cancer. The trial seeks individuals whose lymphoma has returned or did not respond to other treatments. Participants should have undergone at least one prior treatment, such as chemotherapy or radiation, that was not fully effective. This trial may suit those not helped by other options and who have measurable lymphoma. As a Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects in people.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on other investigational agents or certain corticosteroids, except for specific conditions like adrenal insufficiency. It's best to discuss your current medications with the trial team.

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

Research has shown that teclistamab, the treatment being tested, is generally easy for patients to handle. In earlier studies, most participants did not experience serious side effects. Patients with other health conditions also tolerated it well, suggesting safety for a diverse group of individuals. Overall, evidence suggests that teclistamab may be a safe and manageable option for those with recurring or difficult-to-treat plasmablastic lymphoma.12345

Why do researchers think this study treatment might be promising?

Teclistamab is unique because it offers a new approach to treating plasmablastic lymphoma by targeting a specific protein called BCMA (B-cell maturation antigen) found on the surface of cancer cells. Unlike traditional chemotherapy treatments, which attack both cancerous and healthy cells, teclistamab is designed to precisely target and destroy cancer cells, potentially reducing side effects. Additionally, it is administered subcutaneously, which can be more convenient and less invasive compared to intravenous chemotherapy. Researchers are excited about teclistamab because its targeted mechanism could mean more effective treatment with fewer side effects for patients.

What evidence suggests that teclistamab might be an effective treatment for plasmablastic lymphoma?

Research has shown that teclistamab offers promising results for treating certain blood cancers. In some studies, teclistamab enabled some patients to achieve a complete response, meaning their cancer was undetectable after treatment. One study found that 63% of patients experienced a positive response, with their cancer shrinking or disappearing. Additionally, teclistamab has been associated with better survival rates, as many patients experienced longer periods without disease progression. This trial will evaluate teclistamab for treating plasmablastic lymphoma, particularly when other treatments have failed.16789

Who Is on the Research Team?

JG

James Godfrey

Principal Investigator

City of Hope Comprehensive Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for adults (18+) with plasmablastic lymphoma that has come back or not responded to previous treatment. Participants must have measurable disease, have tried at least one prior therapy, be in reasonably good physical condition, and have adequate blood counts and organ function.

Inclusion Criteria

I have had at least one previous chemotherapy or radiation treatment.
I have at least one tumor or lymph node that can be measured by scans.
My kidney function, measured by GFR, is at least 30.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive teclistamab subcutaneously on days 1, 4, and 7 in Cycle 1, then on day 1 of subsequent cycles, with cycles repeating weekly, every 2 weeks, or every 4 weeks based on dose level

Up to 13 cycles
Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Every 3 months for up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Teclistamab

Trial Overview

The study is testing teclistamab, a new antibody drug, to find the safest dose and check its side effects in people with recurrent or hard-to-treat plasmablastic lymphoma. Imaging scans and lab tests will also be used to monitor patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment (teclistamab)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

Targeting BCMA in Plasmablastic Lymphoma With Teclistamab

A complete response was observed in 2 patients: 1 patient remains in remission after 2 years of teclistamab treatment, while the second achieved a complete ...

Real-World Long-Term Effectiveness and Safety Outcomes ...

teclistamab demonstrated an 18-month overall survival (OS) rate of 60%. teclistamab demonstrated an ORR of 63%, a median duration of response (DOR) of 24.0 ...

Real-world Data Shows Teclistamab Can Benefit Many ...

The bispecific antibody reduced disease burden by at least half in 53% (270) of the 506 evaluable patients, with 45% (228) having at least 90% ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41771248/

Targeting BCMA in Plasmablastic Lymphoma With Teclistamab

A complete response was observed in 2 patients: 1 patient remains in remission after 2 years of teclistamab treatment, while the second achieved ...

Teclistamab Significantly Improves Survival Among ...

teclistamab monotherapy significantly improved progression-free survival (PFS) and overall survival (OS) of 3.8 to 4.6 months. 79.2% versus 68. ...

NCT07332507 | Testing the Effect of Teclistamab on ...

Giving teclistamab may be safe and tolerable in treating patients with recurrent or refractory plasmablastic lymphoma.

Targeting BCMA in Plasmablastic Lymphoma: Two Cases ...

In our cases, teclistamab was a well tolerated therapy, even in our patient with significant comorbidities. This report provides a foundation ...

Real-World Analysis Shows Similar Safety, Efficacy With ...

the overall response rate (ORR) was 66%, compared with 63% in 64% of patients,

Safety and Efficacy of Teclistamab in Patients with ...

teclistamab was safe and effective. Extramedullary disease and poor performance status were associated with inferior best overall response rate and progression ...