Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma
Part of paid clinical trials in Duarte, California.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT07332507
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Recurrent Plasmablastic Lymphoma
- Refractory Plasmablastic Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo buccal swab and blood sample collection
- Computed Tomography — PROCEDUREUndergo PET/CT
- Positron Emission Tomography — PROCEDUREUndergo PET/CT
- Teclistamab — DRUGGiven SC
Study Details
This phase Ib trial tests the safety, side effects, and best dose of teclistamab in treating patients with plasmablastic lymphoma that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving teclistamab may be safe and tolerable in treating patients with recurrent or refractory plasmablastic lymphoma.
Key Dates
- First listed
- Jan 12, 2026
- Start date
- Mar 26, 2027
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (teclistamab)Patients receive teclistamab SC on days 1, 4, and 7 in the absence of disease progression or unacceptable toxicity (i.e., Cycle 1). Beginning 1 week later, patients receive teclistamab SC on day 1 (i.e., Cycle 2). Beginning 1 week later, 2 weeks later, or 4 weeks later (based on dose level), patients receive teclistamab SC on day 1 of remaining cycles. Based on dose level, cycles repeat weekly, every 2 weeks, or every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who have achieved a CR by cycle 13 may discontinue study treatment. Patients achieving less than a CR but benefiting from treatment may continue to receive teclistamab beyond 13 cycles in the absence of disease progression, unacceptable toxicity, or achieving a CR. Additionally, patients undergo optional buccal swab collection at baseline and optional blood sample collection throughout the study. Patients also undergo PET/CT throughout the study.
Primary Outcome Measure
Incidence of adverse events [ Time Frame: Up to 28 days after last dose of study treatment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center LAO | Duarte | California | 91010 | James Godfrey (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Duarte, CA
Related Studies
- Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related CancersRecruiting · AIDS Malignancy Consortium · La Jolla, California