Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

NCT07332507 | Not Yet Recruiting Phase 1 FDA Drug

• 4 other identifiers: NCI-2025-09714PHI-15510727UM1CA186717
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase Ib trial tests the safety, side effects, and best dose, as well as the effectiveness 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, tolerable, and/or more effective than usual treatment with radiation or chemotherapy in treating patients with recurrent or refractory plasmablastic lymphoma.

Conditions

Refractory Plasmablastic Lymphoma; Recurrent Plasmablastic Lymphoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. and American Society for Transplantation and Cellular Therapy/Immune Effector Cell Associated Neurotoxicity Syndrome criteria/grading. Descriptive statistics will be employed in the analysis of all safety observations in this study.

  Up to 28 days after last dose of study treatment

Secondary Outcomes (4)

• Overall response rate (ORR)

  Up to 2 years after last dose of study treatment

• Complete response rate

  Up to 2 years after last dose of study treatment

• Progression-free survival (PFS)

  From start of protocol treatment to time of progressive disease/relapse or death due to any cause, whichever occurs earlier, assessed up to 2 years

• Overall survival (OS)

  From start of protocol treatment to time of death due to any cause, assessed up to 2 years

Other Outcomes (2)

• Utility of B-cell maturation antigen (BCMA) as a biomarker of response

  Up to 2 years after last dose of study treatment

• Impact of minimum residual disease (MRD) on PFS

  Up to 2 years after last dose of study treatment

Study Arms (1)

Treatment (teclistamab)

EXPERIMENTAL

Patients receive teclistamab SC on days 1, 4, and 7 of cycle 1 and 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.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Drug: Teclistamab

Interventions

Biospecimen Collection PROCEDURE

Undergo buccal swab and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Treatment (teclistamab)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (teclistamab)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Treatment (teclistamab)

Teclistamab DRUG

Given SC

Also known as: JNJ 64007957, JNJ-64007957, JNJ64007957, Teclistamab-cqyv, Tecvayli

Treatment (teclistamab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed R/R PBL
• Patients must have measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as ≥ 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as ≥ 1.0 cm in its longest dimension
• Patients should have ≥ 1 line of prior therapy. This includes at least 1 prior line of chemotherapy or radiation
• Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of teclistamab in patients \< 18 years of age, children are excluded from this study
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
• Absolute neutrophil count ≥ 1,000/mcL
• Platelets ≥ 75,000/mcL
• Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
• Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m\^2
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
• Patients with central nervous system (CNS) lymphoma are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

You may not qualify if:

• Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia and peripheral neuropathy
• Patients who are receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to teclistamab
• Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
• Pregnant women are excluded from this study because teclistamab is a bispecific T-cell antibody agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with teclistamab, breastfeeding should be discontinued if the mother is treated with teclistamab. These potential risks may also apply to other agents used in this study
• Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation
• Corticosteroid use for purposes other than lymphoma symptom control
• The use of inhaled corticosteroids is permitted
• The use of mineralocorticoids for management of orthostatic hypotension is permitted
• The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted
• Participants who require lymphoma symptom control during screening may receive steroids in the following manner:
• Up to 100 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

MeSH Terms

Conditions

Plasmablastic Lymphoma

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• James Godfrey

  City of Hope Comprehensive Cancer Center LAO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 12, 2026
• Study Start: May 29, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share