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Teclistamab for Recurrent or Refractory Plasmablastic Lymphoma

This study is testing a drug called teclistamab for people with plasmablastic lymphoma that has come back (recurrent) or hasn't responded to previous treatments (refractory). Teclistamab is a bispecific antibody, meaning it can attach to two different targets at once. It aims to interfere with the growth and spread of cancer cells. Researchers want to find the safest and most effective dose, and see how well it works. You might be able to join if you are 18 or older, have confirmed recurrent or refractory plasmablastic lymphoma, and have measurable disease. The study is looking at side effects and how many people respond to the treatment.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is a Phase Ib trial, meaning it's an early study to test safety and dosage.
What's involved
You would receive teclistamab injections under the skin, initially three times in the first week, then weekly, every two weeks, or every four weeks, depending on the dose level. You will also have buccal swabs, blood draws, and PET/CT scans.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 28 days after your last dose of teclistamab.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07332507

Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
National Cancer Institute (NCI)
~30 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyPositron Emission TomographyTeclistamab

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 28 days after last dose of study treatment

Conditions

Recurrent Plasmablastic Lymphoma
Refractory Plasmablastic Lymphoma

Explore related trials

Plasmablastic LymphomaCD3 Complex

NCT07332507

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope Comprehensive Cancer Center

    Duarte, Californiastudy coordinator listed

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, Californiastudy coordinator listed

    Recruiting

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, Californiastudy coordinator listed

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • James Godfrey · PRINCIPAL_INVESTIGATOR · City of Hope Comprehensive Cancer Center LAO

Who to contact

Site Public Contact
[email protected]
800-826-4673
Email the study team

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Eligibility criteria

Inclusion

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%)
Hemoglobin ≥ 8 g/dL, transfusion permitted if ≥ 7 days
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 they have no CNS-related symptoms at study entry, and 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 should either have received an autologous transplant or not be a candidate for one
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
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
Based on the mechanism of action, teclistamab may cause fetal harm when administered to a pregnant woman. Females of child-bearing potential (FCBP) should use effective contraception during treatment with teclistamab and for 6 months after the last dose. FCBP should not breast feed during treatment with teclistamab and for 6 months after the last dose. Should a FCBP become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Male patients with a partner who is a FCBP should use effective contraception during treatment and for 3 months after the last dose of teclistamab. Women of childbearing age should not donate eggs and men should not donate sperm for the duration of study participation. Women should not donate eggs for 6 months and men should not donate sperm for 3 months after completion of the last dose of study drug
Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Vaccination with live virus vaccines is not recommended for at least 4 weeks prior to the start of treatment, during treatment and at least 4 weeks after treatment

Exclusion

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
Prior treatment with B-cell maturation antigen (BCMA)-targeted therapies
Prior treatment with T-cell engager therapies (bispecific, CAR-T, etc.) within the last 6 months

What this trial measures

  • Incidence of adverse eventsUp to 28 days after last dose of study treatment

    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.