Teclistamab for recurrent or refractory plasmablastic lymphoma
Official title: Phase 1b Study of Teclistamab in Relapsed/Refractory Plasmablastic Lymphoma
Run by National Cancer Institute (NCI) · NCT07332507 · Data updated 2026-11-12
This early-phase trial tests a bispecific antibody called teclistamab to see if it is safe and usable at different doses for adults whose plasmablastic lymphoma has returned or not responded to previous treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | National Cancer Institute (NCI) NIH |
| Drugs / interventions | teclistamab, CAR-T, chemotherapy, radiation, prednisone |
| Locations | 20 sites (Duarte, California and 19 other locations) |
| Status | Recruiting |
| Started | March 26, 2027 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07332507 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed relapsed or refractory plasmablastic lymphoma, measurable disease, at least one prior therapy, ECOG 0-2, and adequate organ function.
✕Probably not a fit
Patients with progressive disease, severe toxicity, or lack of response to teclistamab may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase Ib study investigates the safety, tolerability, and best dose (RP2D) of teclistamab, a BCMA-CD3 bispecific antibody, in adults with relapsed or refractory plasmablastic lymphoma. Participants receive subcutaneous teclistamab on a defined schedule across cycles, with dose-level dependent intervals, and may continue beyond cycle 13 if benefiting. Secondary aims include estimating overall response rates, progression-free and overall survival, and documenting anti-tumor activity; exploratory aims look at BCMA as a biomarker and MRD dynamics. The trial collects imaging, biospecimens, and optional buccal swabs, at multiple time points, to correlate outcomes with biological markers.
Why it matters
Potential benefit: If successful, participants may experience tumor shrinkage or prolonged disease control with teclistamab.
How similar studies have gone: Early studies in other BCMA-targeted or bispecific therapies have shown activity in hematologic cancers, supporting exploration in plasmablastic lymphoma.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Where it's running
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City of Hope Comprehensive Cancer Center
Duarte, California, United States Recruiting -
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States Recruiting -
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States Recruiting -
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Coral Springs
Coral Springs, Florida, United States Recruiting
Show 14 more locations
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UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Hollywood
Hollywood, Florida, United States Recruiting -
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, United States Recruiting -
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, United States Recruiting -
Memorial Hospital East
Shiloh, Illinois, United States Recruiting -
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States Recruiting -
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States Recruiting -
Washington University School of Medicine
St Louis, Missouri, United States Recruiting -
Siteman Cancer Center-South County
St Louis, Missouri, United States Recruiting -
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States Recruiting -
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States Recruiting -
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: James Godfrey — City of Hope Comprehensive Cancer Center LAO
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.