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Recurrent Plasmablastic LymphomaPhase 1NCT07332507

Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Positron Emission Tomography in people with Recurrent Plasmablastic Lymphoma and Refractory Plasmablastic Lymphoma, run by National Cancer Institute (NCI) at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Positron Emission Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
20 sitesUnited States
Study dates
26 Mar 2027to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

20 sites in 1 country

United States20 sites, 20 recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Dilan A. Patel

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Kathryn Lurain

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Asaad Trabolsi

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Springs

    Coral Springs, Florida, 33065

    Site Public Contact, 305-243-2647

    Asaad Trabolsi

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Dilan A. Patel

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Asaad Trabolsi

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Site Public Contact, kginnity@med.miami.edu

    Asaad Trabolsi

    Recruiting

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

    Site Public Contact, 800-826-4673, becomingapatient@coh.org

    James Godfrey

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Hollywood

    Hollywood, Florida, 33021

    Site Public Contact, 305-243-2647

    Asaad Trabolsi

    Recruiting

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

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Elizabeth A. Brem

    Recruiting

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Site Public Contact, 323-865-0451

    Zaw Win Myint

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Asaad Trabolsi

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

    Site Public Contact, 305-243-2647

    Asaad Trabolsi

    Recruiting

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Elizabeth A. Brem

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Kathleen A. Dorritie

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Asaad Trabolsi

    Recruiting

  • Memorial Hospital East

    Shiloh, Illinois, 62269

    Site Public Contact, 314-747-9912, dschwab@wustl.edu

    Dilan A. Patel

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Dilan A. Patel

    Recruiting

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Dilan A. Patel

    Recruiting

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Dilan A. Patel

    Recruiting

Other trials in United States

About this study

Official title: Phase 1b Study of Teclistamab in Relapsed/Refractory Plasmablastic Lymphoma

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the recommended phase 2 dose (RP2D) of teclistamab in relapsed/refractory (R/R) plasmablastic lymphoma (PBL).

SECONDARY OBJECTIVES:

  1. To estimate the overall response rate (ORR), complete response (CR) rate, progression-free survival (PFS), and overall survival (OS) of teclistamab in R/R PBL.

II. To observe and record anti-tumor activity.

EXPLORATORY OBJECTIVES:

  1. To evaluate the utility of B-cell maturation antigen (BCMA) as a biomarker of response to teclistamab in PBL.

II. To evaluate minimum residual disease (MRD) dynamics during treatment.

OUTLINE:

Patients receive teclistamab subcutaneously (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 complete response (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 positron emission tomography (PET)/computed tomography (CT) throughout the study.

After completion of study treatment, patients are followed every 3 months for up to 2 years.

Being tested
Biospecimen Collection, Computed Tomography, Positron Emission Tomography, Teclistamab
Medical subject headings
Plasmablastic Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo buccal swab and blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo PET/CT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

  • TeclistamabDrug

    Also called JNJ 64007957, JNJ-64007957, JNJ64007957, Teclistamab-cqyv

    Given SC

Study groups in NCT07332507
Study groupRoleWhat they receive
Treatment (teclistamab)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Drug: Teclistamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 28 days after last dose of study treatment

Secondary outcomes (4)

  1. Overall response rate (ORR)

    Will be assessed by the 2014 Lugano Response Criteria (Cheson et al., 2014). An alternative hypothesis of 40% ORR versus a null hypothesis of 10% will be tested in the dose-expansion cohort. A Simon's Two-Stage Minimax design (Simon, 1989) will be applied to test the hypothesis.

    Measured: Up to 2 years after last dose of study treatment

  2. Complete response rate

    Will be assessed by the 2014 Lugano Response Criteria (Cheson et al., 2014).

    Measured: Up to 2 years after last dose of study treatment

  3. Progression-free survival (PFS)

    PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. 95% confidence intervals will be constructed based on log-log transformation.

    Measured: 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

  4. Overall survival (OS)

    OS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. 95% confidence intervals will be constructed based on log-log transformation.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start26 Mar 2027 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07332507
Sponsor's protocol ID
NCI-2025-09714
Other IDs
NCI-2025-09714, PHI-155, 10727, 10727, UM1CA186717
Status last verified
Aug 2026
First submitted
9 Jan 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Positron Emission Tomography in people with Recurrent Plasmablastic Lymphoma and Refractory Plasmablastic Lymphoma, run by National Cancer Institute (NCI) at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 28 days after last dose of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07332507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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