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Test af effekten af Teclistamab på tilbagevendende plasmablastisk lymfom

17. oktober 2026 opdateret af: National Cancer Institute (NCI)

Fase 1b-studie af Teclistamab ved tilbagevendende/refraktær plasmablastisk lymfom

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

I. 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:

I. 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • Rekruttering
        • City of Hope Comprehensive Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • James Godfrey
      • Irvine, California, Forenede Stater, 92612
        • Rekruttering
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Kontakt:
        • Ledende efterforsker:
          • Elizabeth A. Brem
      • Los Angeles, California, Forenede Stater, 90033
        • Rekruttering
        • USC / Norris Comprehensive Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 323-865-0451
        • Ledende efterforsker:
          • Zaw Win Myint
      • Orange, California, Forenede Stater, 92868
        • Rekruttering
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Elizabeth A. Brem
    • Florida
      • Coral Gables, Florida, Forenede Stater, 33146
        • Rekruttering
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Ledende efterforsker:
          • Asaad Trabolsi
      • Coral Springs, Florida, Forenede Stater, 33065
        • Rekruttering
        • UM Sylvester Comprehensive Cancer Center at Coral Springs
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Ledende efterforsker:
          • Asaad Trabolsi
      • Deerfield Beach, Florida, Forenede Stater, 33442
        • Rekruttering
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Ledende efterforsker:
          • Asaad Trabolsi
      • Doral, Florida, Forenede Stater, 33166
        • Rekruttering
        • UM Sylvester Comprehensive Cancer Center at Doral
        • Kontakt:
        • Ledende efterforsker:
          • Asaad Trabolsi
      • Hollywood, Florida, Forenede Stater, 33021
        • Rekruttering
        • UM Sylvester Comprehensive Cancer Center at Hollywood
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Ledende efterforsker:
          • Asaad Trabolsi
      • Miami, Florida, Forenede Stater, 33136
        • Rekruttering
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Ledende efterforsker:
          • Asaad Trabolsi
      • Miami, Florida, Forenede Stater, 33176
        • Rekruttering
        • UM Sylvester Comprehensive Cancer Center at Kendall
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Ledende efterforsker:
          • Asaad Trabolsi
      • Plantation, Florida, Forenede Stater, 33324
        • Rekruttering
        • UM Sylvester Comprehensive Cancer Center at Plantation
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 305-243-2647
        • Ledende efterforsker:
          • Asaad Trabolsi
    • Illinois
      • Shiloh, Illinois, Forenede Stater, 62269
        • Rekruttering
        • Memorial Hospital East
        • Kontakt:
        • Ledende efterforsker:
          • Dilan A. Patel
    • Missouri
      • City of Saint Peters, Missouri, Forenede Stater, 63376
        • Rekruttering
        • Siteman Cancer Center at Saint Peters Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Dilan A. Patel
      • Creve Coeur, Missouri, Forenede Stater, 63141
        • Rekruttering
        • Siteman Cancer Center at West County Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Dilan A. Patel
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Washington University School of Medicine
        • Kontakt:
        • Ledende efterforsker:
          • Dilan A. Patel
      • St Louis, Missouri, Forenede Stater, 63129
        • Rekruttering
        • Siteman Cancer Center-South County
        • Kontakt:
        • Ledende efterforsker:
          • Dilan A. Patel
      • St Louis, Missouri, Forenede Stater, 63136
        • Rekruttering
        • Siteman Cancer Center at Christian Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Dilan A. Patel
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • Ohio State University Comprehensive Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Kathryn Lurain
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • Rekruttering
        • UPMC Hillman Cancer Center
        • Ledende efterforsker:
          • Kathleen A. Dorritie
        • Kontakt:
          • Site Public Contact
          • Telefonnummer: 412-647-8073

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Positron Emission Tomography

Undergo PET/CT

Andre navne:
  • Medicinsk billeddannelse, Positron Emission Tomografi
  • KÆLEDYR
  • PET-scanning
  • Positron Emission Tomografi Scan
  • Positron-emissionstomografi
  • PT
  • Positron emissionstomografi (procedure)
Procedure: Computed Tomography

Undergo PET/CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Medicin: Teclistamab

Given SC

Andre navne:
  • JNJ-64007957
  • Tecvayli
  • JNJ 64007957
  • JNJ64007957
  • Teclistamab-cqyv
Procedure: Biospecimen Collection

Undergo buccal swab and blood sample collection

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of adverse events
Tidsramme: Up 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.
Up to 28 days after last dose of study treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall response rate (ORR)
Tidsramme: Up to 2 years after last dose of study treatment

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.
Up to 2 years after last dose of study treatment
Complete response rate
Tidsramme: Up to 2 years after last dose of study treatment

Will be assessed by the 2014 Lugano Response Criteria (Cheson et al., 2014).
Up to 2 years after last dose of study treatment
Progression-free survival (PFS)
Tidsramme: 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

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

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Utility of B-cell maturation antigen (BCMA) as a biomarker of response
Tidsramme: Up to 2 years after last dose of study treatment

Archival pre-treatment formalin fixed and paraffin embedded tumor samples will be stained with a BCMA immunohistochemistry (IHC) antibody (clone E6D7B) and an H-score will be determined by an expert hematopathologist. Associations between BCMA IHC H-score and response to teclistamab will be determined using a Fisher's exact test at an H-score cutoff of 100.
Up to 2 years after last dose of study treatment
Impact of minimum residual disease (MRD) on PFS
Tidsramme: Up to 2 years after last dose of study treatment

Impact will be determined by a cycle 3 circulating tumor deoxyribonucleic acid level on 2-year PFS. The Kaplan-Meier method will be used to estimate PFS and a log-rank test will be used to compare the PFS between MRD-positive and MRD-negative groups.
Up to 2 years after last dose of study treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: James Godfrey, City of Hope Comprehensive Cancer Center LAO

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

26. marts 2027

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

9. januar 2026

Først indsendt, der opfyldte QC-kriterier

9. januar 2026

Først opslået (Faktiske)

12. januar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. oktober 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2025-09714
  • UM1CA186717 (U.S. NIH-bevilling/kontrakt)
  • NCI-2025-09714 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • PHI-155
  • 10727 (Anden identifikator: CTEP)
  • 10727 (Anden identifikator: City of Hope Comprehensive Cancer Center LAO)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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