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NCT05338775Active, not recruitingPhase 1

A Study of Talquetamab and Teclistamab Each in Combination With a Programmed Cell Death Receptor-1 (PD-1) Inhibitor for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination With Checkpoint Inhibition for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
74 (actual)
First submitted
31 Mar 2022
Start date
25 May 2022
Primary completion date
22 May 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05338775
EU CT number
2022-502681-24-00
EudraCT number
2021-005073-22

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 74
  • From 25 May 2022 to the primary completion date, 22 May 2025
  • 16 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor \[PI\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months)
  • Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant
  • Live, attenuated vaccine within 4 weeks before the first dose of study treatment
  • Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\<=) 1 (except alopecia \[any grade\] or peripheral neuropathy to Grade \<= 2)
  • Received a cumulative dose of corticosteroids equivalent to \>= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration

Other illness

  • Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis

Other

  • Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required

Who the study is looking for

  • Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit
  • Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level \>= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Technische Universitaet Dresden
Coordinator of this site? Confirm its status
DresdenGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
Coordinator of this site? Confirm its status
WuerzburgGermanyActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
Coordinator of this site? Confirm its status
Montpellier Cedex 5FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceActive, not recruiting
Institut Universitaire du Cancer Toulouse - Oncopole
Coordinator of this site? Confirm its status
ToulouseFranceActive, not recruiting
Colorado Blood Cancer Institute
Coordinator of this site? Confirm its status
DenverUnited StatesUnknown status
Vanderbilt-Ingram Cancer Center
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Sarah Cannon Research Institute
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NashvilleUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
The Blavatnik Family ? Chelsea Medical Center at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Wake Forest Baptist Medical Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.