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

NCT05338775 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: CR10916864407564MMY10052021-005073-222022-502681-24-00
• Study Type: interventional
• Target: 74
• Locations: 4 countries
• Sites: 19

Brief Summary

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.

Conditions

Relapsed/ Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  Up to 2 years 5 months

• Number of Participants with Adverse Events (AEs) by Severity

  An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.

  Up to 2 years 5 months

• Number of Participants with Abnormalities in Clinical Laboratory Assessments

  Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported.

  Up to 2 years 5 months

• Number of Participants with Dose-Limiting Toxicity (DLTs)

  The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

  Up to 2 years 5 months

Secondary Outcomes (12)

• Overall Response Rate (ORR)

  Up to 2 years 5 months

• Very Good Partial Response (VGPR) or Better Response Rate

  Up to 2 years 5 months

• Complete Response (CR) or Better Response Rate

  Up to 2 years 5 months

• Stringent Complete Response (sCR) Rate

  Up to 2 years 5 months

• Duration of Response

  Up to 2 years 5 months

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.

Drug: Talquetamab; Drug: Teclistamab; Drug: PD-1 Inhibitor

Part 2: Dose Expansion

EXPERIMENTAL

Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.

Drug: Talquetamab; Drug: Teclistamab; Drug: PD-1 Inhibitor

Interventions

Talquetamab DRUG

Talquetamab will be administered as a subcutaneous (SC) injection.

Part 1: Dose Escalation; Part 2: Dose Expansion

Teclistamab DRUG

Teclistamab will be administered as a SC injection.

Part 1: Dose Escalation; Part 2: Dose Expansion

PD-1 Inhibitor DRUG

The PD-1 inhibitor will be administered as an intravenous injection.

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (19)

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

The Blavatnik Family Chelsea Medical Center at Mount Sinai

New York, New York, 10011, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

CHU de Montpellier Hopital Saint Eloi

Montpellier, 34295, France

Location

CHU de Nantes hotel Dieu

Nantes, 44093, France

Location

CHU Poitiers - Hopital la Miletrie

Poitiers, 86021, France

Location

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31059, France

Location

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Interventions

talquetamab; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Janssen Research and Development, LLC Clinical Trial

  Janssen Research and Development LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 21, 2022
• Study Start: May 25, 2022
• Primary Completion: May 22, 2025
• Study Completion (Estimated): May 3, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7); DE (4); FR (4); ES (4)