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Active, Not Recruiting

NCT Number: NCT05338775

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Relapsed/ Refractory Multiple Myeloma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Montpellier Hopital Saint Eloi, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Talquetamab

Drug

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

Teclistamab

Drug

Teclistamab will be administered as a SC injection.

PD-1 inhibitor

Drug

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

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to 2 years 5 months

    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.

  2. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: Up to 2 years 5 months

    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.

  3. Number of Participants with Abnormalities in Clinical Laboratory Assessments

    Time frame: Up to 2 years 5 months

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

  4. Number of Participants with Dose-Limiting Toxicity (DLTs)

    Time frame: Up to 2 years 5 months

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

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 2 years 5 months

    ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria.

  2. Very Good Partial Response (VGPR) or Better Response Rate

    Time frame: Up to 2 years 5 months

    VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.

  3. Complete Response (CR) or Better Response Rate

    Time frame: Up to 2 years 5 months

    CR or better response rate is defined as the percentage of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.

  4. Stringent Complete Response (sCR) Rate

    Time frame: Up to 2 years 5 months

    sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.

  5. Duration of Response

    Time frame: Up to 2 years 5 months

    Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG 2016 criteria or death due to any cause, whichever occurs first.

  6. Time to Response

    Time frame: Up to 2 years 5 months

    Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.

  7. Serum Concentrations of Talquetamab

    Time frame: Up to 2 years 5 months

    Serum samples will be analyzed to determine concentrations of Talquetamab using validated, specific, and sensitive immunoassay methods.

  8. Serum Concentrations of Teclistamab

    Time frame: Up to 2 years 5 months

    Serum samples will be analyzed to determine concentrations of Teclistamab using validated, specific, and sensitive immunoassay methods.

  9. Serum Concentrations of PD-1 Inhibitor

    Time frame: Up to 2 years 5 months

    Serum samples will be analyzed to determine concentrations of PD-1 inhibitor using validated, specific, and sensitive immunoassay methods.

  10. Number of Participants with Anti-Talquetamab Antibodies

    Time frame: Up to 2 years 5 months

    Number of participants with anti-talquetamab antibodies will be reported.

  11. Number of Participants with Anti-Teclistamab Antibodies

    Time frame: Up to 2 years 5 months

    Number of participants with anti-teclistamab antibodies will be reported.

  12. Number of Participants with Anti-PD-1 Inhibitor Antibodies

    Time frame: Up to 2 years 5 months

    Number of participants with anti-PD-1 inhibitor antibodies will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: TRIMM-3

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Apr 21, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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