Relapsed/ Refractory Multiple MyelomaPhase 1TRIMM-3NCT05338775
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 1 study testing Talquetamab, Teclistamab and PD-1 Inhibitor in people with Relapsed/ Refractory Multiple Myeloma, run by Janssen Research & Development, LLC at 19 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/ Refractory Multiple Myeloma
- What is being tested?
- Talquetamab, Teclistamab and PD-1 Inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 25 May 2022to 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
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
United States7 sites
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
The Blavatnik Family Chelsea Medical Center at Mount Sinai
New York, New York, 10011
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
France4 sites
CHU de Montpellier Hopital Saint Eloi
Montpellier, 34295
CHU de Nantes hotel Dieu
Nantes, 44093
CHU Poitiers - Hopital la Miletrie
Poitiers, 86021
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059
Germany4 sites
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Universitaetsklinikum Hamburg Eppendorf
Hamburg, 20246
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Universitatsklinikum Wurzburg
Würzburg, 97080
Spain4 sites
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Hosp Univ Fund Jimenez Diaz
Madrid, 28040
Clinica Univ. de Navarra
Pamplona, 31008
Hosp Clinico Univ de Salamanca
Salamanca, 37007
About this study
Official 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
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
- Being tested
- Talquetamab, Teclistamab, PD-1 Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalquetamabDrug
Talquetamab will be administered as a subcutaneous (SC) injection.
TeclistamabDrug
Teclistamab will be administered as a SC injection.
PD-1 InhibitorDrug
The PD-1 inhibitor will be administered as an intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly. Receives: 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. Receives: Drug: Talquetamab; Drug: Teclistamab; Drug: PD-1 Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years 5 months
Secondary outcomes (12)
Overall Response Rate (ORR)
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.
Measured: Up to 2 years 5 months
Very Good Partial Response (VGPR) or Better Response Rate
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.
Measured: Up to 2 years 5 months
Complete Response (CR) or Better Response Rate
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.
Measured: Up to 2 years 5 months
Stringent Complete Response (sCR) Rate
sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria.
Measured: Up to 2 years 5 months
Duration of Response
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.
Measured: Up to 2 years 5 months
Time to Response
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.
Measured: Up to 2 years 5 months
Serum Concentrations of Talquetamab
Serum samples will be analyzed to determine concentrations of Talquetamab using validated, specific, and sensitive immunoassay methods.
Measured: Up to 2 years 5 months
Serum Concentrations of Teclistamab
Serum samples will be analyzed to determine concentrations of Teclistamab using validated, specific, and sensitive immunoassay methods.
Measured: Up to 2 years 5 months
Serum Concentrations of PD-1 Inhibitor
Serum samples will be analyzed to determine concentrations of PD-1 inhibitor using validated, specific, and sensitive immunoassay methods.
Measured: Up to 2 years 5 months
Number of Participants with Anti-Talquetamab Antibodies
Number of participants with anti-talquetamab antibodies will be reported.
Measured: Up to 2 years 5 months
Number of Participants with Anti-Teclistamab Antibodies
Number of participants with anti-teclistamab antibodies will be reported.
Measured: Up to 2 years 5 months
Number of Participants with Anti-PD-1 Inhibitor Antibodies
Number of participants with anti-PD-1 inhibitor antibodies will be reported.
Measured: Up to 2 years 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start25 May 2022
- Primary completion22 May 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/ Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research and Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338775
- Sponsor's protocol ID
- CR109168
- Other IDs
- 64407564MMY1005, 2021-005073-22, 2022-502681-24-00
- Acronym
- TRIMM-3
- Status last verified
- Nov 2026
- First submitted
- 31 Mar 2022
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05338775
- Acronym / sponsor ID
- TRIMM-3 / CR109168
- Conditions
- Relapsed/ Refractory Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: Talquetamab, Drug: Teclistamab, Drug: PD-1 InhibitorParticipants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly. |
| Part 2: Dose Expansion | Experimental | Drug: Talquetamab, Drug: Teclistamab, Drug: PD-1 InhibitorParticipants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalquetamabTalquetamab will be administered as a subcutaneous (SC) injection. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| TeclistamabTeclistamab will be administered as a SC injection. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
| PD-1 InhibitorThe PD-1 inhibitor will be administered as an intravenous injection. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to 2 years 5 months
Very Good Partial Response (VGPR) or Better Response Rate
Time frame: Up to 2 years 5 months
Complete Response (CR) or Better Response Rate
Time frame: Up to 2 years 5 months
Stringent Complete Response (sCR) Rate
Time frame: Up to 2 years 5 months
Duration of Response
Time frame: Up to 2 years 5 months
Time to Response
Time frame: Up to 2 years 5 months
Serum Concentrations of Talquetamab
Time frame: Up to 2 years 5 months
Serum Concentrations of Teclistamab
Time frame: Up to 2 years 5 months
Serum Concentrations of PD-1 Inhibitor
Time frame: Up to 2 years 5 months
Number of Participants with Anti-Talquetamab Antibodies
Time frame: Up to 2 years 5 months
Number of Participants with Anti-Teclistamab Antibodies
Time frame: Up to 2 years 5 months
Number of Participants with Anti-PD-1 Inhibitor Antibodies
Time frame: Up to 2 years 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research and Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talquetamab, Teclistamab and PD-1 Inhibitor in people with Relapsed/ Refractory Multiple Myeloma, run by Janssen Research & Development, LLC at 19 sites in 4 countries.
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, France, Germany, Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to 2 years 5 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.