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Multiple MyelomaPhase 1/2RedirecTT-1NCT04586426

A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 study testing Talquetamab and Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 40 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Talquetamab and Teclistamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
40 sitesin 7 countries
Study dates
15 Dec 2020to 27 Oct 2026
Phase
Phase 1/2
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

  • Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration

Who cannot join

  • All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy
  • All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment.
  • All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.
  • All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis

Trial locations and contacts

40 sites in 7 countries.

40 sites in 7 countries

United States13 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham, Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • Atrium Health

    Charlotte, North Carolina, 28204

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Oregon Health And Science University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Washington University St. Louis School Medicine Siteman Cancer Center

    St Louis, Missouri, 63108

  • Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain8 sites

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Inst. Cat. Doncologia-H Duran I Reynals

    L'Hospitalet de Llobregat, 08908

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • UNIV. HOSP. October 12

    Madrid, 28041

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008

Other trials in Spain

Japan5 sites

  • Kanazawa University Hospital

    Kanazawa, 920-8641

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Osaka University Hospital

    Osaka, 565-0871

  • Tohoku University Hospital

    Sendai, 980 8574

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935

Other trials in Japan

South Korea5 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Canada4 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Alberta Health Services

    Edmonton, Alberta, T6G 1Z2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1X6

Other trials in Canada

Israel3 sites

  • Hadassah Medical Center

    Jerusalem, 91120

  • Sheba Medical Center

    Ramat Gan, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Australia2 sites

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Royal Perth Hospital

    Perth, 6000

Other trials in Australia

About this study

Official title: A Phase 1b/2 Dose Escalation and Expansion Study of the Combination of the Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R[s]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3).

Being tested
Talquetamab, Teclistamab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalquetamabDrug

    Also called JNJ-64407564

    Talquetamab will be administered by subcutaneous (SC) injection.

  • TeclistamabDrug

    Also called JNJ-64007957

    Teclistamab will be administered by SC injection.

Study groups in NCT04586426
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants will receive tec+tal in 28-day cycles following initial step-up doses. Upon sponsor notification, participants will enter the long-term extension (LTE) Phase or Drug-access Long-term Extension (DA-LTE) Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.
Receives: Drug: Talquetamab; Drug: Teclistamab
Part 2: Dose ExpansionExperimentalParticipants will receive treatment doses (combination of tal+tec regimen) which will be determined by the recommended Phase 2 regimen (s) (RP2R[s]) of the study treatment identified in Part 1. Upon sponsor notification, participants will enter the LTE Phase or DA-LTE Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.
Receives: Drug: Talquetamab; Drug: Teclistamab
Part 3: Phase 2ExperimentalParticipants will receive teclistamab + talquetamab combination therapy, at the RP2R selected from Part 1 and Part 2. Upon sponsor notification, participants will enter the LTE Phase or DA-LTE Phase and will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, discontinuation deemed necessary by the investigator or the sponsor, or access becomes available through another source such as but not limited to commercial availability, or a patient access program.
Receives: Drug: Talquetamab; Drug: Teclistamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants with Dose Limiting Toxicity (DLT)

    The dose limiting toxicities are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher.

    Measured: Approximately 5 years 10 months

  2. Part 1: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

    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: Approximately 5 years 10 months

  3. Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product, is medically important.

    Measured: Approximately 5 years 10 months

  4. Part 2: Number of Participants with Adverse Events and SAEs by Severity

    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: Approximately 5 years 10 months

  5. Part 3: Overall Response Rate (ORR)

    ORR is defined as the percentage of participants who have a partial response (PR) or better according Independent Review Committees (IRC).

    Measured: Approximately 5 years 10 months

Secondary outcomes (16)

  1. Parts 1, 2 and 3: Serum Concentration of Talquetamab

    Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive immunoassay method.

    Measured: Approximately 5 years 10 months

  2. Parts 1, 2 and 3: Serum Concentration of Teclistamab

    Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive immunoassay method.

    Measured: Approximately 5 years 10 months

  3. Part 1 and Part 2: Serum Concentration of Daratumumab

    Serum samples will be analyzed to determine concentrations of daratumumab using a validated, specific, and sensitive immunoassay method.

    Measured: Approximately 5 years 10 months

  4. Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Talquetamab

    Number of participants with anti-drug antibodies to talquetamab will be assessed.

    Measured: Approximately 5 years 10 months

  5. Parts 1, 2 and 3: Number of Participants with Anti-Drug Antibodies to Teclistamab

    Number of participants with anti-drug antibodies to teclistamab will be assessed.

    Measured: Approximately 5 years 10 months

  6. Part 1 and Part 2: Number of Participants with Anti-Drug Antibodies to Daratumumab

    Number of participants with anti-drug antibodies to daratumumab will be assessed.

    Measured: Approximately 5 years 10 months

  7. Part 1 and Part 2: Overall Response Rate (ORR)

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

    Measured: Approximately 5 years 10 months

  8. Parts 1, 2 and 3: Very Good Partial Response (VGPR) or Better Response Rate

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

    Measured: Approximately 5 years 10 months

  9. Parts 1, 2 and 3: Complete Response (CR) or Better Response Rate

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

    Measured: Approximately 5 years 10 months

  10. Part 1, 2 and 3: Stringent Complete Response (sCR) Rate

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

    Measured: Approximately 5 years 10 months

  11. Parts 1, 2 and 3: Duration of Response (DOR)

    DOR will be calculated among responders (with PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.

    Measured: Approximately 5 years 10 months

  12. Parts 1, 2 and 3: Time to Response

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

    Measured: Approximately 5 years 10 months

  13. Part 3: Progression free Survival (PFS)

    PFS is defined as the time from the date of first dose to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.

    Measured: Approximately 5 years 10 months

  14. Part 3: Overall Survival (OS)

    OS is measured from the date of first dose to the date of the participant's death.

    Measured: Approximately 5 years 10 months

  15. Part 3: Number of Participants with Adverse Events

    An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.

    Measured: Approximately 5 years 10 months

  16. Part 3: Number of Participants with Adverse Events by Severity

    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: Approximately 5 years 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start15 Dec 2020
  3. Primary completion18 Mar 2025
  4. Study completion27 Oct 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
228 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586426
Sponsor's protocol ID
CR108901
Other IDs
64007957MMY1003, 2019-004124-38, 2023-503439-16-00, 2023, 2019
Acronym
RedirecTT-1
Status last verified
Jan 2026
First submitted
12 Oct 2020
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.

Publications

  • Kumar S, Mateos MV, Ye JC, Atrash S, Magen H, Quach H, Chu MP, Trudel S, Richter J, Rodriguez-Otero P, Chuah H, Gatt M, Medvedova E, Raza S, Yoon DH, Ishida T, Matous JV, Rosinol L, Onodera K, Scott E, Heuck C, Zhang J, Henninger T, O'Rourke L, Thakkar P, Festa M, Huang L, Zhou J, Takamoto M, Pei L, Lu J, Au N, Krevvata M, Usmani SZ, Cohen YC; RedirecTT-1 Investigators Study Group. Dual Targeting of Extramedullary Myeloma with Talquetamab and Teclistamab. N Engl J Med. 2026 Jan 1;394(1):51-61. doi: 10.1056/NEJMoa2514752. Epub 2025 Dec 7.

    PubMed 41358582

  • Cohen YC, Magen H, Gatt M, Sebag M, Kim K, Min CK, Ocio EM, Yoon SS, Chu MP, Rodriguez-Otero P, Avivi I, Quijano Carde NA, Kumar A, Krevvata M, Peterson MR, Di Scala L, Scott E, Hilder B, Vanak J, Banerjee A, Oriol A, Morillo D, Mateos MV; RedirecTT-1 Investigators and Study Group. Talquetamab plus Teclistamab in Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2025 Jan 9;392(2):138-149. doi: 10.1056/NEJMoa2406536.

    PubMed 39778168

  • St Martin Y, Franz JK, Agha ME, Lazarus HM. Failure of CAR-T cell therapy in relapsed and refractory large cell lymphoma and multiple myeloma: An urgent unmet need. Blood Rev. 2023 Jul;60:101095. doi: 10.1016/j.blre.2023.101095. Epub 2023 Apr 29.

    PubMed 37173224

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Talquetamab and Teclistamab in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 40 sites in 7 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 3 inclusion and 4 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 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Spain, Japan, South Korea, Canada and 2 more countries. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Part 1: Number of Participants with Dose Limiting Toxicity (DLT) (time frame: Approximately 5 years 10 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04586426, which also lists 3 linked publications.

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 16 Jan 2026.

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