17 Talquetamab (Talvey) Clinical Trials Recruiting Now (June 2026): GPRC5D × CD3 Bispecific, MonumenTAL-3, Tal-DR Newly Diagnosed, Post-BCMA Sequencing, SubQ Administration

Last updated: June 14, 2026

📌 Why this page exists: Talquetamab (Talvey) is the first-in-class GPRC5D-targeted T-cell engager approved for multiple myeloma, opening a non-BCMA target class for patients whose disease has relapsed after BCMA-directed therapy. Most recruiting trials are testing earlier-line combinations, post-BCMA sequencing, and subcutaneous administration. For the full multiple myeloma trial landscape (BCMA bispecifics, GPRC5D, cevostamab FcRH5, CAR-T, CELMoDs, smoldering), see our multiple myeloma trials page.

About Talquetamab (Talvey)

Drug profile:

Talquetamab (brand name Talvey, code JNJ-64407564, USAN talquetamab-tgvs) is a first-in-class GPRC5D × CD3 bispecific T-cell engager developed by Janssen Biotech / Johnson & Johnson. One arm binds GPRC5D (G-protein coupled receptor class C group 5 member D — an orphan GPCR highly expressed on plasma-cell-lineage tumor cells) and the other arm binds CD3 on T cells, redirecting the patient's own T cells to attack GPRC5D-expressing myeloma cells. Talquetamab is administered as a subcutaneous injection with step-up dosing in cycle 1, on either a weekly or every-other-week schedule depending on the regimen.

Why GPRC5D matters as a target:

Before talquetamab, all approved CD3-engaging bispecifics in multiple myeloma targeted BCMA (teclistamab, elranatamab, linvoseltamab). GPRC5D is the first non-BCMA target class to reach approval, which matters clinically because patients whose disease progresses on a BCMA bispecific or BCMA CAR-T need a target outside that class to respond. Talquetamab — and the broader GPRC5D class (etentamig; the BCMA × GPRC5D dual-bispecific JNJ-79635322 now in Phase 3) — is what makes that sequencing possible. The FcRH5 × CD3 bispecific cevostamab, now in Phase 3, is the second non-BCMA, non-GPRC5D target class entering MM.

Regulatory status:

FDA accelerated approval, August 9, 2023 — for adults with relapsed or refractory multiple myeloma after at least four prior lines of therapy including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Approval was based on the Phase 1/2 MonumenTAL-1 study (NCT03399799 / NCT04634552 continuation). Accelerated approval requires confirmatory Phase 3 data; the Phase 3 confirmatory program (including NCT06208150 in earlier-line RRMM and Phase 3 trials in newly diagnosed MM) is ongoing. We do not claim full (traditional) approval on this page — readers should check the current FDA prescribing information.
Outside the US: conditional marketing authorization in the EU (Aug 2023) and approvals in several other jurisdictions on the same MonumenTAL-1 dataset.

Active Research Directions in 2026

Phase 3 in earlier-line RRMM (post anti-CD38 + lenalidomide) — NCT06208150 (sponsor protocol 64407564MMY3009) is the most consequential trial for moving talquetamab out of the late-line setting. Three arms: talquetamab + pomalidomide (Tal-P), talquetamab + teclistamab (Tal-Tec), and investigator's choice of EPd (elotuzumab + pomalidomide + dexamethasone) or PVd (pomalidomide + bortezomib + dexamethasone). Enrolls RRMM patients who have received an anti-CD38 antibody and lenalidomide. If positive, this trial moves talquetamab into 1–3 prior line settings and establishes the Tal-P and Tal-Tec doublets as treatment options.
Phase 3 in transplant-ineligible newly diagnosed MM — NCT05552222 (MajesTEC-7 family) compares Tec-DR (teclistamab + daratumumab + lenalidomide) and Tal-DR (talquetamab + daratumumab + lenalidomide) head-to-head against DRd (daratumumab + lenalidomide + dexamethasone) in newly diagnosed transplant-ineligible MM. This is the cleanest direct comparison of a BCMA bispecific induction vs a GPRC5D bispecific induction in the same trial.
Transplant-eligible newly diagnosed MM (MajesTEC-5) — NCT05695508 evaluates teclistamab-, talquetamab-, and JNJ-79635322-based combination regimens as induction and post-transplant maintenance.
Post-BCMA sequencing — two trials directly answer the "what comes after BCMA?" question: NCT06066346 (talquetamab consolidation after BCMA CAR-T idecabtagene vicleucel / ide-cel) and NCT07093554 (Cilta-Talq Fusion — talquetamab as bridging therapy before ciltacabtagene autoleucel / cilta-cel). Patients whose disease has progressed on BCMA-directed therapy can ask their care team about either trial.
Earlier-line combinations with CELMoDs — NCT06348108 (talquetamab + iberdomide + dexamethasone, Phase 1b) and NCT07032714 (MAGENTA: talquetamab + mezigdomide, Phase 1) test talquetamab paired with the next-generation cereblon modulators in RRMM, including patients with BCMA exposure.
Subcutaneous talquetamab in elderly early relapse — NCT06827860 tests subcutaneous talquetamab as a single agent in elderly patients in early relapse, addressing the population where triple-class refractory disease emerges earlier and median overall survival is short.
Outpatient administration — NCT05972135 evaluates whether teclistamab or talquetamab can be safely administered in the outpatient setting (the FDA label currently requires hospitalization for the step-up doses, the main operational bottleneck for adoption).
Extramedullary disease — NCT06572605 combines concurrent external beam radiation with talquetamab for multiple myeloma patients with extramedullary disease (a particularly difficult-to-treat population).
Smoldering myeloma (early intervention) — the REVIVE study (NCT06100237) tests teclistamab or talquetamab in combination with daratumumab in high-risk smoldering myeloma. Part of the broader trend of moving T-cell engagers before active MM.
MRD-driven response-adaptive consolidation — ROTATE (NCT06993675) and NCT06505369 use sequential talquetamab + teclistamab as consolidation in newly diagnosed MM to eliminate minimal residual disease.
Preventive management of GPRC5D-related oral side effects — NCT06500884 is a Phase 2 trial dedicated to preventive treatments for talquetamab-related dysgeusia (taste changes), which is the most patient-noticeable, talquetamab-specific side effect.

Recruiting Trials by Setting

Phase 3 — Earlier-Line RRMM and Newly Diagnosed MM (2 trials)

The two Phase 3 trials below are the registrational program that will determine whether talquetamab moves out of the 4+ prior line setting into earlier lines of therapy. Both are sponsored by Janssen.

NCT06208150 — 64407564MMY3009 (Phase 3; Recruiting): Talquetamab + pomalidomide (Tal-P) vs talquetamab + teclistamab (Tal-Tec) vs investigator's choice of elotuzumab + pomalidomide + dexamethasone (EPd) or pomalidomide + bortezomib + dexamethasone (PVd) in participants with RRMM who have received an anti-CD38 antibody and lenalidomide. The earlier-line registrational trial; if positive, moves talquetamab into the 1–3 prior line space.
NCT05552222 — Tec-DR / Tal-DR vs DRd (Phase 3; Recruiting): Teclistamab + daratumumab + lenalidomide (Tec-DR) and talquetamab + daratumumab + lenalidomide (Tal-DR) vs daratumumab + lenalidomide + dexamethasone (DRd) in newly diagnosed MM, transplant-ineligible or not intended for ASCT as initial therapy. Direct comparison of BCMA bispecific induction vs GPRC5D bispecific induction in the same trial.

Newly Diagnosed and Transplant Setting (Phase 2) (6 trials)

NCT05695508 — MajesTEC-5 / GMMG-HD10 / DSMM-XX (Phase 2; Recruiting): Teclistamab-, talquetamab-, and JNJ-79635322-based combination regimens as induction and post-transplant maintenance in newly diagnosed transplant-eligible MM.
NCT06461988 — OPTIMMAL (Phase 2; Recruiting): Talquetamab + lenalidomide as post-stem-cell-transplant maintenance in multiple myeloma. Tests whether GPRC5D-targeted maintenance can deepen and prolong response after ASCT.
NCT06505369 — Bispecific T-cell Redirector Consolidation (Phase 2; Recruiting): Talquetamab and teclistamab in sequence as consolidation in transplant-eligible newly diagnosed MM, with the goal of improving MRD-negative complete response rates.
NCT06993675 — ROTATE (Phase 2; Recruiting): Response-adaptive consolidation in newly diagnosed MM — participants who remain MRD-positive after front-line induction + transplant receive consolidation with talquetamab and/or teclistamab to convert to MRD-negative.
NCT07107529 — EMN 37 FITFIX FOR FRAIL (Phase 2; Recruiting): Daratumumab + teclistamab or daratumumab + talquetamab as fixed-duration treatment for frail patients with newly diagnosed MM. Two parallel cohorts (Tec-D vs Tal-D).
NCT06100237 — REVIVE (Phase 2; Recruiting): Teclistamab or talquetamab in combination with daratumumab SC for high-risk smoldering myeloma. Early-intervention trial — treating myeloma before it becomes symptomatic.

Late-Line / Triple-Class Refractory RRMM (Phase 1/2) (4 trials)

The currently-approved setting (4+ prior lines including anti-CD38 + PI + IMiD) and adjacent triple-class refractory combinations:

NCT04634552 — MonumenTAL-1 Phase 1/2 (Recruiting): First-in-human, open-label dose-escalation and recommended Phase 2 dose study of talquetamab in RRMM. The pivotal study supporting the August 2023 FDA accelerated approval; continues to recruit at the recommended Phase 2 dose(s).
NCT06348108 — Talquetamab + Iberdomide + Dexamethasone (Phase 1b; Recruiting): For RRMM that is triple-class refractory and has BCMA exposure — the population with limited options and poor survival.
NCT07032714 — MAGENTA (Phase 1; Recruiting): Mezigdomide + talquetamab in RRMM. Sequence: talquetamab + dex first, then add mezigdomide (Cohort A); or mezigdomide + dex first, then add step-up talquetamab (Cohort B).
NCT06827860 — Subcutaneous Talquetamab in Elderly Early Relapse (Phase 2; Recruiting): Single-arm SubQ talquetamab in elderly patients with MM in early relapse after triple- or quadruple-drug induction. Addresses the rapidly-emerging triple-class-refractory elderly population.

Post-BCMA Sequencing (2 trials)

A critical practical question in 2026 MM care — what comes after a BCMA bispecific or BCMA CAR-T? Talquetamab (a non-BCMA target) is one of the leading sequencing options:

NCT06066346 — Talquetamab Consolidation After BCMA CAR-T (Phase 2; Recruiting): Talquetamab in patients who have already received the BCMA CAR-T idecabtagene vicleucel (ide-cel) for RRMM. Tests whether GPRC5D engagement deepens or prolongs the response to a prior BCMA CAR-T.
NCT07093554 — Cilta-Talq Fusion (Phase 1b; Recruiting): Talquetamab as bridging therapy followed by ciltacabtagene autoleucel (cilta-cel) BCMA CAR-T in RRMM. Tests safety and feasibility of using a GPRC5D bispecific to control disease during the manufacturing window before BCMA CAR-T infusion.

Extramedullary Disease (1 trial)

NCT06572605 — EBRT + Talquetamab for Extramedullary MM (Phase 1b/2; Recruiting): External beam radiation therapy as a priming step combined with talquetamab for multiple myeloma patients with extramedullary disease (soft-tissue / organ infiltration by plasma cells), a particularly difficult-to-treat population.

Administration Optimization and Supportive Care (2 trials)

NCT05972135 — Outpatient Administration of Teclistamab or Talquetamab (Phase 2; Recruiting): Tests whether step-up dosing and subsequent administration can be done safely in the outpatient setting, which would eliminate the FDA-required hospitalization for the cycle-1 step-up doses — the main operational bottleneck for adoption.
NCT06500884 — Preventive Treatments for GPRC5D-Related Oral Events (Phase 2; Recruiting): A randomized study to identify treatments that prevent or minimize talquetamab-related dysgeusia (taste changes) — the most patient-noticeable, talquetamab-specific side effect. Also includes ramantamig (another GPRC5D-targeted agent) in evaluating GPRC5D-related taste changes.

Showing all 17 recruiting interventional trials of talquetamab in the ClinTrialFinder corpus as of June 14, 2026. View the latest talquetamab search on ClinicalTrials.gov.

Trials Not Yet Recruiting

NCT07029776 — MMulti-Immune HR (Phase 2; Not Yet Recruiting): Sequential bispecific antibody (teclistamab and talquetamab at different time points) to improve progression-free survival in patients with high-risk newly diagnosed MM. Includes induction chemo, stem cell collection, two immunotherapy phases, and MRD-driven decision on melphalan-based transplant.

Note: a single non-oncology talquetamab Phase study in refractory generalized myasthenia gravis (NCT07499323) is also Not Yet Recruiting; we list it here for transparency but it is outside the scope of this oncology page.

Patient Selection and Practical Considerations

GPRC5D expression is not measured before treatment — unlike some biomarker-driven therapies, FDA-approved use of talquetamab does not require pre-treatment confirmation of GPRC5D expression. Expression is presumed in myeloma plasma cells. Some research trials enrich by expression level.
Hospitalization is required for the step-up doses — per the current FDA label, the cycle-1 step-up doses are administered with inpatient monitoring for cytokine release syndrome. Outpatient administration is being tested in NCT05972135.
Step-up dosing schedule — the cycle-1 schedule involves two priming (step-up) doses several days apart, followed by the full treatment dose. Schedules differ between weekly and every-other-week regimens.
Prior BCMA-directed therapy is allowed (and is the topic of several trials) — patients who progressed on a BCMA bispecific or BCMA CAR-T can be considered for talquetamab as the next line. NCT06066346 and NCT07093554 specifically enroll post-BCMA patients.
Infection risk — like other CD3 bispecifics, talquetamab causes immune suppression (including hypogammaglobulinemia). Prophylactic antimicrobials, IVIG replacement, and infection monitoring are typically part of supportive care.
Dose holidays for dysgeusia or skin/nail events — the lower incidence and reversibility of dysgeusia on less-frequent dosing schedules is one of the reasons every-other-week regimens are being studied, and one reason patients sometimes take treatment breaks.

Side Effects (Talquetamab-Specific Signals)

Talquetamab has a distinct side-effect profile that reflects where GPRC5D is normally expressed — in addition to plasma cells, GPRC5D is present on keratinized tissues (skin, nail, tongue). These talquetamab-specific signals are different from the BCMA bispecific class (teclistamab, elranatamab, linvoseltamab):

Dysgeusia (taste changes / taste loss) — the most patient-noticeable, talquetamab-specific side effect. Can affect oral intake, weight, and quality of life. Often partial dysgeusia rather than total ageusia. NCT06500884 is a dedicated Phase 2 trial of preventive treatments.
Skin changes — rash, dry skin, palmar-plantar desquamation (skin peeling on palms and soles). Generally manageable with skin care and topical agents.
Nail changes — ridging, brittleness, discoloration. Cosmetic but bothersome; nails recover after treatment is paused or stopped.
Cytokine release syndrome (CRS) — mostly Grade 1–2, concentrated in cycle 1 step-up doses, generally manageable with tocilizumab, supportive care, and dose modification. Shared with all CD3-engaging bispecifics.
Immune effector cell-associated neurotoxicity syndrome (ICANS) — less frequent than with BCMA CAR-T, generally reversible.
Infections — including opportunistic infections; managed with prophylaxis, IVIG, and monitoring.
Cytopenias — neutropenia, anemia, thrombocytopenia; usually manageable with supportive care.

For the patient-noticeable side effects in particular (taste, skin, nails), it is worth asking your care team in advance about supportive care expectations and dose-modification options — these are the events that drive treatment breaks or schedule changes in practice.

Frequently Asked Questions

What is talquetamab (Talvey)?

Talquetamab (brand name Talvey, development code JNJ-64407564, USAN talquetamab-tgvs) is a first-in-class GPRC5D × CD3 bispecific T-cell engager developed by Janssen Biotech / Johnson & Johnson. One arm binds GPRC5D — an orphan G-protein coupled receptor highly expressed on plasma-cell-lineage tumor cells — and the other binds CD3 on T cells, redirecting the patient's own T cells against GPRC5D-expressing myeloma cells. It received FDA accelerated approval on August 9, 2023 for adults with relapsed or refractory multiple myeloma who had received at least four prior lines of therapy including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The approval was based on the Phase 1/2 MonumenTAL-1 study. Talquetamab is given subcutaneously with step-up dosing in cycle 1.

What cancers is talquetamab being tested in?

Talquetamab is being developed almost exclusively for multiple myeloma and related plasma-cell disorders. GPRC5D is an orphan G-protein coupled receptor with highly restricted expression — mainly on plasma cells (malignant and normal), keratinized tissues (skin, nail, tongue), and a few other tissues. Outside multiple myeloma, talquetamab is being studied in one early trial in refractory generalized myasthenia gravis (NCT07499323), but oncology development is focused on plasma-cell malignancies. The 17 recruiting trials in our corpus span newly diagnosed MM (transplant-eligible and -ineligible), smoldering myeloma, relapsed/refractory MM after one or more prior lines, post-BCMA sequencing, post-stem-cell-transplant maintenance, extramedullary disease, and preventive management of GPRC5D-related oral side effects.

What talquetamab trials are currently recruiting?

There are 17 recruiting interventional talquetamab trials as of June 2026. The two Phase 3 trials are NCT06208150 (Tal-P or Tal-Tec vs investigator's choice EPd / PVd in RRMM after anti-CD38 + lenalidomide) and NCT05552222 (Tec-DR / Tal-DR vs DRd in transplant-ineligible newly diagnosed MM). Newly diagnosed and transplant setting: MajesTEC-5 (NCT05695508), OPTIMMAL post-ASCT maintenance (NCT06461988), Tal+Tec consolidation (NCT06505369), ROTATE MRD-positive consolidation (NCT06993675), FITFIX FOR FRAIL (NCT07107529), REVIVE high-risk smoldering myeloma (NCT06100237). Late-line / RRMM: MonumenTAL-1 (NCT04634552, still recruiting at the recommended Phase 2 dose), Talq + iberdomide + dex (NCT06348108), MAGENTA mezigdomide + talquetamab (NCT07032714), subcutaneous talquetamab in elderly early relapse (NCT06827860). Post-BCMA sequencing: talquetamab after BCMA CAR-T ide-cel (NCT06066346), Cilta-Talq Fusion (NCT07093554). Specialized: EBRT + talquetamab for extramedullary disease (NCT06572605), outpatient administration (NCT05972135), and a Phase 2 trial of preventive treatments for GPRC5D-related dysgeusia (NCT06500884).

What are the main side effects of talquetamab?

Talquetamab has a distinct side-effect profile that reflects where GPRC5D is normally expressed — in addition to plasma cells, GPRC5D is on keratinized tissues (skin, nail, tongue). The most talquetamab-specific (and patient-noticeable) events are dysgeusia (taste changes / taste loss), skin changes (rash, dry skin, palmar-plantar desquamation), and nail changes. These are distinct from BCMA bispecifics (teclistamab, elranatamab) — common enough that a dedicated Phase 2 trial (NCT06500884) is testing preventive treatments for GPRC5D-related oral events. Like other CD3 bispecifics, talquetamab also carries a cytokine release syndrome (CRS) risk (mostly Grade 1–2, concentrated in cycle 1 step-up doses), and a smaller risk of immune effector cell-associated neurotoxicity syndrome (ICANS). Infections (including opportunistic infections) and cytopenias are also possible. The FDA label requires hospitalization for the step-up doses; outpatient administration is being studied in NCT05972135.

Find Talquetamab and GPRC5D-Targeted Trials Matched to Your Situation

Use ClinTrialFinder's AI-powered matching to find talquetamab and other GPRC5D-targeted multiple myeloma trials based on your prior treatments (anti-CD38, IMiD, PI, BCMA bispecific, BCMA CAR-T), transplant status, and disease stage.

Find Matching Trials

This page is for information only and is not medical advice. ClinTrialFinder helps you find clinical trials that may match your situation, but enrollment decisions and treatment choices should always be made with your oncologist or hematologist. Trial eligibility, recruitment status, and treatment details can change — verify directly with the trial sponsor or on ClinicalTrials.gov before acting on any information here.