Recruiting

Phase 2

Teclistamab & TalquetamabOutpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma

Sponsor:

SCRI Development Innovations, LLC

Code:

NCT05972135

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Teclistamab

Talquetamab

Tocilizumab

Oral Dexamethasone

Study Details

Brief summary:

This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients

Conditions

Multiple Myeloma

Study ID

NCT05972135

Start date

Oct 23, 2023

Status verified date

Apr, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Be ≥18 years of age (or the higher legal age in the jurisdiction in which the study is taking place) at the time of informed consent
Has documented diagnosis of MM according to the IMWG diagnostic criteria (Rajkumar 2011).
Teclistamab or Talquetamab + Tocilizumab: has received 2 or more prior MM therapies including a PI, IMiD and CD38 antibody.
Teclistamab + Oral Dexamethasone: has received 1 or more prior MM therapies including a PI, IMiD and/or CD38 antibody.
Teclistamab or Talquetamab + Tocilizumab: has an ECOG performance status (Oken 1982) of 0 to 1.

Teclistamab + Oral Dexamethasone: has an ECOG performance status (Oken 1982) of 0 to 2.

Measurable disease at screening, as assessed by local laboratory, defined by any of the following:

Serum M-protein level ≥0.5 g/dL; or
Urine M-protein level ≥200 mg/24 hours; or
Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm).
Human immunodeficiency virus-positive participants are eligible if they meet all of the following:

No detectable viral load (i.e., <50 copies/mL) at screening
CD4+ count >300 cells/mm3 at screening
No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of screening
Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance/progression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment.
Adequate organ system function
Body weight >35 kg.
A participant of childbearing potential must have a negative highly sensitive serum (β-hCG) at screening and within 72 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.
A participant must agree to abide by protocol defined contraceptive requirements for the duration of the study including avoiding donating gametes for specified period of time.
A participant must sign an ICF indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
A participant is required to stay within 60 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the teclistamab step-up dosing schedules
A participant is required to stay within 30 minutes of transportation to the site and remain in the company of a competent adult at all times until 48 hours following administration of all doses within the talquetamab step-up dosing schedule
A participant must agree to carry the study participant identification wallet card at all times.
A participant must comply with all the protocol requirement procedures, including measuring and recording of body temperature and blood oxygen saturation twice daily (≥8 hours apart) during the first 2 cycles of teclistamab or talquetamab treatment and coming to the study site for safety assessments.
A participant and the accompanying competent adult must be made aware of the presenting sign sand symptoms of teclistamab- or talquetamab- associated toxicities, including but not limited to CRS, ICANS, infections, etc. The accompanying competent adult must watch the participant at all times for teclistamab- or talquetamab- associated toxicities, until 48 hours after the first treatment dose of teclistamab or talquetamab.

Exclusion Criteria:

Has a rapidly progressing disease per investigator assessment.
Has plasma cell leukemia (>2.0×10\^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
Has known active CNS involvement or exhibits clinical signs of meningeal involvement of MM.
Has risk factors for developing clinically significant TLS and requiring management with increased hydration, allopurinol, or rasburicase.
Has myelodysplastic syndrome or active malignancies (ie, progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:

Any malignancy that was not progressing nor requiring treatment change in the last 12 months.
Malignancies treated within the last 12 months and considered at very low risk for recurrence:
Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, <3 cm, no CIS).
Skin cancer (non-melanoma or melanoma).
Noninvasive cervical cancer.
Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, localized breast cancer and receiving antihormonal agents.
Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment).
Other malignancy that is considered at minimal risk of recurrence.
Has Grade ≥3 hematologic AEs or Grade ≥3, clinically significant non-hematologic AEs.
Has fever or active infection (bacterial, viral, or uncontrolled systemic fungal) at time of study enrollment.
Has active autoimmune disease or a documented history of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing.
Has clinically significant coagulopathy that would increase the risk of bleeding in the setting of cytopenia.
Shows a deterioration in neurologic status, including mental status changes such as confusion or increased somnolence.
Has psychiatric disorders (eg, alcohol or drug abuse), dementia, or altered mental status that would compromise the ability to provide informed consent or comply with the clinical protocol.
History of stroke, transient ischemic attack or seizure within 6 months of signing ICF.
Presence of the following cardiac conditions:

New York Heart Association stage III or IV congestive heart failure.
Myocardial infarction or CABG ≤6 months prior to enrollment.
History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.
History of severe non-ischemic cardiomyopathy.
Poorly controlled coronary artery disease and/or congestive heart failure.
Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.
Has hepatitis B infection (ie, HBsAg or HBV-DNA positive). In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status.
Has active hepatitis C infection as measured by positive HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.
Has COPD with FEV1 <50% of predicted.
Has eGFR <20 ml/min or is dependent on dialysis.
Has other medical issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
For talquetamab arm only: Prior Grade 3 or higher CRS related to any T-cell redirection (e.g., CD-3 redirection technology or CAR-T cell therapy), or any prior GPRC5D-targeting therapy.
Has received packed RBC or platelet transfusions within the last 7 days prior to dosing.
Has contraindications to the use of tocilizumab or IVIG per local prescribing information.
Has received live vaccine(s) within 1 month prior to screening or plans to receive live vaccines during the study.
Has received live, attenuated vaccine(s) within 30 days before the first dose of teclistamab or talquetamab. Live, attenuated influenza vaccines are permitted as late as 30 days before the study treatment.
Has received any non-anti-cancer investigational intervention or used any non-anti-cancer invasive investigational medical device within 21 days before the planned first dose of study treatment or received any non-anti-cancer investigational biological product within 21 days or 5 half-lives, whichever is shorter, before the planned study treatment, or is currently enrolled in an investigational study.
History of prior anti-cancer therapy as follows, before the first dose of study drug:

Targeted therapy, epigenetic therapy, or treatment with an investigational anti-cancer drug or used an invasive investigational medical device within 21 days or 5 half-lives, whichever is shorter.
Monoclonal antibody treatment for MM within 21 days.
Cytotoxic therapy within 21 days.
PI therapy within 14 days.
Immunomodulatory agent therapy within 7 days.
Radiotherapy within 14 days or focal radiation within 7 days.
For teclistamab arms only: Prior Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified \[CAR\]-T cells, NK cells, or BCMA therapy)
For talquetamab arm only: Prior CAR-T or BCMA bispecific antibody therapy are allowed with the appropriate wash-out period: 1) Gene modified adoptive cell therapy (eg, chimeric antigen receptor modified \[CAR\]-T cells, NK cells) within 3 months, or 2) BCMA therapies (antibody-drug conjugates and bispecific antibodies, etc) within 21 days or at least 5 half-lives, whichever is less.
History of stem cell transplant:

An allogeneic stem cell transplant within 6 months. Participants who received an allogeneic transplant must be off all immunosuppressive medications for ≥42 days without signs of graft-versus-host disease.
An autologous stem cell transplant ≤12 weeks before the first dose of study drug.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Teclistamab/Tocilizumab

Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy.

experimental: Talquetamab/Tocilizumab

Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm.

experimental: Teclistamab/Oral Dexamethasone

Participants will receive step-up dosing of Teclistamab followed by weekly dosing for two cycles, every other week during Cycles 3-6 and once every 4 weeks from Cycles 7 through 12 until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better starting with Cycle 3.

Interventions

Teclistamab

Teclistamab will be administered subcutaneously at step-up doses on Day 1, Day 4 and Day 8, one week after first treatment dose and weekly thereafter. In participants who have a partial response (PR) or better after 6 months of therapy, dosing frequency may be reduced to every 2 weeks.

Talquetamab

Talquetamab will be administered subcutaneously at step-up doses on Day 1, Day 4, Day 8 and Day 15, one week after first treatment dose and every 2 weeks thereafter. In participants who have a very good partial response (VGPR) or better after Cycle 4, dosing frequency may be reduced to every 4 weeks

Tocilizumab

Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1.

Oral Dexamethasone

Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered.

Primary outcome measure

Incidence of CRS of any grade during the first two cycles [ Time Frame: From first dose of teclistamab or talquetamab, from Day 1 first step-up dose to the end of Cycle 2 (each cycle is 28 days) ]

Central Contacts and Locations

Central contacts

Sarah Cannon Development Innovations, LLC

1-844-710-6157 SCRI.InnovationsMedical@scri.com

Locations

Arizona Oncology Associates

Recruiting

Tucson, Arizona, United States, 85711

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Rocky Mountain Cancer Center

Recruiting

Denver, Colorado, United States, 80218

Medical Oncology Hematology Consultants

Recruiting

Newark, Delaware, United States, 19713

Maryland Oncology Hematology

Recruiting

Columbia, Maryland, United States, 21044

Minnesota Oncology Hematology

Recruiting

Minneapolis, Minnesota, United States, 55404

Virginia Oncology Associates

Recruiting

Elizabeth City, North Carolina, United States, 27909

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45242

Oncology Associates of Oregon

Recruiting

Eugene, Oregon, United States, 97401

TriStar Bone Marrow Transplant

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt- Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Texas Oncology

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Blue Ridge Cancer Center

Recruiting

Roanoke, Virginia, United States, 24014

More Information

Sponsor

SCRI Development Innovations, LLC

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

Teclistamab (TECVAYLI™)
Humanized IgG-4 PAA bispecific antibody
CD3 receptor complex
RRMM-Relapsed or Refractory Multiple Myeloma
MM-Multiple Myeloma
Tocilizumab prophylaxis
CRS- Cytokine Release Syndrome
Neurologic toxicity
ICANS-Immune Effector Cell-associated Neurotoxicity Syndrome
Talquetamab (TALVEY™)
GPRC5D
BCMA
Oral dexamethasone prophylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SCRI Development Innovations, LLC on 2026-04-22.