A Study of Teclistamab and Mezigdomide in People With Multiple Myeloma

NCT07105059 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 24-393
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 7

Brief Summary

The researchers are doing this study to find out whether combining teclistamab and mezigdomide is a safe and effective treatment approach in people with relapsed/refractory multiple myeloma (MM).

Conditions

Multiple Myeloma

Keywords

Teclistamab; Mezigdomide; Relapsed or refractory multiple myeloma; 24-393; MATRIX (Mezigdomide And Teclistamab to Relieve Immune eXhaustion)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicity Assessed by CTCAE v5.0

  1 year

Secondary Outcomes (1)

• Overall response rate

  2 years

Study Arms (1)

Teclistamab and Mezigdomide

EXPERIMENTAL

The trial treatment will start with 14 days of mezigdomide priming to sensitize the myeloma cells to the bispecific antibody treatment and to stimulate and activate T-cells. After mezigdomide priming, patients will go through the step-up dosing with teclistamab- followed by combination treatment with both drugs.

Drug: Teclistamab; Drug: Mezigdomide

Interventions

Teclistamab DRUG

After the priming, patients will start Teclistamab step up dosing. Mezigdomide will not be given during the Teclistamab step up. After the priming and step-up, patients will start combination treatment with Teclistamab and Mezigdomide.

Teclistamab and Mezigdomide

Mezigdomide DRUG

Start with 14 days of Mezigdomide. After the priming and step-up, patients will start combination treatment with Teclistamab and Mezigdomide.

Teclistamab and Mezigdomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed or refractory multiple myeloma who have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. Patients who have been treated with at least 2 prior lines of therapy are eligible. Multiple myeloma is defined by the International Myeloma Working Group (IMWG) updated criteria.
• Patients need to have measurable disease defined by one or more of the following:
• Serum myeloma (M)-protein greater than or equal to 0.5 g/dL (5 g/L).
• Urine M-protein greater or equal to 200 mg/24 h.
• Involved light chain (either kappa or lambda) \>10 mg/dL with an abnormal kappa: lambda ratio
• Plasmacytoma(s) that is new or definitely increased verified by imaging or biopsy.
• Increase is defined as a 50% and at least 1 cm increase as measured serially by the sum of the products of the cross-diameters of the measurable lesion.
• A bone marrow biopsy demonstrating \>30% infiltration of clonal plasma cells.
• Patients who have received prior BCMA-directed therapy \> 90 days prior including antibody drug conjugates or chimeric antigen receptor T-cell \[CAR T\] are eligible. BCMA presence on the cell surface should be confirmed in patients who have been treated with prior BCMA targeted therapies. Prior treatment with BCMA targeted bispecific antibodies is not allowed.
• Patients who have received bispecific antibodies \>60 days prior with targets other than BCMA are eligible.
• Patients who have received allogeneic stem cell transplantation \>6 months prior are eligible.
• Age ≥18 years.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1. PS-2 is permitted if PS is due solely to bone pain.
• Fulfil the criteria for Adequate Organ System Function Based on Safety Assessments:
• Hematologic:

You may not qualify if:

• Prior treatment with a BCMA targeted bispecific antibody
• Prior treatment with mezigdomide
• Systemic anti-myeloma therapy (including systemic steroids) within ≤14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
• Use of an investigational drug within 21 days or five half-lives (whichever is longer) preceding the first dose of study drug.
• Radiation therapy within ≤14 days prior to study entry (bone lesions requiring radiation may be treated with limited \[i.e., ≤ 25% of bone marrow in field\] radiation therapy during this period).
• Live, attenuated vaccine or investigational vaccine within 4 weeks before the first dose of study drug. Non-live or non-replicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed
• Patients with a history of autologous stem cell transplant within 60 days or allogeneic stem cell transplant within 6 months prior to study enrollment.
• Patients who received CAR T therapy within 90 days prior to study enrollment
• Patients with primary AL amyloidosis will be excluded.
• Participant must not have had major surgery ≤4 weeks prior to initiating study treatment.
• Evidence of active internal bleeding.
• Presence of active renal condition. Participants with isolated proteinuria resulting from multiple myeloma are eligible, provided they fulfill criteria given
• Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
• Subject has active or prior history of malignancy, other than multiple myeloma, unless the subject has been free of the disease or medically stable for ≥ 2 years. The only allowed exceptions are the below listed malignancies treated within the last 24 months and that are considered cured:
• Non-muscle invasive bladder cancer

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Bristol-Myers Squibb: collaborator
• Johnson & Johnson: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Malin Hultcrantz, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin Hultcrantz, MD, PhD

CONTACT

646-608-3714; hultcram@mskcc.org

Ross Firestone, MD, PhD, MS

CONTACT

646-608-2014

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will enroll a total of 18 patients, combined for the dose escalation and expansion cohorts, over a 24 month period.

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): August 8, 2028
• Study Completion (Estimated): August 8, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (7)