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Multiple MyelomaPhase 1NCT05431608

A Study of MCARH109 and MCARH125 in People With Multiple Myeloma

A Phase 1 study testing MCARH125 and MCARH109 in people with Multiple Myeloma and Refractory Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

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

A sample of participants' T cells will be sent to a laboratory, where the cells will be made into the study therapy, MCARH109 and MCARH125. Participants will receive either MCARH125 alone or MCARH125 with MCARH109. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MCARH125 and MCARH109
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
7 sitesUnited States
Study dates
20 Jun 2022to 20 Jun 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

  • Patients must have histologically confirmed multiple myeloma (MM) by MSKCC pathologist.
  • Age ≥ 18 years of age
  • Diagnosis of relapsed or refractory MM with at least 3 prior lines of therapy.
  • Refractory myeloma is defined as disease that progresses while on therapy or within 60 days after the last therapy. Relapsed myeloma is defined as previously treated myeloma with initial response and subsequent progression (per International Myeloma Working Group i.e. IMWG criteria) not meeting criteria for refractory disease.
  • At least 3 prior lines of therapy; Prior therapy should include all of the following:
  • A proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib)
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  • An immunomodulatory drug (e.g., thalidomide, lenalidomide, pomalidomide)
  • A CD38 monoclonal antibody (e.g., daratumumab)
  • High dose chemotherapy with autologous stem cell support (ASCT)
  • Subjects who are not candidates to receive one or more of the above treatments (5 a-d) are eligible for the trial.
  • ECOG performance status of 0 or 1
  • HGB ≥ 8 g/dl, ANC≥ 1,000/mm3, Platelet≥ 50,000/mm3 without red cell transfusion for 21 days, platelet transfusion for 7 days and or growth factor support (Neupogen or Neulasta) for at least 14 days prior to initial screening (screening A). HGB ≥ 8 g/dl, ANC ≥ 1,000/mm3, Platelet ≥ 20,000/mm3 prior to pre-treatment screening (screening B). Patients are allowed to receive transfusion support prior to the pre-treatment screening but no growth factor support (Neupogen or Neulasta) for 7 days prior to pre-treatment screening.
  • Measurable disease defined as meeting at least one of the criteria below:
  • Serum M protein ≥ 0.5 g/dL
  • Involved serum free light chain ≥10 mg/dL with an abnormal free light chain ratio
  • Urine M-protein ≥ 200 mg/24 hours
  • Measurable plasmacytomas seen on imaging (≥ 1 lesion that has a single diameter ≥ 2 cm). If this is the primary marker of measurable disease, patients will need a biopsy at the pre-treatment screening (screening B).
  • Bone marrow plasma cells ≥ 30% as determined by CD138 immunohistochemistry staining
  • Serum creatinine ≤ 1.5mg/dL or a measured creatinine clearance ≥ 50 mL/min (using 24-hour urine collection)
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 X ULN and total bilirubin ≤ 2 mg/dL (or < 3 mg/dL for individuals with Gilbert's syndrome)
  • PT and PTT ≤ 1.5 X ULN
  • Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry
  • Adequate cardiac function, defined as LVEF ≥ 40% by transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA) performed within 4 weeks of initial screening
  • For patients with prior ASCT, at least 100 days since ASCT at the time of initial screening.

Who cannot join

  • Pregnant or lactating women. Women and men of childbearing age should use highly effective contraception while on this study and continue for 1 year after all treatment is finished.
  • Patients with following cardiac conditions will be excluded:
  • New York Heart Association (NYHA) stage III or IV congestive heart failure
  • Myocardial infarction ≤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
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  • Patients with HIV or active hepatitis B or hepatitis C infection are ineligible.
  • Current diagnosis of primary and secondary plasma cell leukemia is excluded. History of plasma cell leukemia is not excluded.
  • Patients who have not received any myeloma therapy for the preceding 6 months except if the last myeloma therapy was a CAR T cell therapy.
  • At least 14 day washout from myeloma therapies prior to leukapheresis and prior to starting lymphodepletion. The washout for experimental treatments would be 5 half-lives or 14 days (whichever is shorter).
  • At least 14 day washout from radiation prior to leukapheresis and prior to starting lymphodepletion.
  • Patients treated with previous JCARH125, and/or MCARH109 (any other cellular products that have the same construct) will be excluded. Other CART therapies are not excluded. Prior therapies with other BCMA or GPRC5D targeted therapies including antibody drug conjugates and bispecific antibodies are not excluded.
  • Patients with any concurrent active malignancies (or another primary malignancy not in remission for at least 2 years) as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.
  • Patients with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced GvHD that required systemic steroids or other systemic lymphotoxic therapy within 12 weeks of initial screening
  • Patients on systemic steroids (except if solely for adrenal replacement) within two weeks of collection
  • Active auto-immune disease including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapy
  • Prior or active CNS involvement by myeloma (e.g., leptomeningeal disease). Screening for this, for example, by lumbar puncture, is only required if suspicious symptoms or radiographic findings are present.
  • Pre-existing (active or severe) neurologic disorders (e.g., pre-existing seizure disorder)
  • Active uncontrolled acute infections
  • Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Limited protocol activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack (Limited protocol activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited protocol activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited protocol activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited protocol activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: Phase I Trial of Concurrent Administration of GPRC5D-Targeted CAR T Cell MCARH109 and BCMA-Targeted CAR T Cell MCARH125 in Patients With Relapsed or Refractory Multiple Myeloma

A sample of participants' T cells will be sent to a laboratory, where the cells will be made into the study therapy, MCARH109 and MCARH125. Participants will receive either MCARH125 alone or MCARH125 with MCARH109.

Being tested
MCARH125, MCARH109
Keywords
Multiple Myeloma, Refractory Multiple Myeloma, Relapse Multiple Myeloma, MCARH109, MCARH125, GPRC5D targeted CAR T cell, CAR T cells, Memorial Sloan Kettering Cancer Center, 22-052
Medical subject headings
Multiple Myeloma

What participants receive

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

  • MCARH125Biological

    MCARH109 and MCARH125 will be administered 2-7 days following the completion of conditioning chemotherapy. Each dose cohort will consist of 3-6 patients. MCARH109 and MCARH125 will be administered sequentially with 5-30 minutes between the two products.

  • MCARH109Biological

    MCARH109 and MCARH125 will be administered 2-7 days following the completion of conditioning chemotherapy. Each dose cohort will consist of 3-6 patients. MCARH109 and MCARH125 will be administered sequentially with 5-30 minutes between the two products.

Study groups in NCT05431608
Study groupRoleWhat they receive
Dose Level -1BExperimentalMCARH125 dose 50 million total CAR+ cells MCARH109 dose 50 million total CAR+ cells
Receives: Biological: MCARH125; Biological: MCARH109
Dose Level -1AExperimentalMCARH125 dose 50 million CAR+ cells MCARH109 dose 0 total CAR+ cells
Receives: Biological: MCARH125; Biological: MCARH109
Dose Level 0ExperimentalMCARH125 dose 150 million total CAR+ cells MCARH109 dose 0 total CAR+ cells
Receives: Biological: MCARH125; Biological: MCARH109
Dose Level 1ExperimentalMCARH125 dose 150 million total CAR+ cells MCARH109 dose 50 million total CAR+ cells
Receives: Biological: MCARH125; Biological: MCARH109
Dose Level 2ExperimentalMCARH125 dose 150 million total CAR+ cells MCARH109 dose 150 million total CAR+ cells
Receives: Biological: MCARH125; Biological: MCARH109

What is being measured

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

  1. Maximum tolerated dose/MTS of MCARH109 and MCARH125 T cells

    To determine maximum tolerated dose (MTD) of MCARH109 and MCARH125 T cells in patients with refractory, persistent, or progressive MM.

    Measured: up to 24 months

Timeline

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

  1. First posted24 Jun 2022
  2. Study start20 Jun 2022
  3. Primary completion20 Jun 2027 (estimated)
  4. Study completion20 Jun 2027 (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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431608
Sponsor's protocol ID
22-052
Status last verified
Jul 2026
First submitted
20 Jun 2022
Last updated
6 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Publications

  • Mailankody S, Mitra S, Herrera K, Ziccheddu B, Cadzin B, Eren OC, Farzana T, Ullah T, Landa J, Derkach A, Chaudhari J, McAvoy DP, Hosszu K, Shah GL, Landau H, Maura F, Dogan A, Giralt S, Wang X, Sadelain M, Smith EL, Brentjens RJ, Leslie C, Usmani SZ, Perica K. Concurrent administration of BCMA and GPRC5D CAR T cells for advanced multiple myeloma. Blood. 2026 Oct 22;148(17):2121-2131. doi: 10.1182/blood.2025032122.

    PubMed 42413007

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MCARH125 and MCARH109 in people with Multiple Myeloma and Refractory Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

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 24 inclusion and 20 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. 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?

Maximum tolerated dose/MTS of MCARH109 and MCARH125 T cells (time frame: up to 24 months). 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 NCT05431608, which also lists 1 linked publication.

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 6 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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