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Multiple MyelomaPhase 1NCT05976555

Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma

A Phase 1 study testing BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg), BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg) and BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg) in people with Multiple Myeloma, run by Medical College of Wisconsin at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and efficacy of interleukin-7(IL-7) / interleukin-15 (IL-15) manufactured CAR T cells in adult patients with relapsed and/or refractory myeloma that have failed prior therapies. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Multiple Myeloma
What is being tested?
BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg), BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg) and BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
15 May 2026to May 2029
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be aged ≥18 years to 80 years old.
  • Patients must have received three prior lines of therapies, including proteasome inhibitor, immunomodulator and a cluster of differentiation (CD) 38 monoclonal antibody:
  • International Myeloma Working Group (IMWG) criteria defines refractory disease as disease progression on or within 60 days of receiving therapy.
  • Patients must have measurable disease, including at least one or more of the following criteria:
  • Serum M-protein ≥0.5 g/dl;
  • Urine M-protein ≥200 mg/24 hrs;
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  • Involved serum light chain ≥100 mg/L with abnormal light chain ratio;
  • Absolute CD 3 count ≥50 mm^3.
  • Karnofsky performance score ≥70.
  • Adequate hepatic function, defined as:
  • aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase <3x upper limit of normal (ULN);
  • Serum bilirubin <2.0 mg/dL except for patients with Gilbert's syndrome, who must have serum bilirubin of <3 mg/dL.
  • Absolute neutrophil count (ANC) ≥1,000 with no Granulocyte colony-stimulating factor (G-CSF) within 72 hours or pegylated G-CSF within 10 days.
  • Platelets ≥50,000/µL with no transfusion within 72 hours of eligibility testing.
  • Adequate renal function, defined as creatinine clearance ≥50 mL/min calculated using the Cockroft-Gault formula.
  • Able to provide written informed consent.
  • Agree to practice birth control during the study.
  • Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by cardiac echocardiogram (ECHO) or multigated acquisition (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥90%.
  • Expected survival >12 weeks.
  • Negative urine or serum pregnancy test in females of childbearing potential at study entry.
  • Meet criteria for regarding fertility and contraception detailed below.
  • No contraindication to central line access.
  • Phase I Dose-Expansion Cohort A: BCMA Naïve The inclusion criteria for dose-expansion Cohort A are the same as that listed above but are limited to BCMA naïve patients.
  • Phase I Dose-Expansion Cohort B: BCMA Exposed The inclusion criteria for dose expansion Cohort B are the same as that above but require prior exposure to BCMA directed therapies (e.g., CAR-BCMA, bispecific T/ Natural Killer (NK) cell engagers of BCMA).
  • Patients with prior antibody drug conjugate, bispecific T and NK cell engager and prior gene-modified cellular immune therapy against BCMA are allowed. Patients must be > 3 months out from therapy and must have achieved stable disease or better with prior BCMA-directed therapy.

Who cannot join

  • Positive beta- Human chorionic gonadotropin (HCG) in female of child-bearing potential defined as per the Schedule of Events table.
  • Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.
  • History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as >20 mg of prednisone or equivalent daily.
  • Presence of ≥ Grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.
  • Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.
  • Refusal to participate in the long-term follow-up protocol.
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  • Patients with active central nervous system (CNS) involvement by malignancy on MRI or by lumbar puncture.
  • Patients with prior CNS disease that has been effectively treated will be eligible providing last treatment was ≥2 weeks before apheresis and a remission documented within 4 weeks of planned CAR T-cell infusion by MRI brain and CSF analysis.
  • Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are <6 months post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.
  • Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, and AL amyloidosis.
  • Prior treatment with gene therapy or any gene modified cellular therapy (only permitted in cohort B for the dose expansion phase).
  • Prior BCMA-directed therapy (only permitted in cohort B for the dose expansion phase).
  • Cytotoxic chemotherapy, oral chemotherapeutic agents, or antibody-directed treatment within 14 days of apheresis or after apheresis.
  • Corticosteroids are allowable up until 7 days prior to apheresis and after apheresis for disease control up until the day prior to cell infusion (Day -1).
  • Radiation is allowed to a single symptomatic site.
  • Patients post solid organ transplant who develop high grade lymphomas or leukemias.
  • Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
  • Active bacterial, viral, or fungal infection requiring systemic treatment.
  • Patients who have received major surgery 1 week prior to leukapheresis and 3 weeks prior to lymphodepletion.
  • Active malignancy that required therapy in the last 2 years except successfully treated non metastatic basal or squamous cell carcinoma, or prostate carcinoma that does not require therapy. Other similar conditions may be discussed with and permitted by the medical monitor.
  • Special Criteria Regarding Fertility and Contraception
  • Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure [hysterectomy or bilateral oophorectomy]) must have a negative serum or urine pregnancy test performed as part of eligibility criteria. Lactating women are eligible for this study but will be asked to not provide breast milk to their child from Day -4 through Day +90 after CAR T-cell therapy.
  • Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.
  • Acceptable birth control includes a combination of two of the following methods:
  • Condoms (male or female) with or without a spermicidal agent.
  • Diaphragm or cervical cap with spermicide.
  • Intrauterine device (IUD).
  • Hormonal-based contraception. Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation, salpingectomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Medical College of Wisconsin Cancer Center Clinical Trials Office contact

866-680-0505 ext. 8900

cccto@mcw.edu

United States1 site, 1 recruiting

  • Froedtert & the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Binod Dhakal, MD, 414-805-4600, bdhakal@mcw.edu

    Binod Dhakal, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase I Study of BCMA-TGF-BETA Insensitive Armored CAR T Cells in Patients With Relapsed and/or Refractory Multiple Myeloma

This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and efficacy of interleukin-7(IL-7) / interleukin-15 (IL-15) manufactured CAR T cells in adult patients with relapsed and/or refractory myeloma that have failed prior therapies.

Read the detailed description

BCMA-Transforming growth factor-beta (TGFβ) CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Patients will receive one of three dose levels of BCMA-TGFβ CAR-T cells based on our dose escalation design.

After the maximal tolerated dose (MTD) is determined, an additional dose-expansion cohort of up to 9 patients (3 BCMA-naïve and 6 BCMA exposed) may be enrolled at that dose to further describe the safety and preliminary efficacy of that dose.

Being tested
BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg), BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg), BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg), BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg), Maximum tolerated dose
Keywords
CAR-T, Chimeric antigen receptor T-cell therapy, CAR Therapy
Medical subject headings
Multiple Myeloma

What participants receive

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

  • BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)Biological

    This is dose level 0 (de-escalation).

  • BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)Biological

    This is dose level 1, the starting dose.

  • BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)Biological

    This is dose level 2.

  • BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)Biological

    This is dose level 3.

  • Maximum tolerated doseBiological

    The maximum tolerated dose is yet to be determined.

Study groups in NCT05976555
Study groupRoleWhat they receive
BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)ExperimentalBCMA-TGFβ CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of four dose levels of BCMA-TGFβ CAR-T cells based on the dose escalation design.
Receives: Biological: BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg)
BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)ExperimentalBCMA-TGFβ CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of four dose levels of BCMA-TGFβ CAR-T cells based on the dose escalation design.
Receives: Biological: BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg)
BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)ExperimentalBCMA-TGFβ CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of four dose levels of BCMA-TGFβ CAR-T cells based on the dose escalation design.
Receives: Biological: BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg)
BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)ExperimentalBCMA-TGFβ CAR-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Subjects will receive one of four dose levels of BCMA-TGFβ CAR-T cells based on the dose escalation design.
Receives: Biological: BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg)
BCMA-TGFβ CAR-T cells (Maximum tolerated dose)ExperimentalAfter the maximal tolerated dose (MTD) is determined, an additional dose-expansion cohort of up to 9 patients (3 BCMA-naïve and 6 BCMA exposed) may be enrolled at that dose.
Receives: Biological: BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg); Biological: BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg); Biological: BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg); Biological: BCMA-TGFβ CAR-T cells (2.5 x 10^6 cells/kg); Biological: Maximum tolerated dose

What is being measured

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

  1. Number of Adverse Events After BCMA-TGFβ CAR-T Cell Infusion

    Incidence of adverse events with grade 3 to 5 severity using NCI CTCAE version 5.0 and the Lee et al. consensus manuscript (which outlines the defining characteristics of each grade for cytokine release syndrome; please refer to the reference below).

    Measured: from infusion until Day +28 post CAR T infusion

Timeline

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

  1. First posted4 Aug 2023
  2. Study start15 May 2026
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2029 (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
Sequential
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05976555
Sponsor's protocol ID
PRO00056787
Status last verified
Aug 2026
First submitted
28 Jul 2023
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.

    PubMed 30592986

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCMA-TGFβ CAR-T cells (0.50 x 10^6 cells/kg), BCMA-TGFβ CAR-T cells (0.75 x10^6 cells/kg) and BCMA-TGFβ CAR-T cells (1 x 10^6 cells/kg) in people with Multiple Myeloma, run by Medical College of Wisconsin at 1 site 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 25 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events After BCMA-TGFβ CAR-T Cell Infusion (time frame: from infusion until Day +28 post CAR T infusion). 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 NCT05976555, 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 10 Aug 2026.

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