Relapse Multiple MyelomaPhase 1NCT07221032
FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing FT836 CAR T cells (1 x 10^8 cells per dose), FT836 CAR T cells (3 x 108 cells per dose) and FT836 CAR T cells (up to 9 x 108 cells per dose) in people with Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Relapse Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- FT836 CAR T cells (1 x 10^8 cells per dose), FT836 CAR T cells (3 x 108 cells per dose) and FT836 CAR T cells (up to 9 x 108 cells per dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to Mar 2030
- 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 ≥18 years and < 80 years old.
- Patients must have received >=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:
- International Myeloma Working Group (IMWG) criteria define 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;
- Karnofsky performance score ≥70.
- Adequate hepatic function, defined as:
- Aspartate aminotransferase (AST), alanine aminotransferase (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 G-CSF within 72 hours or pegylated G-CSF within 10 days.
- Platelets ≥50,000 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 scan (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.
- No contraindication to central line access. 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 the eligibility criteria. Lactating women are eligible for this study but will be asked not to provide breast milk to their child from Day -11 through Day +90 after CAR T-cell therapy. It is possible they may no longer be able to lactate after receiving chemotherapy and treatment.
- 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.
Who cannot join
- Positive beta-Human Chorionic Gonadotropin (HCG) in female of child-bearing potential.
- 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 Common Terminology Criteria for Adverse Events (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 in another therapeutic clinical trial at any institution. A minimum of 14 days or five half-lives of the drug (whichever is shorter) washout prior to start of daratumumab.
- 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 magnetic resonance imaging (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 start of daratumumab and a remission documented within four weeks of planned CAR T-cell infusion by MRI brain and Cerebrospinal Fluid (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.
- Cytotoxic chemotherapy, oral chemotherapeutic agents, or antibody-directed treatment within 14 days of starting daratumumab or after starting daratumumab.
- Corticosteroids are allowable up until seven days prior to starting daratumumab and after starting daratumumab 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 one week prior to starting daratumumab and three weeks prior to lymphodepletion.
- Active malignancy that required therapy in the last two 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.
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
United States1 site, 1 recruiting
- Recruiting
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Binod Dhakal, MD, 414-805-4600, bdhakal@mcw.edu
About this study
Official title: Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab 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 preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.
- Being tested
- FT836 CAR T cells (1 x 10^8 cells per dose), FT836 CAR T cells (3 x 108 cells per dose), FT836 CAR T cells (up to 9 x 108 cells per dose), Daratumumab 16 mg/kg
- Keywords
- multiple myeloma, CAR-T 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.
FT836 CAR T cells (1 x 10^8 cells per dose)Biological
FT836 CAR T cells will be administered by IV injection.
FT836 CAR T cells (3 x 108 cells per dose)Biological
FT836 CAR T cells will be administered by IV injection.
FT836 CAR T cells (up to 9 x 108 cells per dose)Biological
FT836 CAR T cells will be administered by IV injection.
Daratumumab 16 mg/kgDrug
Also called DARZALEX
Daratumumab will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| FT836 CAR T cells (1 x 10^8 cells per dose) | Experimental | This is Dose Level 0 (de-escalation dose). Receives: Biological: FT836 CAR T cells (1 x 10^8 cells per dose); Drug: Daratumumab 16 mg/kg |
| FT836 CAR T cells (3 x 108 cells per dose) | Experimental | This is Dose Level 1 (starting dose). Receives: Biological: FT836 CAR T cells (3 x 108 cells per dose); Drug: Daratumumab 16 mg/kg |
| FT836 CAR T cells (up to 9 x 108 cells per dose) | Experimental | This is Dose Level 2, which is ≤3 times Dose Level 1. Receives: Biological: FT836 CAR T cells (up to 9 x 108 cells per dose); Drug: Daratumumab 16 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3 or higher adverse events
This measure is the number of Grade 3 or higher adverse events possibly, probably, or definitely related to the study therapy. Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded and assessed using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading systems. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) will be graded and assessed using the ASTCT panel guidelines.
Measured: start of therapy through 30 days after the end of study therapy, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start5 Aug 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binod Dhakal, Medical College of Wisconsin
- Investigators
- Binod Dhakal, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221032
- Sponsor's protocol ID
- IIT-DHAKAL-FT836-DARA
- Status last verified
- Nov 2026
- First submitted
- 23 Oct 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07221032
- Acronym / sponsor ID
- IIT-DHAKAL-FT836-DARA
- Keywords
- multiple myeloma, CAR-T therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FT836 CAR T cells (1 x 10^8 cells per dose) | Experimental | Biological: FT836 CAR T cells (1 x 10^8 cells per dose), Drug: Daratumumab 16 mg/kgThis is Dose Level 0 (de-escalation dose). |
| FT836 CAR T cells (3 x 108 cells per dose) | Experimental | Biological: FT836 CAR T cells (3 x 108 cells per dose), Drug: Daratumumab 16 mg/kgThis is Dose Level 1 (starting dose). |
| FT836 CAR T cells (up to 9 x 108 cells per dose) | Experimental | Biological: FT836 CAR T cells (up to 9 x 108 cells per dose), Drug: Daratumumab 16 mg/kgThis is Dose Level 2, which is ≤3 times Dose Level 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients must ≥18 years and < 80 years old.
- Patients must have received >=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:
- Patients must have measurable disease, including at least one or more of the following criteria:
- Karnofsky performance score ≥70.
- Adequate hepatic function, defined as:
Key exclusion criteria (19 listed)
- Positive beta-Human Chorionic Gonadotropin (HCG) in female of child-bearing potential.
- 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 Common Terminology Criteria for Adverse Events (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 in another therapeutic clinical trial at any institution. A minimum of 14 days or five half-lives of the drug (whichever is shorter) washout prior to start of daratumumab.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT836 CAR T cells (1 x 10^8 cells per dose)FT836 CAR T cells will be administered by IV injection. | Biological | FT836 CAR T cells (1 x 10^8 cells per dose) |
| FT836 CAR T cells (3 x 108 cells per dose)FT836 CAR T cells will be administered by IV injection. | Biological | FT836 CAR T cells (3 x 108 cells per dose) |
| FT836 CAR T cells (up to 9 x 108 cells per dose)FT836 CAR T cells will be administered by IV injection. | Biological | FT836 CAR T cells (up to 9 x 108 cells per dose) |
| Daratumumab 16 mg/kgAlso: DARZALEXDaratumumab will be administered intravenously. | Drug | FT836 CAR T cells (1 x 10^8 cells per dose), FT836 CAR T cells (3 x 108 cells per dose), FT836 CAR T cells (up to 9 x 108 cells per dose) |
Primary outcome
Incidence of Grade 3 or higher adverse events
Time frame: start of therapy through 30 days after the end of study therapy, up to 2 years
This measure is the number of Grade 3 or higher adverse events possibly, probably, or definitely related to the study therapy. Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded and assessed using the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading systems. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) will be graded and assessed using the ASTCT panel guidelines.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Binod Dhakal, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT836 CAR T cells (1 x 10^8 cells per dose), FT836 CAR T cells (3 x 108 cells per dose) and FT836 CAR T cells (up to 9 x 108 cells per dose) in people with Relapse Multiple Myeloma and Refractory 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 26 inclusion and 19 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 4 Nov 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?
Incidence of Grade 3 or higher adverse events (time frame: start of therapy through 30 days after the end of study therapy, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.