FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma

NCT07221032 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IIT-DHAKAL-FT836-DARA
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapse Multiple Myeloma; Refractory Multiple Myeloma

Keywords

multiple myeloma; CAR-T therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  start of therapy through 30 days after the end of study therapy, up to 2 years

Study Arms (3)

FT836 CAR T cells (1 x 10^8 cells per dose)

EXPERIMENTAL

This is Dose Level 0 (de-escalation dose).

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).

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.

Biological: FT836 CAR T cells (up to 9 x 108 cells per dose); Drug: Daratumumab 16 mg/kg

Interventions

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 (1 x 10^8 cells per dose)

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 (3 x 108 cells per dose)

FT836 CAR T cells (up to 9 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)

Daratumumab 16 mg/kg DRUG

Daratumumab will be administered intravenously.

Also known as: DARZALEX

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)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.
• Patients with active Central Nervous System (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture.
• a. 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

daratumumab

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

Study Officials

• Binod Dhakal, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 27, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)