FT836 CAR T-cell + Daratumumab for Multiple Myeloma

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Medical College of Wisconsin

Must be taking: Proteasome inhibitors, Immunomodulators

Must not be taking: Investigational agents, Cytotoxic chemotherapy

Disqualifiers: HIV, Hepatitis B/C, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment for individuals with multiple myeloma, a type of blood cancer, who haven't found success with previous treatments. The study aims to determine if FT836, a CAR T-cell therapy, used with the drug daratumumab, is safe and potentially effective. Participants should have undergone at least three different treatments, including specific drugs for multiple myeloma. This trial offers a new treatment option when other methods have failed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, giving participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot use investigational drugs or certain treatments like cytotoxic chemotherapy within 14 days of starting daratumumab. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that FT836 CAR T-cell therapy, the treatment under study, is still in the early testing stages to assess its safety. Limited information exists on how well people tolerate it. However, CAR T-cell therapies have shown promise in studies for other cancers, prompting their testing for multiple myeloma.

Similar treatments often cause side effects such as fever, tiredness, and low blood cell counts, which doctors monitor closely during trials. As a phase 1 trial, the primary goal is to determine a safe dose and observe any side effects. This trial aims to learn more about the safety of FT836 when used with daratumumab, another cancer treatment.

FT836 has shown positive results in lab tests and animal studies, but more research in humans is needed to fully understand its safety. Participants in this trial will be closely monitored to ensure their safety as researchers gather more information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about FT836 CAR T-cell therapy for multiple myeloma because it represents a novel approach compared to existing treatments like proteasome inhibitors and immunomodulatory drugs. Unlike traditional therapies, FT836 uses genetically engineered T-cells to specifically target and destroy cancer cells, offering a potentially more precise attack on the disease. This CAR T-cell therapy is combined with Daratumumab, a monoclonal antibody, to enhance its effectiveness by also targeting a different protein on the cancer cells. This dual-action approach could lead to more durable responses and improved outcomes for patients with multiple myeloma.

What evidence suggests that FT836 CAR T-cell + Daratumumab could be an effective treatment for multiple myeloma?

Research has shown that CAR T-cell therapies hold great promise for treating multiple myeloma, a type of blood cancer. In previous studies, 96.4% of patients achieved minimal residual disease (MRD) negativity, with no detectable cancer cells after treatment. Additionally, 80.4% of these patients experienced a complete response, meaning all signs of cancer disappeared. This trial will explore different dosages of FT836 CAR T-cells, which could prove highly effective based on early results from similar treatments. While researchers continue to study FT836, these encouraging outcomes from other CAR T-cell therapies suggest potential benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Binod Dhakal, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma that has come back or didn't respond to previous treatments. Specific details about who can join are not provided, but typically participants must meet certain health standards and have failed other therapies.

Inclusion Criteria

Patients must have measurable disease as defined by specific criteria

Patients must be able to provide written informed consent

Expected survival must be greater than 12 weeks

Exclusion Criteria

Positive beta-Human Chorionic Gonadotropin (HCG) in females of child-bearing potential

Concurrent use of investigational therapeutic agents or enrollment in another therapeutic clinical trial

I haven't needed treatment for another cancer in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive FT836 CAR T-cell therapy in combination with daratumumab to evaluate safety and preliminary efficacy

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daratumumab
• FT836

Trial Overview The study is testing different doses of FT836 CAR T cells combined with a set dose of Daratumumab in patients. It's an early-phase trial to check safety and initial results of this combination therapy on relapsed/refractory multiple myeloma.

How Is the Trial Designed?

Group I: FT836 CAR T cells (up to 9 x 108 cells per dose) Experimental Treatment 2 Interventions

This is Dose Level 2, which is ≤3 times Dose Level 1.

Group II: FT836 CAR T cells (3 x 108 cells per dose) Experimental Treatment 2 Interventions

This is Dose Level 1 (starting dose).

Group III: FT836 CAR T cells (1 x 10^8 cells per dose) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7399644/

CAR T-Cells in Multiple Myeloma: State of the Art and Future ... Regarding efficacy results, the ORR was 73% with 33% of patients achieving ... γ-secretase inhibition increases efficacy of BCMA-specific chimeric antigen ...

2. dana-farber.org dana-farber.org/for-physicians/clinical-resources/hematologic-malignancies/advances-newsletter/2025-issue-20/multiple-myeloma-cart-t-cell-therapy-update

An Update on CAR T-Cell Therapy in Multiple Myeloma We are evaluating strategies to improve the CAR T-cell product to enhance efficacy and safety, study novel antigens, and use these therapies in ...

3. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-025-06543-x

Key predictors of long-term outcomes in BCMA-targeted CAR ... Among the patients, 96.4% (54 of 56) achieved minimal residual disease (MRD) negativity, whereas 80.4% (45 of 56) achieved complete response (CR) ...

4. cancernetwork.com cancernetwork.com/view/novel-car-t-cell-therapies-may-improve-outcomes-vs-socs-in-multiple-myeloma

Novel CAR T-Cell Therapies May Improve Outcomes Vs ... CAR T-cell therapies have shown a lot of promise in the treatment of multiple myeloma, and at the 2025 National Immune Cell Effector Therapy ...

5. hematology.org hematology.org/newsroom/press-releases/2024/cilta-cel-found-highly-effective-in-first-real-world-study

Cilta-cel Found Highly Effective in First Real-World Study Of 236 patients who received cilta-cel infusions at 16 US medical centers in 2022, 89% saw their cancer respond to the treatment and 70% had a complete ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07221032

Study Details | NCT07221032 | FT836 CAR T-cell Therapy ... This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary ...

7. synapse.patsnap.com synapse.patsnap.com/drug/ec5218bd4dd74f479c6b53f7ca29cd39

FT-836 - Drug Targets, Indications, Patents A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With ...

8. biospace.com biospace.com/press-releases/fate-therapeutics-presents-pan-tumor-targeting-preclinical-data-for-ft836-mica-b-targeted-car-t-cell-product-candidate-at-2024-sitc-annual-meeting

Fate Therapeutics Presents Pan-tumor Targeting ... “Our FT836 preclinical data presented today at SITC support the pan-cancer activity of MICA/B targeting, and indicate that our next-generation, ...

9. ir.fatetherapeutics.com ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-highlights-ipsc-derived-shelf-car-nk-cell

Fate Therapeutics Highlights iPSC-derived, Off-the-shelf CAR ... FT576 was effective at controlling tumor growth in vivo, with deeper and more sustained anti-tumor activity observed through multi-dose administration.

10. linkedin.com linkedin.com/posts/zeynep-birsu-cincin_multiplemyeloma-car-ft836-activity-7388714736848109568-mxEn

FT836 + Daratumumab Phase 1 trial for RRMM patients Next-gen CAR T-cell meets CD38: FT836 + Daratumumab enters Phase 1 in relapsed/refractory multiple myeloma A new investigator-initiated ...