FT576 for Multiple Myeloma

Recruiting at 17 trial locations

Overseen By Fate Trial Disclosure

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Fate Therapeutics

Must not be taking: Immunosuppressants, Antiepileptics

Disqualifiers: Cardiovascular disease, CNS disease, Infections, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called FT576 alone and with an existing drug, daratumumab, in patients with multiple myeloma. Multiple myeloma is a cancer of plasma cells in the bone marrow. FT576 aims to kill cancer cells directly, while daratumumab helps the immune system to destroy these cells. Daratumumab has shown effectiveness in treating multiple myeloma, both alone and in combination with other drugs.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, there are washout periods (time without taking certain medications) for some therapies, like chemotherapy and biologic therapy, before starting the trial treatment.

What data supports the effectiveness of the drug FT576 for treating multiple myeloma?

Daratumumab, a component of the treatment, has shown effectiveness in treating multiple myeloma by inducing a response in about one-third of patients and prolonging progression-free survival when used in combination with other drugs. It has been well-tolerated and is considered a valuable addition to treatment options for relapsed or refractory multiple myeloma. ^{1 2 3 4 5}

Is daratumumab generally safe for humans?

Daratumumab, used for treating multiple myeloma, has been shown to have a generally acceptable safety profile. Common side effects include low blood cell counts (neutropenia, thrombocytopenia, anemia) and infusion-related reactions, which are mostly mild to moderate in severity. ^{1 2 3 4 6}

What makes the drug FT576 for multiple myeloma unique?

FT576, which includes daratumumab, is unique because it targets CD38, a protein found on multiple myeloma cells, and can be administered subcutaneously (under the skin) as well as intravenously (through a vein). This flexibility in administration and its ability to work in combination with other drugs make it a novel option for treating multiple myeloma. ^{1 2 3 4 6}

Research Team

Fate Trial Disclosure

Principal Investigator

Fate Therapeutics, Inc

Eligibility Criteria

This trial is for adults with relapsed or refractory Multiple Myeloma who have tried at least two or three prior therapies, depending on the regimen. They should not be severely ill (ECOG PS <2), have significant infections like HIV/HBV/HCV, recent live vaccines, organ transplants, other cancers within 2 years (with exceptions), and must meet certain blood and organ function criteria.

Inclusion Criteria

I have previously received BCMA CAR T-cell therapy or BCMA-targeted treatments.

I have relapsed or refractory multiple myeloma with measurable indicators.

My multiple myeloma has worsened after 3 treatments including IMiD, proteasome inhibitor, and anti-CD38.

Exclusion Criteria

Your white blood cell count is too low without growth factor support, or your platelet count is too low without a recent platelet transfusion.

I haven't had any cancer other than my current one in the last 2 years.

I haven't had certain cancer treatments recently before starting the FT576 trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive escalating doses of FT576 as monotherapy or in combination with daratumumab to determine the optimal dose

Varies

Expansion

Participants receive the determined optimal dose of FT576 as monotherapy or in combination with daratumumab to further evaluate safety and efficacy

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Long-term follow-up

Participants are monitored for long-term outcomes such as progression-free survival and overall survival

Up to 15 years

Treatment Details

Interventions

• Cyclophosphamide
• Daratumumab
• Fludarabine
• FT576

Trial Overview The study tests FT576 alone and with daratumumab in different doses to find the safest and most effective amount for treating Multiple Myeloma. It's a Phase I trial that starts by increasing doses (dose-escalation) then gives it to more people at the best dose found (expansion stage).

Participant Groups

Group I: Regimens B-B4 Experimental Treatment 5 Interventions

FT576 single dose in combination with daratumumab in subjects with r/r MM

Group II: Regimens A-A4 Experimental Treatment 4 Interventions

FT576 single dose monotherapy in subjects with r/r MM

Group III: Regimen B1 Experimental Treatment 5 Interventions

FT576 multiple dose in combination with daratumumab in subjects with r/r MM

Group IV: Regimen A1 Experimental Treatment 4 Interventions

FT576 multiple dose monotherapy in subjects with r/r MM

Daratumumab is already approved in European Union, United States for the following indications:

Approved in European Union as Darzalex for:

• Relapsed and refractory multiple myeloma
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

Approved in United States as Darzalex for:

• Multiple myeloma in patients who have received at least three prior therapies
• Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
• Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone

Who Is Running the Clinical Trial?

Fate Therapeutics

Lead Sponsor

Trials

22

Recruited

1,200+

Findings from Research

Daratumumab, a monoclonal antibody targeting CD38, has been approved in the USA for treating multiple myeloma in patients who have undergone at least three prior therapies, demonstrating its role as a treatment option for difficult-to-treat cases.

In a phase II trial, daratumumab monotherapy showed an overall response rate of about 30% in patients with relapsed or refractory multiple myeloma, indicating its efficacy in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: First Global Approval. McKeage, K.[2018]

Daratumumab, a monoclonal antibody targeting CD38, has shown significant efficacy as a monotherapy in relapsed/refractory multiple myeloma, achieving an overall response in about one-third of patients, with rapid and durable effects.

In combination with other treatments like bortezomib or lenalidomide, daratumumab significantly prolonged progression-free survival, although the overall survival benefit is still being evaluated, and it was generally well tolerated with manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. Blair, HA.[2018]

Daratumumab is a monoclonal antibody that effectively targets CD38 on multiple myeloma cells, leading to cell death through various mechanisms such as complement-dependent cytotoxicity and antibody-dependent cell-mediated cytotoxicity.

It has shown a favorable safety profile and significant clinical activity as both a standalone treatment and in combination with lenalidomide for patients with relapsed multiple myeloma who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: monoclonal antibody therapy to treat multiple myeloma. Xia, C., Ribeiro, M., Scott, S., et al.[2018]

Intravenous daratumumab, when combined with bortezomib, thalidomide, and dexamethasone, significantly improves treatment outcomes for adults with newly diagnosed multiple myeloma, leading to higher rates of stringent complete response and prolonged progression-free survival, as shown in the phase III CASSIOPEIA trial.

The addition of daratumumab has a minimal impact on overall toxicity, with the most common serious side effects being blood-related issues, indicating it is a relatively safe option for patients undergoing treatment for multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daratumumab: A Review in Combination Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma. Lamb, YN.[2021]

Daratumumab received conditional marketing authorization in the EU for treating relapsed and refractory multiple myeloma, showing an overall response rate of 29.2% in heavily pre-treated patients, indicating its efficacy as a monotherapy.

The drug was later approved for use in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, demonstrating improved progression-free survival in patients who had received at least one prior therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma. Tzogani, K., Penninga, E., Schougaard Christiansen, ML., et al.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Daratumumab: First Global Approval. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma. [2018]

3. Spain pubmed.ncbi.nlm.nih.gov

Daratumumab: monoclonal antibody therapy to treat multiple myeloma. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Daratumumab: A Review in Combination Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Practical Considerations for the Use of Daratumumab, a Novel CD38 Monoclonal Antibody, in Myeloma. [2018]

6. England pubmed.ncbi.nlm.nih.gov

EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple Myeloma. [2020]