Cell Therapy for Multiple Myeloma

Recruiting at 3 trial locations

Overseen By Arcellx, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kite, A Gilead Company

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new cell therapy for patients with multiple myeloma that has come back or didn't respond to other treatments. The therapy uses specially modified cells to attack the cancer. The study also includes ongoing safety monitoring. This cell therapy has shown promising results in early studies for treating relapsed/refractory multiple myeloma.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ARC-T Plus Anti-BCMA SparX, CART-ddBCMA, anitocabtagene-autoleucel for multiple myeloma?

Research shows that BCMA-targeted CAR T-cell therapies are highly effective in treating multiple myeloma, with high response rates in patients who have relapsed or are resistant to other treatments. These therapies have shown promising results in improving patient outcomes and are considered a powerful option for those who have not responded to standard treatments. ^{1 2 3 4 5}

Is cell therapy for multiple myeloma safe?

Research shows that cell therapy for multiple myeloma, like BCMA-targeted CAR T-cell therapy, is generally safe. Most studies report manageable side effects, such as mild cytokine release syndrome (a reaction that can cause fever and low blood pressure) and low-grade neurologic issues, with no severe cases observed. ^{1 3 6 7 8}

What makes the ARC-T Plus Anti-BCMA SparX, CART-ddBCMA treatment unique for multiple myeloma?

This treatment is unique because it uses a type of cell therapy called CAR T-cell therapy, which is engineered to target a specific protein called BCMA on cancer cells, potentially offering a more precise and potent option for treating multiple myeloma compared to traditional therapies. ^{1 2 3 9 10}

Research Team

Arcellx, Inc.

Principal Investigator

Arcellx, Inc.

Eligibility Criteria

This trial is for people with multiple myeloma who have tried at least three treatments, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. They should not be severely ill with other conditions or have a history of plasma cell leukemia. Participants need to be relatively healthy otherwise and expected to live more than 12 weeks.

Inclusion Criteria

You have a disease that can be measured and documented.

My multiple myeloma has not responded to 3 types of treatments including PI, IMiD, and CD38mab.

My organs are working well.

Exclusion Criteria

I have or had plasma cell leukemia.

I do not have any severe illnesses or lab results that are out of control.

I cannot take fludarabine or cyclophosphamide due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Phase I study of BCMA-specific CAR-modified T-cell therapy for relapsed and refractory multiple myeloma

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Long-term safety follow-up

Includes long-term safety follow-up for participants

Long-term

Treatment Details

Interventions

• ARC-T Plus Anti-BCMA SparX
• CART-ddBCMA

Trial Overview The study is testing new cell therapies called ARC-T Plus Anti-BCMA SparX and CART-ddBCMA in patients whose multiple myeloma has come back or hasn't responded after several treatments. It's an early-stage trial to see if these therapies are safe and how they work.

Participant Groups

Group I: ARM 1 Experimental Treatment 1 Intervention

Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma

Who Is Running the Clinical Trial?

Kite, A Gilead Company

Lead Sponsor

Trials

45

Recruited

4,300+

Arcellx, Inc.

Industry Sponsor

Trials

5

Recruited

650+

Findings from Research

B-cell maturation antigen (BCMA) CAR T cells are emerging as a highly effective treatment for multiple myeloma, showing promise for inclusion in first-line therapy based on clinical and preclinical data.

Advancements in patient stratification through genomic analysis and improvements in CAR T-cell manufacturing are enhancing early diagnosis, management of side effects, and overall access to this innovative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAR T-Cell Therapy in Multiple Myeloma: Mission Accomplished? Rasche, L., Hudecek, M., Einsele, H.[2023]

In a phase II trial involving 69 patients with relapsed or refractory multiple myeloma, the combination of anti-BCMA and anti-CD19 CAR T cells resulted in a high overall response rate of 92%, with 60% achieving a complete response.

The treatment demonstrated a median progression-free survival of 18.3 months and a manageable safety profile, although 95% of patients experienced cytokine release syndrome, indicating the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up of Combination of B-Cell Maturation Antigen and CD19 Chimeric Antigen Receptor T Cells in Multiple Myeloma. Wang, Y., Cao, J., Gu, W., et al.[2022]

In a phase I clinical trial involving 30 multiple myeloma patients, anti-BCMA CAR T cells showed favorable safety with no high-grade cytokine release syndrome and only one case of low-grade neurologic toxicity.

The treatment demonstrated significant efficacy, with 10 out of 15 patients with measurable disease achieving a partial response or better, and 4 patients converting to minimal residual disease-negative complete response, indicating strong antimyeloma activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-BCMA/CD19 CAR T Cells with Early Immunomodulatory Maintenance for Multiple Myeloma Responding to Initial or Later-Line Therapy. Garfall, AL., Cohen, AD., Susanibar-Adaniya, SP., et al.[2023]

The introduction of second-generation proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies has significantly improved survival rates for multiple myeloma patients, but many still relapse, highlighting the need for new therapies.

B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy shows promise as a new treatment option for patients with multiple myeloma who are resistant to current standard therapies, offering a different mechanism of action to combat the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAR T-Cells in Multiple Myeloma Are Ready for Prime Time. Rodríguez-Otero, P., Prósper, F., Alfonso, A., et al.[2023]

BCMA-directed therapies, such as antibody-drug conjugates and CAR T cells, have shown significant effectiveness in treating late-stage myeloma patients who have previously undergone various treatments, but the best order for using these therapies is still unclear.

After anti-BCMA therapy, there are several promising treatment options available, including alternative BCMA therapies and non-BCMA therapies, but more research is needed to personalize treatment strategies based on individual patient factors and disease characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Options at the time of relapse after anti-BCMA therapy. Razzo, B., Garfall, AL., Cohen, AD.[2023]

In a study involving 35 patients with relapsed or refractory multiple myeloma, the CAR T-cell therapy ARI0002h achieved a remarkable overall response rate of 100% within the first 100 days, with 80% of patients showing a very good partial response or better.

The treatment demonstrated a favorable safety profile, with 80% of patients experiencing only mild cytokine-release syndrome (grade 1-2) and no neurotoxic events reported, suggesting that ARI0002h could be a safe and effective option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated initial infusion and booster dose of ARI0002h, a humanised, BCMA-directed CAR T-cell therapy, for patients with relapsed or refractory multiple myeloma (CARTBCMA-HCB-01): a single-arm, multicentre, academic pilot study. Oliver-Caldés, A., González-Calle, V., Cabañas, V., et al.[2023]

BCMA CAR T-cell therapy has shown impressive response rates of 60% to 100% in patients with relapsed/refractory myeloma, indicating its potential as a highly effective treatment option.

While the therapy can lead to severe but reversible toxicities like cytokine release syndrome and neurotoxicity, ongoing studies aim to enhance its safety and efficacy through combinations with other treatments and gene editing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CAR T Cells and Other Cellular Therapies for Multiple Myeloma: 2018 Update. Cohen, AD.[2019]

Chimeric antigen receptor T cells targeting the BCMA protein show promise as a potent treatment for multiple myeloma, based on preliminary results from an ongoing phase I clinical trial in China.

The therapy was well tolerated by patients and led to complete and durable responses in those with relapsed or refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sending CAR T Cells After Multiple Myeloma. [2018]

In a phase 1 study of 33 patients with relapsed or refractory multiple myeloma, the CAR T-cell therapy bb2121 demonstrated a high objective response rate of 85%, with 45% of patients achieving complete responses.

While bb2121 showed promising antitumor activity, it also had significant safety concerns, with 76% of patients experiencing cytokine release syndrome and 42% experiencing neurological toxic effects, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. Raje, N., Berdeja, J., Lin, Y., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

CAR T-Cell Therapy in Multiple Myeloma: Mission Accomplished? [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Long-Term Follow-Up of Combination of B-Cell Maturation Antigen and CD19 Chimeric Antigen Receptor T Cells in Multiple Myeloma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Anti-BCMA/CD19 CAR T Cells with Early Immunomodulatory Maintenance for Multiple Myeloma Responding to Initial or Later-Line Therapy. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

CAR T-Cells in Multiple Myeloma Are Ready for Prime Time. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Options at the time of relapse after anti-BCMA therapy. [2023]

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

Fractionated initial infusion and booster dose of ARI0002h, a humanised, BCMA-directed CAR T-cell therapy, for patients with relapsed or refractory multiple myeloma (CARTBCMA-HCB-01): a single-arm, multicentre, academic pilot study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

CAR T Cells and Other Cellular Therapies for Multiple Myeloma: 2018 Update. [2019]

8. England pubmed.ncbi.nlm.nih.gov

CAR T cell therapy in multiple myeloma, where are we now and where are we heading for? [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Sending CAR T Cells After Multiple Myeloma. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Anti-BCMA CAR T-Cell Therapy bb2121 in Relapsed or Refractory Multiple Myeloma. [2021]