CAR-T Therapy for Multiple Myeloma

(CARTITUDE-2 Trial)

Recruiting in Palo Alto (17 mi)

+48 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Janssen Research & Development, LLC

Must not be taking: Corticosteroids, BCMA-targeted, CAR-T

Disqualifiers: Active infections, Autoimmune, CNS involvement, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment called JNJ-68284528. It aims to help patients who still have small amounts of cancer cells after their initial treatment. The treatment works by finding and killing these leftover cancer cells to prevent the disease from coming back.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less, which might imply adjustments to your current treatment. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Carvykti (cilta-cel) for multiple myeloma?

In a study, Carvykti (cilta-cel) showed a 100% overall response rate in patients with relapsed or refractory multiple myeloma, with 87.5% achieving a very good partial response or better. This suggests that the treatment is highly effective for this condition. ^{1 2 3 4 5}

Is CAR-T therapy (cilta-cel) safe for humans?

Cilta-cel, a CAR-T therapy for multiple myeloma, has shown a generally tolerable safety profile, with most side effects being manageable. Common side effects include cytokine release syndrome (a reaction that can cause fever and low blood pressure) and other adverse events, but serious neurotoxicity was not reported in the studies. ^{1 5 6 7 8}

How is the treatment JNJ-68284528 (Carvykti) different from other treatments for multiple myeloma?

JNJ-68284528 (Carvykti) is a unique treatment for multiple myeloma because it uses CAR-T cell therapy, where a patient's own T cells are modified to target and kill cancer cells. This approach is different from traditional treatments like chemotherapy or stem cell transplants, as it specifically targets the B cell maturation antigen (BCMA) on myeloma cells, offering a promising option for patients with relapsed or refractory multiple myeloma. ^{3 4 9 10 11}

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for multiple myeloma patients with varying treatment histories. Some must have tried specific therapies and be refractory to lenalidomide, while others may be newly diagnosed or ineligible for certain treatments due to age or comorbidities. Participants need a measurable level of disease and should be in good physical condition (ECOG grade 0-1).

Inclusion Criteria

I've had 1-3 treatments for my condition, including specific therapies, and one didn't work as expected.

I have newly diagnosed multiple myeloma and have undergone 4 to 8 cycles of initial treatment.

I am not a candidate for high-dose chemotherapy with stem cell transplant due to age, health issues, or personal choice.

Exclusion Criteria

My multiple myeloma has affected or previously affected my brain or spinal cord.

You have a serious medical condition such as active infection needing strong antibiotics, uncontrolled fungal infection, active autoimmune disease, recent history of autoimmune disease, dementia, Parkinson's disease, or other brain disorders.

I have no active cancers except for certain treated or low-risk cases.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepletion

Participants undergo lymphodepletion prior to receiving JNJ-68284528 infusion

1 week

Treatment

Participants receive a single infusion of JNJ-68284528, with some cohorts receiving additional treatments such as lenalidomide

1 day for infusion, followed by monitoring

Follow-up

Participants are monitored for safety, effectiveness, and MRD status after treatment

Up to 2 years and 6 months

Open-label extension (optional)

Participants may continue to be monitored or receive additional treatment based on their response and MRD status

Long-term

Treatment Details

Interventions

• JNJ-68284528 (CAR T-cell Therapy)

Trial Overview The study tests JNJ-68284528, a CAR-T therapy targeting BCMA, alongside other drugs like dexamethasone, lenalidomide, daratumumab, and bortezomib. It aims to assess the rate at which participants achieve minimal residual disease negativity.

Participant Groups

Group I: JNJ-68284528 Experimental Treatment 5 Interventions

Single group assignment-Post lymphodepletion, JNJ-68284528 single infusion given to Part A participants: Cohort A(Progressive disease post 1-3 prior lines of therapy), Cohort B(Early relapse post front-line), Cohort C(Relapsed/refractory multiple myeloma post PI, IMiD,anti-CD38,anti-BCMA therapy), Cohort D(Less than CR post ASCT front-line therapy, some participants will receive JNJ-68284528 then lenalidomide), Cohort F(Newly diagnosed multiple myeloma \[NDMM\], standard risk \[International Staging System Stage I/II\] and post initial therapy); Cohort E(NDMM,transplant not planned,high risk disease) will first receive quadruplet induction regimen of daratumumab,bortezomib,lenalidomide and dexamethasone(D-VRd) then lymphodepletion and JNJ-68284528 then consolidation regimen of lenalidomide. Part B:Cohort G(NDMM,transplant not planned) will receive daratumumab, lenalidomide and dexamethasone followed by cilta-cel; Cohort H(NDMM,transplant-eligible) will receive D-VRd followed by cilta-cel.

JNJ-68284528 is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Carvykti for:

• Relapsed or refractory multiple myeloma after one or more prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide

🇪🇺 Approved in European Union as Carvykti for:

• Relapsed and refractory multiple myeloma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Kansas Cancer Center Westwood, KS

Norton Cancer Institute Louisville, KY

University of Pennsylvania Philadelphia, PA

Yale University School Of Medicine New Haven, CT

More Trial Locations

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1022

Patients Recruited

6,408,000+

Findings from Research

Ciltacabtagene autoleucel (cilta-cel) has been approved by the FDA as a fifth-line treatment option for patients with relapsed or refractory multiple myeloma, marking a significant advancement in therapy options for this challenging condition.

Cilta-cel is notable for being the second chimeric antigen receptor T-cell therapy targeting BCMA to receive regulatory approval within a year, highlighting the rapid development of innovative treatments in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cilta-cel OK'd for Multiple Myeloma. [2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience of patients with multiple myeloma receiving ide-cel after a prior BCMA-targeted therapy. Ferreri, CJ., Hildebrandt, MAT., Hashmi, H., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specific Targeting of Multiple Myeloma by Dual Split-signaling Chimeric Antigen Receptor T cells Directed against CD38 and CD138. van der Schans, JJ., Wang, Z., van Arkel, J., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma. Minakata, D., Ishida, T., Ando, K., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma: CARTITUDE-1 (phase 2) Japanese cohort. Ri, M., Suzuki, K., Ishida, T., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciltacabtagene autoleucel for the treatment of multiple myeloma. Holstein, SA.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study. Cohen, AD., Hari, P., Htut, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma. Chekol Abebe, E., Yibeltal Shiferaw, M., Tadele Admasu, F., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric antigen receptor T cell therapy for multiple myeloma. Hasegawa, K., Hosen, N.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current advances in chimeric antigen receptor T-cell therapy for refractory/relapsed multiple myeloma. Huang, H., Wu, HW., Hu, YX.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric antigen receptor T cell therapies for multiple myeloma. Wu, C., Zhang, L., Brockman, QR., et al.[2020]

References

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

Cilta-cel OK'd for Multiple Myeloma. [2022]

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

Real-world experience of patients with multiple myeloma receiving ide-cel after a prior BCMA-targeted therapy. [2023]

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

Specific Targeting of Multiple Myeloma by Dual Split-signaling Chimeric Antigen Receptor T cells Directed against CD38 and CD138. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma: CARTITUDE-1 (phase 2) Japanese cohort. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Ciltacabtagene autoleucel for the treatment of multiple myeloma. [2023]

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

Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Chimeric antigen receptor T cell therapy for multiple myeloma. [2020]

10. China pubmed.ncbi.nlm.nih.gov

Current advances in chimeric antigen receptor T-cell therapy for refractory/relapsed multiple myeloma. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Chimeric antigen receptor T cell therapies for multiple myeloma. [2020]