237 Participants Needed

CAR-T Therapy for Multiple Myeloma

(CARTITUDE-2 Trial)

Recruiting at 48 trial locations
SC
SP
Overseen BySparkCures Patient Support (US only)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.678910

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.457811

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.
See 10 more

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.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-68284528
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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: JNJ-68284528Experimental Treatment5 Interventions

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

🇺🇸
Approved in United States as Carvykti for:
🇪🇺
Approved in European Union as Carvykti for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

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.
Cilta-cel OK'd for Multiple Myeloma.[2022]
In a study of 203 patients with multiple myeloma, those previously treated with BCMA-targeted therapies had lower response rates and shorter durations of response when treated with idecabtagene vicleucel (ide-cel) compared to those without prior BCMA treatment.
Despite the lower efficacy in patients with prior BCMA therapy, ide-cel still produced meaningful clinical responses, particularly in patients who had received anti-BCMA CAR T therapy, indicating that sequential BCMA-targeted treatments can still be beneficial.
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]
The study developed dual-split CAR T cells targeting CD38 and CD138, which effectively killed multiple myeloma cells while sparing healthy cells, demonstrating a promising approach for enhancing specificity in CAR T-cell therapy.
The optimal combination of a low-affinity CD138sCAR and a high-affinity CD38cCAR showed effective anti-multiple myeloma activity in vivo, even against cells from patients previously treated with daratumumab, indicating potential for broader application in resistant cases.
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]

Citations

Cilta-cel OK'd for Multiple Myeloma. [2022]
Real-world experience of patients with multiple myeloma receiving ide-cel after a prior BCMA-targeted therapy. [2023]
Specific Targeting of Multiple Myeloma by Dual Split-signaling Chimeric Antigen Receptor T cells Directed against CD38 and CD138. [2023]
Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma. [2023]
Ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma: CARTITUDE-1 (phase 2) Japanese cohort. [2022]
Ciltacabtagene autoleucel for the treatment of multiple myeloma. [2023]
Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study. [2023]
Ciltacabtagene autoleucel: The second anti-BCMA CAR T-cell therapeutic armamentarium of relapsed or refractory multiple myeloma. [2022]
Chimeric antigen receptor T cell therapy for multiple myeloma. [2020]
Current advances in chimeric antigen receptor T-cell therapy for refractory/relapsed multiple myeloma. [2020]
Chimeric antigen receptor T cell therapies for multiple myeloma. [2020]
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