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CAR T-cell Therapy

CAR-T Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial studies a new type of cancer therapy to treat relapsed and refractory multiple myeloma. It investigates the safety and effectiveness of the therapy.

Who is the study for?

Adults over 18 with multiple myeloma that's come back or hasn't responded after at least three treatments, including specific drugs like IMiDs and proteasome inhibitors. They must have measurable disease, be in good physical condition (ECOG 0-1), and have cells ready for making the CAR-T therapy. Not eligible if they've had certain other myeloma treatments, recent bone marrow transplants, plasma cell leukemia, CNS involvement by cancer, autoimmune neurological conditions, or poor organ function.Check my eligibility

What is being tested?

The trial is testing PHE885 CAR-T therapy on adults with relapsed/refractory multiple myeloma. It's a Phase II study to see how well it works and its safety when made using a new process. Participants will receive this single-agent treatment to evaluate its effectiveness against their cancer.See study design

What are the potential side effects?

Potential side effects of PHE885 may include immune system reactions leading to symptoms in various organs (like fever or fatigue), infusion-related reactions where the therapy is given into the vein, blood count changes increasing infection risk; exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukapheresis material is approved for use.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 years old or older.

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I've had 3+ treatments for my condition, including specific drugs, and my disease is still getting worse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Heart rate

Secondary outcome measures

Cellular kinetics parameter: AUC

Cellular kinetics parameter: Cmax

Cellular kinetics parameter: Tmax

+15 more

Other outcome measures

Key Measure

Trial Design

1Treatment groups

Experimental Treatment

Group I: PHE885Experimental Treatment1 Intervention

Patients will receive PHE885

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,857 Previous Clinical Trials

4,197,671 Total Patients Enrolled

38 Trials studying Multiple Myeloma

2,366 Patients Enrolled for Multiple Myeloma

Media Library

PHE885 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05172596 — Phase 2

Multiple Myeloma Research Study Groups: PHE885

Multiple Myeloma Clinical Trial 2023: PHE885 Highlights & Side Effects. Trial Name: NCT05172596 — Phase 2

PHE885 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05172596 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being sought at this time for the clinical trial?

"The clinical trial is currently seeking volunteers, as indicated on the official website. The listing was originally posted in March of 2022 and updated last month (February 2023)."

Answered by AI

What have been the results of assessments on PHE885's safety to patients?

"In light of the fact this is still a Phase 2 trial with limited data, our team has assigned PHE885 an assessment score of two; indicating that safety is supported to some degree but efficacy remains unproven."

Answered by AI

What is the total number of participants in this experiment?

"Indeed, the clinical trial is indeed recruiting patients. According to its description on clinicaltrials.gov, which was originally published on March 7th 2022 and recently modified February 15th 2023, it aims to recruit 136 participants from two distinct health facilities."

Answered by AI

What is the purpose of this experimental process?

"The primary goal of the trial, which will span two years, is to gauge overall response rate (ORR) as determined by an Independent Review Committee. Secondary objectives include measuring durability of minimal residual disease negativity, transgene PHE885 concentrations in peripheral blood and bone marrow over time via quantitative polymerase chain reaction testing and complete response rate according to International Myeloma Working Group criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma

2022. "PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05172596.