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CAR T-cell Therapy

CAR-T Cell Therapy for Multiple Myeloma

Phase 1
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
Adequate hematological values
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving genetically engineering a patient's own T cells to better attack their tumor. So far it is showing to be feasible and safe with preliminary signs of efficacy.

Who is the study for?
This trial is for adults with Multiple Myeloma who've had at least two prior treatments, including specific drugs like IMiDs and proteasome inhibitors. They should have a performance status of 0 or 1 if previously treated, or up to 2 if newly diagnosed after standard therapy. Participants must not have had any genetic cell therapies before, nor certain cancer treatments close to joining the study.Check my eligibility
What is being tested?
The trial tests PHE885, a new type of CAR-T cell therapy targeting BCMA on myeloma cells. It's a first-in-human study assessing how safe it is and its initial effectiveness against multiple myeloma as a single agent treatment.See study design
What are the potential side effects?
As this is an early-phase trial for CAR-T therapy, potential side effects may include immune system reactions, infusion-related symptoms, changes in blood counts leading to increased infection risk or bleeding tendencies, fatigue and possible organ inflammation.

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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My blood test results are within normal ranges.
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I can take care of myself and am up and about more than half of my waking hours.
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I have MM, failed at least 2 treatments including specific drugs, and my disease is getting worse.
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I have multiple myeloma, treated with specific therapies, and have seen improvement.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 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
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence of Dose limiting toxicities (DLT)
Nature of Dose limiting toxicities (DLT)
Secondary outcome measures
AUC of BCMA CAR-T cells
CRR at months 3 and 6 in Part A
CRR at months 3 and 6 in Part B
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: PHE885 (Part B)Experimental Treatment1 Intervention
Newly diagnosed multiple myeloma (NDMM) patients will receive PHE885.
Group II: PHE885 (Part A)Experimental Treatment1 Intervention
Relapsed and/or refractory multiple myeloma (r/r MM) patients will receive PHE885.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,850 Previous Clinical Trials
4,194,862 Total Patients Enrolled
38 Trials studying Multiple Myeloma
2,406 Patients Enrolled for Multiple Myeloma

Media Library

PHE885 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04318327 — Phase 1
Multiple Myeloma Research Study Groups: PHE885 (Part A), PHE885 (Part B)
Multiple Myeloma Clinical Trial 2023: PHE885 Highlights & Side Effects. Trial Name: NCT04318327 — Phase 1
PHE885 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04318327 — Phase 1

Frequently Asked Questions

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

What is the maximum number of participants for this clinical trial?

"This clinical trial requires 56 patients that meet the predetermined eligibility requirements. Those interested can enroll from a range of healthcare facilities, such as Medical College of Wisconsin in Milwaukee, WI and Beth Israel Deaconess Medical Centre KS121 in Boston, MA."

Answered by AI

Are participants still being welcomed for this experiment?

"As indicated on clinicaltrials.gov, this medical study is currently seeking volunteers and has been open since July 23rd 2020 with the last update made on July 28th 2022."

Answered by AI

Does PHE885 come with any significant safety risks?

"The safety of PHE885 is estimated at a level 1 on the scale due to its Phase 1 classification, indicating that there is minimal supporting evidence for both efficacy and safety."

Answered by AI
~32 spots leftby Feb 2026