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CAR T-cell Therapy

CART Therapy for Multiple Myeloma

Phase 1

Waitlist Available

Led By Alfred Garfall, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Subjects must be ≥ 18 years of age

High-risk FISH features in conjunction with Beta-2-microglobulin ≥ 5.5 mg/L

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment regimen that is based on an established safe treatment. The new regimen is being tested for safety and how well it works in patients with multiple myeloma who are responding to first- or second-line therapy.

Who is the study for?

This trial is for adults with high-risk multiple myeloma who have started treatment within the last year and seen some improvement but not a complete cure. They shouldn't have had stem cell transplants or certain chemotherapies, and their vital organs must be functioning well. Participants need to agree to birth control methods if applicable.Check my eligibility

What is being tested?

The study tests a single-dose infusion of CART-BCMA alone or combined with huCART19 in patients after initial therapy success. It explores different chemotherapy regimens, combination treatments, and dosing strategies to improve outcomes for those at high risk.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, headache, nausea; organ inflammation; blood count changes; increased risk of infections due to immune suppression from lymphodepleting chemotherapy.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My test shows high-risk genetic features and high Beta-2-microglobulin levels.

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My blood has more than 20% plasma cells.

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My cancer worsened quickly after starting my first treatment.

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I meet the specific requirements for previous myeloma treatments.

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I have not had a stem cell transplant.

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My treatment for multiple myeloma has shown some positive response.

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Side effects from my previous treatments have mostly gone away.

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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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My initial cancer treatment did not work as expected.

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I have not had chemotherapy that kills cancer cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Adverse event reporting

Cytokine

Cellular composition of CAR T cell products

+13 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase CExperimental Treatment1 Intervention

Single-dose infusion phase to test the safety of single-dose infusion of CART-BCMA alone (Cohort 1) and CART-BCMA + huCART19 (Cohort 2) as single-dose infusions after lymphodepleting chemotherapy with cyclophosphamide + fludarabine in patients responding to first- or second-line therapy.

Group II: Phase BExperimental Treatment1 Intervention

Randomization Phase in which patients responding to first or second-line therapy will receive either CART-BCMA alone (Cohort 1) or CART-BCMA + huCART19 (Cohort 2) as split-doses after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.

Group III: Phase A ExpansionExperimental Treatment1 Intervention

Once safety of CART-BCMA/huCART19 combination therapy is established in Phase A, an expansion of Phase A will occur in which the Phase A target population (patients with relapsed/refractory multiple myeloma responding to a standard salvage therapy regimen) will receive both CART-BCMA and huCART19. Enrollment into the Phase A Expansion may occur concurrently with Phase B once opened.

Group IV: Phase AExperimental Treatment1 Intervention

Safety Run-in to test the safety of CART-BCMA + huCART19 as split-dose infusions after lymphodepleting chemotherapy with cyclophosphamide + fludarabine in patients who have relapsed/refractory myeloma after two prior regimens but who are responding to their current therapy.

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,048 Total Patients Enrolled

13 Trials studying Multiple Myeloma

339 Patients Enrolled for Multiple Myeloma

NovartisIndustry Sponsor

1,610 Previous Clinical Trials

2,719,230 Total Patients Enrolled

24 Trials studying Multiple Myeloma

5,133 Patients Enrolled for Multiple Myeloma

Alfred Garfall, MDPrincipal InvestigatorUniversity of Pennsylvania

7 Previous Clinical Trials

204 Total Patients Enrolled

6 Trials studying Multiple Myeloma

184 Patients Enrolled for Multiple Myeloma

Media Library

CART-BCMA (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03549442 — Phase 1

Multiple Myeloma Research Study Groups: Phase A, Phase B, Phase C, Phase A Expansion

Multiple Myeloma Clinical Trial 2023: CART-BCMA Highlights & Side Effects. Trial Name: NCT03549442 — Phase 1

CART-BCMA (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03549442 — Phase 1

Frequently Asked Questions

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

Is the one-time infusion of CART BCMA or CART BCMA + huCART19 officially sanctioned by the FDA?

"Our experts at Power have evaluated the safety of Single-dose infusion of CART BCMA or CART BCMA + huCART19 as a 1 due to Phase 1 trial data being limited in terms of both efficacy and security."

Answered by AI

Are there any opportunities currently available to join this research project?

"The clinicaltrials.gov database shows that this particular trial is not currently accepting patients, despite being initially posted on May 9th 2018 and last updated on July 11th 2022. Fortunately, there are 807 other trials actively recruiting now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Up-front CART-BCMA With or Without huCART19 in High-risk Multiple Myeloma

2018. "Up-front CART-BCMA With or Without huCART19 in High-risk Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03549442.

All > Multiple Myeloma