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CAR T-cell Therapy

BCMA CAR-T Cell Therapy for Multiple Myeloma

Phase 1

Waitlist Available

Led By James N Kochenderfer, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

A specific quantitative level of BCMA expression for eligibility is not specified, but patients with multiple myeloma cells that are negative for BCMA by flow cytometry and immunohistochemistry on either bone marrow biopsy or plasmacytoma biopsy will not be enrolled.

- A biopsy-proven plasmacytoma at least 2.0 cm in largest dimension.

Must not have

Patients that require urgent therapy due to tumor mass effects or spinal cord compression.

Patients with active autoimmune skin diseases such as psoriasis or other active autoimmune diseases such as rheumatoid arthritis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each arm/group respectively.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether it is safe to give changed T cells to people with multiple myeloma.

Who is the study for?

Adults aged 18-73 with multiple myeloma resistant to standard treatments, who have tried at least three different therapies including IMiDs and proteasome inhibitors. Participants must not be HIV or hepatitis positive, should have adequate organ function, and agree to use birth control. Those with certain other health conditions or treatments are excluded.

What is being tested?

The trial is testing a gene therapy using the patient's own T cells that are modified in the lab to target cancer cells more effectively. It includes chemotherapy drugs Cyclophosphamide and Fludarabine followed by infusion of these engineered T cells.

What are the potential side effects?

Potential side effects may include reactions from the chemotherapy such as nausea, hair loss, blood disorders; immune responses due to modified T cells like fever or fatigue; and risks associated with infusions such as infection at the site.

Eligibility Criteria

Inclusion Criteria

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

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My multiple myeloma cells show some level of BCMA.

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I have a biopsy-proven plasmacytoma that is at least 2.0 cm big.

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I am between 18 and 73 years old.

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My hepatitis B test results are negative.

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I have tested negative for Hepatitis C.

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My cancer cells show BCMA presence, confirmed by tests on bone marrow or a tumor biopsy.

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I have undergone 3 different treatments for multiple myeloma.

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I have been treated with drugs like lenalidomide and a proteasome inhibitor before.

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My white blood cell count is healthy without needing medication.

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It's been over 2 weeks since my last systemic therapy, and I've mostly recovered from its side effects.

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My heart pumps well and I don't have serious fluid around it.

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I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need urgent treatment because my tumor is pressing on my spine or other organs.

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I have an active autoimmune disease like psoriasis or rheumatoid arthritis.

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I have or had multiple myeloma in my brain or spinal fluid.

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I do not have any ongoing serious infections, blood clotting issues, or uncontrolled major illnesses.

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I do not wish to receive intensive care treatments like ventilation or dialysis.

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I have had a stem cell transplant from a donor.

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I have spinal cord compression but no cancer in the spinal cord itself.

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I have not received genetically modified cells except in NCI gene therapy studies.

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I have active hemolytic anemia.

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I am taking blood thinners other than aspirin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each arm/group respectively.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each arm/group respectively.

This trial's timeline: 3 weeks for screening, Varies for treatment, and date treatment consent signed to date off study, approximately 16 months/17 days, 4 months/4 days, 4 months/18 days, 42 months/8 days, 20 months/19 days, 29 months/28 days, and 30 months/26 days for each arm/group respectively. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of Anti-B Cell Maturation Antigen (BCMA) - Chimeric Antigen Receptor (CAR)-T Cells

Number of Participants at Each Dose Level Who Experience a Dose-Limiting Toxicity (DLT)

Other study objectives

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: 2/Conditioning chemotherapy plus chimeric antigen receptors (CARs) T-cells expansion phaseExperimental Treatment3 Interventions

6.0x10\^6 dose (maximum feasible dose) of CAR T Cells + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg/m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3

Group II: 1/Conditioning chemotherapy plus chimeric antigen receptors (CARs) T-cells dose escalationExperimental Treatment3 Interventions

Patients will receive escalating doses (up to 5 planned) of CAR+ T cells infused on day 0 + Cyclophosphamide: 300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3 + Fludarabine: 30 mg /m\^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4, and -3

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860