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CAR T-cell Therapy

NXC-201 CAR-T for Amyloidosis (NEXICART-2 Trial)

Phase 1

Recruiting

Led By Mehrdad Abedi

Research Sponsored by Nexcella Inc.

Eligibility Criteria Checklist

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

Must have

Subjects must have measurable disease at screening, including specific criteria related to serum M-protein and serum free light chain (FLC) assay

Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study

Must not have

Any prior systemic therapy for AL amyloidosis within specific time frames prior to leukapheresis or lymphodepletion

Subjects with known bulky central nervous system disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug to help people with a rare illness who have not been helped by other treatments.

Who is the study for?

This trial is for adults with relapsed or refractory light chain amyloidosis who have had previous treatments. They must not be pregnant, agree to birth control, and have measurable disease. People with inadequate organ function, recent other therapies, certain blood disorders, active infections or second malignancies are excluded.

What is being tested?

The study tests NXC-201 CAR-T cells' safety and effectiveness in treating AL amyloidosis that has returned or resisted treatment. It's an early-phase trial where the dose of NXC-201 will be increased gradually to find the right balance between efficacy and safety.

What are the potential side effects?

While specific side effects for NXC-201 CAR-T aren't listed here, common ones for similar therapies include fever, fatigue, immune reactions affecting different organs (like heart or liver), nerve issues, and a risk of infection due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be measured by blood tests.

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I am not pregnant and agree to use birth control during the study.

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My diagnosis of systemic AL amyloidosis is confirmed and requires treatment.

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I am 18 years old or older.

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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 have had treatment for AL amyloidosis before certain medical procedures.

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I have a significant brain tumor or brain metastases.

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My kidney function is not normal.

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I am currently on long-term immunosuppressant therapy.

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I am HIV positive and my viral load is not undetectable despite treatment.

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I do not have an active Hepatitis B or C infection.

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My bone marrow is not functioning properly.

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I have a history of heart conditions.

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My liver isn't working properly.

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

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

Primary study objectives

Number of Participants With Treatment-Related Adverse Events

Number of Participants with Adverse Events by Severity as Assessed by CTCAE v5.0

To confirm the maximum tolerated dose (MTD)

+1 more

Secondary study objectives

Percentage of participants with hematologic and organ response

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: NXC-201 CAR-TExperimental Treatment1 Intervention

The dose escalation phase will include the following doses: Cohort 1 - 150×10\^6 CAR-positive (CAR+) T cells (3 patients) Cohort 2 - 450×10\^6 CAR-positive (CAR+) T cells (3 patients) The dose expansion phase will then proceed.

0 / 14Eligibility criteria met