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CAR T-cell Therapy

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

Phase 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

NEXICART-2 Trial 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.Check my eligibility

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.See study design

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.

NEXICART-2 Trial 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.

NEXICART-2 Trial 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

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 outcome measures

Percentage of participants with hematologic and organ response

NEXICART-2 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 - 450×10^6 CAR-positive (CAR+) T cells (3 patients) Cohort 2 - 800×10^6 CAR-positive (CAR+) T cells (3 patients) The dose expansion phase will include a dose of 800×10^6 CAR-positive (CAR+) T cells (3 or more patients)

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nexcella Inc.Lead Sponsor

1 Previous Clinical Trials

160 Total Patients Enrolled

Mehrdad AbediPrincipal InvestigatorUniversity of California, Davis

4 Previous Clinical Trials

77 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment for this experiment available to participants at the current time?

"This trial, whose original post date was January 1st 2024 and last update on October 19th 2023, is not currently recruiting. However, there are 104 other trials that prospective participants may apply to right now."

Answered by AI

Is there a possibility that I could be involved in this research endeavor?

"In order to be accepted onto this trial, applicants must have been diagnosed with amyloidosis and their age should sit somewhere between 18 and 120 years old. The study is looking for 40 volunteers in total."

Answered by AI

Does this medical research program accept participants who are over eighteen years of age?

"To participate in this medical trial, prospective patients must be aged 18 to 120 years old. Specifically, there are two trials for those below the legal age of consent and 104 studies for senior citizens over 65."

Answered by AI