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CAR T-cell Therapy

CT-0525 for HER2 Positive

Phase 1

Recruiting

Research Sponsored by Carisma Therapeutics Inc

Eligibility Criteria Checklist

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

Must have

Histologically confirmed recurrent or metastatic solid HER2-positive tumor with no available curative treatment options

Must have adequate hepatic function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial is testing a new treatment called anti-HER2 CAR-monocytes for patients with advanced cancer that has not responded to standard treatments. The goal is to see if this new treatment is safe and

Who is the study for?

This trial is for people with advanced or metastatic solid tumors that have high levels of HER2 and who haven't responded to standard treatments. Specific details about who can join are not provided, but typically participants need to meet certain health standards.Check my eligibility

What is being tested?

The study is testing a new treatment called CT-0525, which involves CAR-monocytes targeting the HER2 protein on cancer cells. It's an early-phase trial assessing safety, how well patients tolerate the treatment, and if it can be made reliably.See study design

What are the potential side effects?

Since this is a first-in-human study for CT-0525, exact side effects aren't listed. However, similar therapies often cause immune reactions, fatigue, fever, and potential harm to normal tissues with HER2.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned or spread, tests positive for HER2, and cannot be cured with treatment.

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My liver is working well.

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My tumor is HER2-positive after the latest treatment, confirmed by tests.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assess the feasibility of manufacturing CT-0525.

Assess the safety and tolerability of CT-0525 by estimating the frequency and severity of adverse events in participants with HER2 overexpressing solid tumors.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CT-0525Experimental Treatment1 Intervention

Cohort 1: 3 participants will be treated with a single IV administration of CT-0525 (3 billion CAR positive cells) on Day 1. Cohort 2: 3 participants will be treated with a single IV administration of CT-0525 (10 billion CAR positive cells) on Day 1.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carisma Therapeutics IncLead Sponsor

1 Previous Clinical Trials

48 Total Patients Enrolled

Daniel CushingStudy DirectorCarisma Therapeutics Inc

Frequently Asked Questions

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

Is this medical study currently open to new participants?

"As per clinicaltrials.gov, this study is actively seeking participants. The trial was initially listed on January 8th, 2024, and most recently revised on February 9th of the same year."

Answered by AI

What is the upper limit of participants involved in this clinical study?

"Affirmative, the details on clinicaltrials.gov indicate that this investigation is currently seeking volunteers. Originally shared on January 8th, 2024, and last revised on February 9th, 2024, it aims to recruit six participants from a single site."

Answered by AI

What is the safety profile of CT-0525 in individuals?

"The safety of CT-0525 is rated as 1 by our team at Power, reflecting the early Phase 1 nature of the trial with limited evidence supporting its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors

2024. "CAR-monocytes for the Treatment of HER2 Overexpressing Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06254807.

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