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CAR T-cell Therapy

CDR404 for Cancer

Phase 1

Recruiting

Research Sponsored by CDR-Life AG

Eligibility Criteria Checklist

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

Must have

HLA-A*02:01 positive

Eastern Cooperative Oncology Group (ECOG) performance status (ECOG PS) 0 or 1

Must not have

Ongoing treatment with systemic steroids or other immunosuppressive therapies

Significant secondary malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

Awards & highlights

Summary

"This trial is testing a new antibody called CDR404 for treating certain cancers that have a specific marker called MAGE-A4. The study aims to see if CDR404 is safe and effective in

Who is the study for?

This trial is for adults with certain advanced solid tumors that show the MAGE-A4 marker and have the HLA-A*02:01 tissue type. Participants must be in good physical condition, have relapsed or not responded to standard treatments, and have measurable disease. They should also have proper organ function and agree to use effective contraception if applicable.

What is being tested?

CDR404, a new antibody designed to target cancers expressing the MAGE-A4 antigen, is being tested for safety and effectiveness. This first-in-human study will assess how well CDR404 works against these specific tumors in participants with the right genetic markers.

What are the potential side effects?

As this is a first-in-human study of CDR404, potential side effects are not yet fully known but may include typical reactions related to immune-based cancer therapies such as fatigue, fever, allergic reactions or autoimmune-like conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am HLA-A*02:01 positive.

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I am fully active or have some restrictions but can still care for myself.

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My condition did not improve with standard treatments.

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My tumor is MAGE-A4 positive.

Exclusion Criteria

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

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I am currently taking steroids or other drugs that weaken my immune system.

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I have another serious cancer besides the one being treated.

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I do not have any uncontrolled illnesses.

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I have brain metastases that are causing symptoms or have not been treated.

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I recently had cancer treatment and haven't waited long enough to start a new one.

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I am still experiencing major side effects from my previous cancer treatment.

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I have a serious heart condition.

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I am at risk for AIDS due to my HIV status.

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I have active hepatitis B or C.

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I have an autoimmune disease that needs ongoing treatment.

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I am currently on antibiotics for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 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

Anti-tumor response: Overall Response Rate (ORR)

Incidence and severity of (serious) adverse events ([S]AEs)

Presence of dose limiting toxicities (DLTs)

Secondary outcome measures

Accumulation ratio of CDR404 (Rac)

Area under the CDR404 serum concentration over time curve (AUC0-T)

Average serum concentration of CDR404 (Cavg)

+11 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CDR404Experimental Treatment1 Intervention

Dose escalation

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

CDR-Life AGLead Sponsor

~28 spots leftby Jun 2026

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