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CAR T-cell Therapy

T-Cell Therapy for Non-Hodgkin's Lymphoma (STARLIGHT-1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Estrella Biopharma, Inc.

Eligibility Criteria Checklist

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

Must have

Age 18 years or older at the time of informed consent

Possess the capacity to understand the trial requirements, potential risks, benefits and voluntarily signs a written informed consent prior to any study procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time frame: up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called EB103 in adults with relapsed or refractory B-cell non-Hodgkin lymphoma. They will gradually increase the dose to find the safest and most

Who is the study for?

Adults over 18 with relapsed/refractory B-cell Non-Hodgkin's Lymphoma can join this trial. They should understand the risks and benefits, have good organ function, and an ECOG score of ≤2 (which means they are able to carry out daily activities). Prior treatments must be completed with stable side effects not worse than Grade 1.

What is being tested?

The trial is testing EB103, a new T-cell therapy for those whose lymphoma has returned or didn't respond to treatment. It starts by finding the best dose and then checks how well it works in more people at that dose.

What are the potential side effects?

Possible side effects include symptoms related to immune responses such as fever, fatigue, chills, breathing difficulties; there may also be risk of infection due to changes in blood cells.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I understand the study's risks and benefits and have signed the consent form.

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My condition is relapsed or refractory B-cell non-Hodgkin's lymphoma.

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I have undergone treatment combining chemotherapy and immunotherapy.

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I can take care of myself and am up and about more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time frame: up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time frame: up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103.

Incidence rates of Treatment-Emergent Adverse Events of EB103.

To assess the Dose Limiting Toxicities of EB103.

+1 more

Secondary study objectives

To assess the Disease Control Rate of EB103 in our study subject population.

To assess the Duration of Response of EB103 in our study subject population.

To assess the Event-Free Survival rate of EB103 in our study subject population.

+6 more

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: EB103Experimental Treatment1 Intervention

Approximately six (6) subjects will be treated to determine the RP2D. At the designated RP2D, approximately fifteen (15) additional subjects will be treated.

0 / 5Eligibility criteria met