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CAR T-cell Therapy

ADI-001 for Non-Hodgkin's Lymphoma (GLEAN-1 Trial)

Phase 1

Waitlist Available

Research Sponsored by Adicet Therapeutics

Eligibility Criteria Checklist

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

Must have

Relapsed/refractory (R/R) previously treated B cell malignancies

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

Must not have

Current or history of central nervous system (CNS) primary lymphoma

Current or history of unrelated malignancy requiring systemic treatment in the past 3 years, other than hormonal treatment which is allowed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective. So far, the results look promising.

Who is the study for?

Adults with certain B cell malignancies who've had at least two prior treatments, including anti-CD20 antibody therapies. They must have measurable disease, be in good physical condition (ECOG PS of 0 or 1), and not pregnant or breastfeeding. Participants need to use effective birth control and can't join if they've had CNS lymphoma, recent unrelated cancers, gene therapy within six weeks, radiation within four weeks (except palliative), stem cell transplant within six weeks, or allogeneic transplant within three months.

What is being tested?

The trial is testing ADI-001 combined with Fludarabine and Cyclophosphamide in patients with various types of B-cell lymphomas. It's a Phase 1 study using a '3+3' design to find the safest dose that also works effectively against the cancer.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever and fatigue; organ inflammation; blood disorders due to bone marrow suppression from chemotherapy drugs like Fludarabine and Cyclophosphamide; infusion-related reactions; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My B cell cancer has returned or didn't respond to treatment.

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I am fully active or can carry out light work.

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I agree to use effective birth control during the study.

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I am not pregnant or breastfeeding.

Exclusion Criteria

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

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I have or had lymphoma in my brain or spinal cord.

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I haven't had any cancer treatments except for hormone therapy in the last 3 years.

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My tumor is causing problems like blocking my intestines or pressing on blood vessels.

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I haven't had gene or cell therapy in the last 6 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of treatment emergent and treatment related adverse events

The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort

Secondary study objectives

Frequency and persistence of ADI-001

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: ADI-001 Dose ExtensionExperimental Treatment3 Interventions

ADI-001 is administered via infusion at MAD/MTD to evaluate the safety of multiple doses (Part 1b).

Group II: ADI-001 Dose ExpansionExperimental Treatment3 Interventions

Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).

Group III: ADI-001 Dose EscalationExperimental Treatment3 Interventions

ADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001 (Part 1a).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310