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Monoclonal Antibodies

Lacutamab for Peripheral T-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by Innate Pharma

Eligibility Criteria Checklist

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

Must have

ECOG performance status ≤ 2

Patient with documented refractory, relapsed, or progressive disease. Patients must receive at least 2 cycles of prior line of systemic therapy (N-1). The patients who have withdrawn from prior (N-1) line of systemic therapy due to unacceptable toxicity must have received at least 2 cycles of prior (N-2) line of therapy

Must not have

Treatment with > 8 lines of systemic therapies prior to enrollment. Consolidation therapy including stem cell transplant is not considered a line of therapy

Prior treatment with lacutamab

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from consent is obtained until eot visit (28 days after the last administration of study drug lacutamab)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new single drug to treat a specific type of relapse lymphoma in people who express a certain protein. They want to see if it's safe and works well.

Who is the study for?

This trial is for adults with Peripheral T-cell Lymphoma (PTCL) that's come back or hasn't responded to treatment. They must have tried at least one therapy, have a certain level of KIR3DL2 protein in their cancer cells, and be well enough overall to participate. Women who can get pregnant and men must use birth control during the study.

What is being tested?

The trial tests Lacutamab alone in PTCL patients whose disease has returned or resisted other treatments. It's an early-phase study looking at how safe the drug is and how effective it might be against this type of lymphoma.

What are the potential side effects?

While specific side effects for Lacutamab aren't listed here, similar drugs often cause immune reactions, fatigue, nausea, infections risk increase, blood count changes. Each person may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself but might not be able to do heavy physical work.

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My disease has not improved or has worsened despite treatment, and I've completed at least 2 cycles of a previous therapy.

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My kidney function, measured by creatinine, is within normal limits.

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My test shows at least 1% KIR3DL2 expression in my lymph node biopsy.

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My kidneys are working well enough, based on a specific test.

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My liver enzymes are within normal limits.

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I have a type of cancer known as peripheral T-cell lymphoma.

Exclusion Criteria

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

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I have had more than 8 different treatments for my condition, not counting stem cell transplants.

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I have been treated with lacutamab before.

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I do not have dementia or any condition that affects my ability to understand and agree to the study.

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I have not received any live vaccines in the last 4 weeks.

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My cancer has spread to my brain or spinal cord.

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I do not have a severe infection right now.

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I am not currently receiving any cancer treatments like chemotherapy or immunotherapy.

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I have an active Hepatitis B or C infection confirmed by a PCR test.

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I have severe heart failure.

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I have had a transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from consent is obtained until eot visit (28 days after the last administration of study drug lacutamab)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from consent is obtained until eot visit (28 days after the last administration of study drug lacutamab)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from consent is obtained until eot visit (28 days after the last administration of study drug lacutamab) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Occurrence of adverse events (AEs)

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: PTCL that express KIR3DL2Experimental Treatment1 Intervention

lacutamab will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lacutamab

Not yet FDA approved

0 / 17Eligibility criteria met