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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
Any subtype of PTCL
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

Study 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.Check my eligibility
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.See study design
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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I have a type of peripheral T-cell lymphoma.
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I have not taken any cancer treatment drugs for at least 3 weeks.
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I have mostly recovered from side effects of my previous cancer treatment.
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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 cancer has not responded to or has worsened after treatment, and I've completed at least 2 cycles of a previous therapy.
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My kidneys are functioning well enough for treatment.
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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 test shows KIR3DL2 expression in my biopsy.
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My kidney function, measured by creatinine, is within normal limits.
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I have undergone at least one round of systemic therapy.
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I am a woman who can become pregnant and have had a period in the last year. My pregnancy test before treatment was negative.
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I am 18 years old or older.
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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.

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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of adverse events (AEs)

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.

Find a Location

Who is running the clinical trial?

Innate PharmaLead Sponsor
27 Previous Clinical Trials
3,021 Total Patients Enrolled

Media Library

Lacutamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05321147 — Phase 1
Peripheral T-Cell Lymphoma Research Study Groups: PTCL that express KIR3DL2
Peripheral T-Cell Lymphoma Clinical Trial 2023: Lacutamab Highlights & Side Effects. Trial Name: NCT05321147 — Phase 1
Lacutamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05321147 — Phase 1

Frequently Asked Questions

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

Is the clinical trial running in North America being conducted at multiple locations?

"There are 11 medical sites offering this clinical trial, such as Goshen Health-Goshen Hospital in Goshen and Allegheny Health in Pittsburgh. Additionally, the University of California at Irvine - Chao Family Comprehensive Cancer Center is participating in Orange, along with 8 other centres."

Answered by AI

How many individuals are being enrolled in this medical experiment?

"To facilitate the completion of this medical trial, 40 qualified patients are required. Potential participants can sign up at either Goshen Health-Goshen Hospital in Indiana or Allegheny Health in Pittsburgh, Pennsylvania."

Answered by AI

Has lacutamab received the regulatory go-ahead from the Food and Drug Administration?

"Lacutamab's safety was cautiously evaluated and given a score of 1 as this clinical study is only in its first phase, with limited data available to assess efficacy."

Answered by AI

Are there still vacancies available in this experiment for participants?

"According to clinicaltrials.gov, this trial is presently recruiting patients. It was initially made available on March 17th 2022 and the details were most recently updated on April 4th 2022."

Answered by AI
~13 spots leftby Mar 2025