Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2

NCT05321147 | Completed Phase 1 FDA Drug

• 1 other identifier: IPH4102-102
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 20

Brief Summary

This is a multi-center phase Ib study, which evaluates the safety and efficacy of lacutamab monotherapy in patients with relapsed/refractory peripheral T-cell lymphoma that express KIR3DL2.

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events (AEs)

  Frequency and intensity of adverse events and serious adverse events.

  From consent is obtained until EOT visit (28 days after the last administration of study drug lacutamab)

Study Arms (1)

PTCL that express KIR3DL2

EXPERIMENTAL

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.

Biological: lacutamab

Interventions

lacutamab BIOLOGICAL

Patients will receive a fixed dose of 750mg as 1-hour IV infusion

Also known as: IPH4102

PTCL that express KIR3DL2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any subtype of PTCL;
• Patients should have received at least one prior line of systemic therapy;
• 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 The patients who have withdrawn from prior (N-1) line of systemic therapy due to unacceptable toxicity must have received at least 2 cycles of prior (N-2) line of therapy;
• KIR3DL2 expression (≥ 1%) based on central evaluation by IHC of either a newly acquired biopsy (preferred) or a tissue sample collected from a historical lymph node biopsy;
• Presence of at least 1 target lesion on PET/CT scan at screening;
• Male or Female, at least 18 years of age;
• ECOG performance status ≤ 2;
• The patient must have a minimum wash-out period of 3 weeks between the last dose of prior line of systemic therapy and first dose of lacutamab;
• Patients should have recovered from clinically relevant adverse events related to prior therapy to ≤ grade 1. Certain toxicities will not be considered in this category (e.g., Grade 2 alopecia, peripheral neuropathy and/or endocrine end-organ failure being adequately managed by hormone replacement therapy);
• Adequate baseline laboratory data:
• Hematology:
• Hemoglobin \>9 g/dL
• Absolute neutrophil count (ANC) ≥1,000/µL,
• Platelets ≥50,000/µL,
• Biochemistry:

You may not qualify if:

• Treatment with \> 8 lines of systemic therapies prior to enrollment. Consolidation therapy including stem cell transplant is not considered a line of therapy;
• Patients having a life expectancy of less than 3 months;
• Receipt of live vaccines within 4 weeks prior to treatment;
• Known central nervous system (CNS) lymphoma involvement;
• Prior treatment with lacutamab;
• Concurrent enrollment in another clinical trial, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study;
• Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents or immunotherapy;
• Autologous stem cell transplantation less than 3 months prior to enrollment;
• Prior allogenic transplantation;
• Patients who have undergone major surgery ≤ 4 weeks prior to study entry;
• Patients with known NCI-CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;
• Patients who have active Hepatitis B or C virus infection confirmed by PCR;
• Patients known or tested positive for human immunodeficiency virus (HIV);
• Patients with a history of other malignancies during the past three years apart from the disease subject of this study. The following are exempt from the three-year limit: non\_melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia, Ductal carcinoma in situ (DCIS) or cervical carcinoma in situ.
• Pregnant or breastfeeding women;

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (20)

University of Alabama at Birmingham- O'Neal Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

University of California at Irvine - Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Goshen Health- Goshen Hospital

Goshen, Indiana, 46526, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Memorial Sloan Kettering Cancer Center- David H. Koch Center for Cancer Care

New York, New York, 10065, United States

Location

Allegheny Health

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina - Health Hollings Cancer Center

Charleston, South Carolina, 29425, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, 07345, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, South Korea

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 11, 2022
• Study Start: March 17, 2022
• Primary Completion: November 19, 2023
• Study Completion: February 8, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

US (10); KR (10)