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

Sponsor
Innate Pharma (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05321147
Collaborator
(none)
40
Enrollment
19
Locations
1
Arm
13.4
Anticipated Duration (Months)
2.1
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center phase Ib sutdy, which evaluates the safety and efficacy of lacutamab monotherpy in patients with relapse peripheral T-cell lymphoma that express KIR3DL2.

Condition or Disease Intervention/Treatment Phase
  • Biological: lacutamab
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-center Phase Ib Trial Evaluating the Safety and Efficacy of Lacutamab in Patients With Relapse Peripheral T-cell Lymphoma That Express KIR3DL2
Actual Study Start Date :
Mar 17, 2022
Anticipated Primary Completion Date :
Dec 28, 2022
Anticipated Study Completion Date :
Apr 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PTCL that express KIR3DL2

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
Patients will receive a fixed dose of 750mg as 1-hour IV infusion
Other Names:
  • IPH4102

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of adverse events (AEs) [From consent is obtained until EOT visit (28 days after the last administration of study drug lacutamab)]

      Frequency and intensity of adverse events and serious adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Any subtype of relapsed PTCL

    2. Patients should have received at least one prior systemic therapy including a CHOP-like chemotherapy;

    3. Presence of at least 1 target lesion on PET/CT scan at screening;

    4. Male or Female, at least 18 years of age;

    5. ECOG performance status ≤ 2;

    6. The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy;

    7. Patients should have recovered from all adverse events from prior therapies related to prior therapy to ≤ grade 1 except for alopecia. Some AE's from prior therapies maybe permitted after discussion and consultation with the medical monitor;

    8. Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12 months and capable to become pregnant. They must have a negative serum beta-HCG pregnancy test result within seven days before start of treatment;

    9. Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug

    10. Signed informed consent form prior to any protocol-specific procedure.

    Exclusion Criteria:

    1. Treatment with > 2 lines of systemic therapies prior to enrollment. Consolidation therapy including stem cell transplant is not considered a line of therapy;

    2. Primary refractory patients who progress while receiving first line systemic therapy;

    3. Patients having a life expectancy of less than 3 months;

    4. Receipt of live vaccines within 4 weeks prior to treatment;

    5. Central nervous system (CNS) lymphoma involvement;

    6. Prior treatment with lacutamab;

    7. Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study.

    8. Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents or immunotherapy;

    9. Autologous stem cell transplantation less than 3 months prior to enrollment;

    10. Prior allogenic transplantation;

    11. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;

    12. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;

    13. Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-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;

    14. Pregnant or breastfeeding women;

    15. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;

    16. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham- O'Neal Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 University of California at Irvine - Chao Family Comprehensive Cancer Center Orange California United States 92868
    3 Goshen Health- Goshen Hospital Goshen Indiana United States 46526
    4 Indiana University School of Medicine Indianapolis Indiana United States 46202
    5 University of Iowa Iowa City Iowa United States 52242
    6 University of Maryland Baltimore Maryland United States 21201
    7 Mount Sinai New York New York United States 10029
    8 Memorial Sloan Kettering Cancer Center- David H. Koch Center for Cancer Care New York New York United States 10065
    9 Allegheny Health Pittsburgh Pennsylvania United States 15224
    10 Medical University of South Carolina - Health Hollings Cancer Center Charleston South Carolina United States 29425
    11 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    12 Inje University Busan Paik Hospital Busan Korea, Republic of
    13 Seoul National University Bundang Hospital Gyeonggi-do Korea, Republic of
    14 Gachon University Gil Medical Center Incheon Korea, Republic of
    15 Asan Medical Center Seoul Korea, Republic of
    16 Korea University Anam Hospital Seoul Korea, Republic of
    17 Samsung Medical Center Seoul Korea, Republic of
    18 Seoul National University Hospital Seoul Korea, Republic of
    19 Severance Hospital Yonsei University Health System Seoul Korea, Republic of

    Sponsors and Collaborators

    • Innate Pharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Innate Pharma
    ClinicalTrials.gov Identifier:
    NCT05321147
    Other Study ID Numbers:
    • IPH4102-102
    First Posted:
    Apr 11, 2022
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral

    Study Results

    No Results Posted as of Apr 11, 2022