We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05321147
Recruitment Status : Recruiting
First Posted : April 11, 2022
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Innate Pharma

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
Peripheral T Cell Lymphoma Biological: lacutamab Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 17, 2022
Estimated Primary Completion Date : December 28, 2022
Estimated Study Completion Date : April 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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 Name: IPH4102




Primary Outcome Measures :
  1. Occurrence of adverse events (AEs) [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05321147


Contacts
Layout table for location contacts
Contact: clinical trials clinical.trials@innate-pharma.fr

Locations
Show Show 19 study locations
Sponsors and Collaborators
Innate Pharma
Layout table for additonal information
Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT05321147    
Other Study ID Numbers: IPH4102-102
First Posted: April 11, 2022    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin