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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

Tracking Information
First Submitted Date  ICMJE April 4, 2022
First Posted Date  ICMJE April 11, 2022
Last Update Posted Date April 11, 2022
Actual Study Start Date  ICMJE March 17, 2022
Estimated Primary Completion Date December 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2022)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Lacutamab in Patients With Relapse Peripheral T-cell Lymphoma That Express KIR3DL2
Official Title  ICMJE A Multi-center Phase Ib Trial Evaluating the Safety and Efficacy of Lacutamab in Patients With Relapse Peripheral T-cell Lymphoma That Express KIR3DL2
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral T Cell Lymphoma
Intervention  ICMJE Biological: lacutamab
Patients will receive a fixed dose of 750mg as 1-hour IV infusion
Other Name: IPH4102
Study Arms  ICMJE 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.
Intervention: Biological: lacutamab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2022)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 28, 2023
Estimated Primary Completion Date December 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: clinical trials clinical.trials@innate-pharma.fr
Listed Location Countries  ICMJE Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05321147
Other Study ID Numbers  ICMJE IPH4102-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Innate Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Innate Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Innate Pharma
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP