Peripheral T Cell LymphomaPhase 1NCT05321147
Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2
A Phase 1 study testing lacutamab in people with Peripheral T Cell Lymphoma, run by Innate Pharma at 20 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- lacutamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 17 Mar 2022to 8 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 The patients who have withdrawn from prior (N-1) line of systemic therapy due to unacceptable toxicity must have received at least 2 cycles of prior (N-2) line of therapy;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;
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- 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:
- Bilirubin ≤1.5 X upper limit of normal (ULN) or ≤3 X ULN for patients with Gilbert's disease,
- Serum creatinine ≤1.5 X ULN,
- Creatinine clearance ≥30 mL/min, assessed using the Cockcroft \& Gault formula
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3 X ULN;
- 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;
- 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
- Signed informed consent form prior to any protocol-specific procedure being performed.
Who cannot join
- 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;
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- 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;
- Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria;
- 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;
- Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
United States10 sites
University of Maryland
Baltimore, Maryland, 21201
University of Alabama at Birmingham- O'Neal Comprehensive Cancer Center
Birmingham, Alabama, 35294
Medical University of South Carolina - Health Hollings Cancer Center
Charleston, South Carolina, 29425
Goshen Health- Goshen Hospital
Goshen, Indiana, 46526
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Memorial Sloan Kettering Cancer Center- David H. Koch Center for Cancer Care
New York, New York, 10065
University of California at Irvine - Chao Family Comprehensive Cancer Center
Orange, California, 92868
Allegheny Health
Pittsburgh, Pennsylvania, 15224
South Korea10 sites
Inje University Busan Paik Hospital
Busan
Chungnam National University Hospital
Daejeon, 35015
Seoul National University Bundang Hospital
Gyeonggi-do
Gachon University Gil Medical Center
Incheon
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, 07345
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
About this study
Official title: A Multi-center Phase Ib Trial Evaluating the Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2
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.
Read the detailed description
This is an open-label, single-arm multicenter study. Eligible patients will be enrolled and will receive fixed dose of 750mg Lacutamab as a 1-hour IV infusion.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- lacutamab
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lacutamabBiological
Also called IPH4102
Patients will receive a fixed dose of 750mg as 1-hour IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: lacutamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs)
Frequency and intensity of adverse events and serious adverse events.
Measured: From consent is obtained until EOT visit (28 days after the last administration of study drug lacutamab)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start17 Mar 2022
- Primary completion19 Nov 2023
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innate Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321147
- Sponsor's protocol ID
- IPH4102-102
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase Ib Trial Evaluating the Safety and Efficacy of Lacutamab in Patients With Relapsed/Refractory Peripheral T-cell Lymphoma That Express KIR3DL2
- ClinicalTrials.gov ID
- NCT05321147
- Acronym / sponsor ID
- IPH4102-102
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Innate PharmaIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, single-arm multicenter study. Eligible patients will be enrolled and will receive fixed dose of 750mg Lacutamab as a 1-hour IV infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTCL that express KIR3DL2 | Experimental | Biological: lacutamablacutamab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lacutamabAlso: IPH4102Patients will receive a fixed dose of 750mg as 1-hour IV infusion | Biological | PTCL that express KIR3DL2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lacutamab in people with Peripheral T Cell Lymphoma, run by Innate Pharma at 20 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (AEs) (time frame: From consent is obtained until EOT visit (28 days after the last administration of study drug lacutamab)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.