Peripheral T Cells Lymphoma (PTCL)Phase 1/2PALT1NCT06495723
Polyspecific Antibodies in Lymphoproliferative T-cell Disorders
A Phase 1/2 study testing LIS1 in people with Peripheral T Cells Lymphoma (PTCL), run by Xenothera SAS at 8 sites in 2 countries.
Trial summary
This is a 2-part study consisting of a Part 1, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), or Recommended Part 2 Dose (RP2D) of LIS1 as a single agent; followed by a Part 2, to investigate anti-tumors efficacy of LIS1 in selected subtypes of Peripheral TCell Lymphoma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cells Lymphoma (PTCL)
- What is being tested?
- LIS1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 9 Jul 2024to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Provide signed, written informed consent.
- Is male or female, age ≥18 years old (at the time consent is obtained)
- For Part 1: Has a histological diagnosis of the following relapsed or refractory PTCL based on WHO 2022 classification of lymphoid neoplasms
- Intestinal T-cell and NK cell lymphoid proliferations and lymphomas (without NK cell neoplasms)
- Hepatosplenic T-cell lymphoma
- Anaplastic large cell lymphoma
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- Nodal TFH cell lymphoma
- Other peripheral t-cell lymphomas For Part 2: The type of PTCL will be defined based on SC review after completion of Part 1 and will be documented in the protocol amendment
- Had previously received 1 or more appropriate systemic therapies, including an alkylating agent and/or anthracycline, for treatment of the current disease (radiation therapy alone would not be acceptable as previous therapy). Participants with ALCL must have received prior brentuximab vedotin or be unable to receive it due to allergy or intolerance.
- Experienced disease progression during or after completion of most recent therapy or refractory disease.
- Has a measurable lesion by imaging: the longest diameter should be ≥1.5 cm for nodal lesions and >1 cm for extra-nodal lesions.
- Experienced a toxicity of prior therapy: Participants must have recovered to less than Grade 1 or to baseline from toxicity of prior chemotherapy or biologic therapy and must not have had major surgery, chemotherapy, radiation, or biologic therapy within 2 weeks prior to beginning treatment.
- Note: Exceptions to this include events not considered to place the participant at unacceptable risk of participation in the opinion of the Investigator (e.g., alopecia).
- Has either unstained tissues (block or unstained slides) or stained slides and pathology report available for central review. If stained slides or unstained tissue are not available or insufficient, a fresh tumor tissue sample is mandatory for central pathology. Central pathology confirmation is not required prior to enrollment.
- Is able to provide a bone marrow aspirate and/or a biopsy no older than 3 months at screening and agrees to undergo post-treatment bone marrow aspirate or biopsy when required to confirm response.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has life expectancy of >3 months.
- Has an adequate hematological and organ function at screening, including:
- Hemoglobin ≥8.0 g/dL (prior transfusion is acceptable)
- Absolute neutrophil count (ANC) ≥1000 cells/mm3 (without growth factor support within 7 days of ANC measurement)
- Platelet count ≥50,000 cells/mm3 (without growth factor support or transfusion within 7 days of platelets measurement)
- Creatinine clearance ≥30 mL/min
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 × the upper limit of normal (ULN)
- Serum total bilirubin <2 × ULN OR <3 × ULN (for participants with Gilbert's Syndrome)
- Participants must be able to understand and sign an informed consent form.
- All participants must use adequate contraception during participation in this study and for 6 months following completing therapy.
Who cannot join
- Is diagnosed with a bulky disease (≥10 cm).
- Has known history or presence of central nervous system involvement by leukemia or lymphoma.
- Has Mature T-cell and NK-cell leukemias (WHO 2022 criteria)
- Has T-lymphoblastic leukemia/lymphoma (WHO 2022 criteria)
- Has tumor-like lesions with T-cell predominance (WHO 2022 criteria)
- Has Primary cutaneous T-cell lymphomas (WHO 2022 criteria)
Show all 45Show fewer
- Has any other active cancers, or history of treatment for invasive cancer ≤3 years.
- Note: Participants with stage I cancer who have received definitive local treatment at least 3 years previously and are considered unlikely to recur are eligible. All participants with previously treated in situ carcinoma (i.e., non-invasive) are eligible.
- Received any of the following treatments prior to the first dose of study medication:
- Systemic chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks (or 5 half-lives, whichever is shorter) before Cycle 1 Day 1. Participants that received local radiation therapy are eligible.
- Therapeutic anti-cancer antibodies <4 weeks
- Any investigational drug in the last 4 weeks prior
- Any major surgery or immunotherapy within 28 days
- Toxin immunoconjugates <4 weeks
- Nitrosoureas <6 weeks
- Allogeneic hematologic stem cell transplant within 3 months
- Adaptive cellular therapy such as autologous or donor natural killer cell or T lymphocyte infusions within 90 days
- Systemic corticosteroids (prednisone or equivalent >10 mg daily) within 2 weeks prior to the start of therapy, or 12 weeks if given to treat graft versus host disease (GVHD), except for physiological replacement doses of cortisone acetate or equivalent
- Systemic treatment for GVHD (including but not limited to oral or parenteral corticosteroids, ibrutinib, and extracorporeal phototherapy) within the last 12 weeks
- Is experiencing a toxicity (or AE) from prior anti-cancer treatment that has not resolved to Grade ≤1 or baseline.
- Has a known infection with human immunodeficiency virus (HIV) or serologic status reflecting active hepatitis B or C infection as follows:
- Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, are eligible only if hepatitis B virus (HBV) DNA is undetectable by an assay with sensitivity <20 IU/mL. If so, participants may either undergo regularly scheduled monitoring of HBV DNA or less frequent monitoring of HBV DNA while on prophylactic antiviral medication as defined by regional standard of care.
- Presence of hepatitis C virus (HCV) antibody. Participants with presence of HCV antibody are eligible only if HCV RNA is undetectable.
- Has a known active tuberculosis infection.
- Has an active fungal, bacterial, and/or viral infection requiring systemic therapy.
- Had a vaccination with a live vaccine within 35 days prior to the first dose of LIS1.
- If woman, is pregnant or nursing a child.
- Has an active autoimmune disease or history of autoimmune disease that may relapse except for type I diabetes under control, hypothyroidism managed with hormone replacement therapy, controlled celiac disease, and skin disease (vitiligo, psoriasis, etc.) not requiring systemic treatment.
- Has a known history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung disease, or dyspnea at rest or pulse oxymetrie < 92% at room air.
- Has a clinically significant cardiovascular disease including the following:
- Myocardial infarction or unstable angina within 3 months before screening
- Congestive heart failure (New York Heart Association functional classification III-IV)
- History of clinically significant arrythmias
- QTcF > 470 msec
- History of Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
- Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure >170 mm Hg and diastolic blood pressure >105 mmHg at screening
- Has a cognitive impairment, active substance abuse, or psychiatric illness or social situations that, in the view of the Investigator, would preclude safe treatment or the ability to give informed consent and limit compliance with study requirements.
- Has a known history of drug-induced liver injury, alcoholic liver disease, non- alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension.
- Has a hemophilia or von Willebrand's disease.
- Has any psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
- Has a concurrent condition that, in the Investigator's opinion, would jeopardize compliance with the protocol.
- Are unable or unwilling to comply with study and/or follow-up procedures outlined in the protocol.
- For France, participants under legal protection (safeguard, guardianship, curatorship).
- Is currently participating in another therapeutic clinical study.
- Has a known hypersensitivity to polyclonal antibody.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
France5 sites, 5 recruiting
- Recruiting
CHU de Caen
Caen, 14033
Gandhi-Laurent DAMAJ, damaj-gl@chu-caen.fr
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Olivier TOURNILHAC, MD, otournilhac@chu-clermontferrand.fr
- Recruiting
CHU Henri-Mondor
Créteil, 94000
Françoise LEMONNIER, MD, francois.lemonnier@aphp.fr
- Recruiting
CHU de Bordeaux - GH Sud - Hôpital Haut-Lévêque
Pessac, 33604
Kamal BOUABDALLAH, krimo.bouabdallah@chu-bordeaux.fr
- Recruiting
CHU de Lyon - Hôpital Lyon Sud
Pierre-Bénite, 69310
Emmanuel BACHY, emmanuel.bachy@chu-lyon.fr
Italy3 sites, 3 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138
Pier Luigi ZINZANI, MD
Cinzia PELLEGRINI, MD
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
Paolo Corradini, MD, +39 02 2390 2732, paolo.corradini@istitutotumori.mi.it
- Recruiting
SC Ematologia Istituto Nazionale dei TumoriIRCCS Fondazione "G. Pascale"
Naples, Campania, 80131
Antonio PINTO, MD
About this study
Official title: Phase I/II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of Glyco-humanized Polyclonal Antibody Directed Against Tumoral T Cells, in Patients With Relapsed/Refractory Peripheral T Cells Lymphoma (PTCL)
This is a 2-part study consisting of a Part 1, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), or Recommended Part 2 Dose (RP2D) of LIS1 as a single agent; followed by a Part 2, to investigate anti-tumors efficacy of LIS1 in selected subtypes of Peripheral TCell Lymphoma (PTCL) and to further evaluate its safety and tolerability at RP2D.
- Conditions
- Peripheral T Cells Lymphoma (PTCL)
- Being tested
- LIS1
- Keywords
- Relapsed Refractory PTCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIS1Drug
The study intervention (LIS1) is a glyco-humanized polyclonal antibody drug which is formulated for IV administration.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation part: dose 2 mg/kg | Experimental | Dose Escalation part: Dose level of LIS1: 2 mg/kg. Receives: Drug: LIS1 |
| Dose Escalation part: dose 4 mg/kg | Experimental | Dose Escalation part: Dose level of LIS1: 4 mg/kg. Receives: Drug: LIS1 |
| Dose Escalation part: dose 6 mg/kg | Experimental | Dose Escalation part: Dose level of LIS1: 6 mg/kg. Receives: Drug: LIS1 |
| Expansion part | Experimental | Expansion part: Participants will receive LIS1 at the RP2D determined in Part 1 of the study. Receives: Drug: LIS1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation part: Dose Limiting Toxicities (DLTs)
Incidence of DLTs in the first cycle
Measured: At the end of Cycle 1 (28 days)
Dose Escalation part: treatment emergent adverse events (TEAEs)
The severity of averse events (AEs) will be graded according to the NCI CTCAE, v5.0.
Treatment-emergent adverse events are defined as any AE with onset or worsening of a pre existing condition after the first dose of study intervention through 60 days following the last dose of study intervention.
Measured: After the first dose of study intervention through 60 days following the last dose of study intervention.
Expansion part: Anti-tumors efficacy
Objective response rate (ORR): defined as the proportion of participants with CR or PR assessed by Investigators according to Lugano criteria with the LYRIC modification for immunomodulatory drug.
Measured: Within 3 months after LIS1 initiation
Secondary outcomes (19)
Pharmacokinetics (PK) of LIS: Cmax
LIS1 peak plasma concentration (Cmax) in plasma
Measured: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: Tmax
Time to peak drug concentration in plasma (Tmax)
Measured: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: AUC
AUC24hours; AUC0-14days; AUC15-28days and AUC0-28days will be assessed
Measured: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: Ctrough
Trough concentration (Ctrough) is the concentration reached by LIS1 immediately before the next dose is administered
Measured: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: Cmin
Cmin for the minimum blood plasma concentration reached by LIS1 during the time interval between administration of two doses
Measured: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: T1/2
Half-life (T1/2) refers to the time required for plasma concentration of LIS1 to decrease
Measured: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: CL
Clearance (CL) is the volume of blood or plasma cleared of LIS1 from the body per unit of time
Measured: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: Vd
Volume of distribution (Vd) is defined as the total amount of LIS1 in the body divided by its concentration in plasma
Measured: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Host immunogenicity to LIS1
Number of participants who develop detectable anti-drug antibodies
Measured: Before and after (up to 5 min after the infusion) LIS1 infusion at Cycle1Day 1, Cycle1Day8, Cycle1Day15, and Cycle1Day22, then before infusion at Day1 and Day15 of Cycle2 to Cycle6 (each cycle is 28 days), and at Day30 and Day60 after last dose of LIS1
Expansion part: treatment emergent adverse events (TEAEs)
The severity of averse events (AEs) will be graded according to the NCI CTCAE, v5.0.
Treatment-emergent adverse events are defined as any AE with onset or worsening of a pre existing condition after the first dose of study intervention through 60 days following the last dose of study intervention.
Measured: After the first dose of study intervention through 60 days following the last dose of study intervention.
Expansion part: Proportion of Complete Response (CR) as best overall response
Proportion of Complete Response as best overall response
Measured: Within 3 months and 6 months after LIS1 initiation
Expansion part: Proportion of Partial Response (PR) as best overall response
Proportion of PR as best overall response
Measured: Within 3 months and 6 months after LIS1 initiation
Expansion part: Proportion of Stable Disease (SD) as best overall response
Proportion of SD as best overall response
Measured: Within 3 months and 6 months after LIS1 initiation
Expansion part: Proportion of Progressive Disease (PD) as best overall response
Proportion of PD as best overall response
Measured: Within 3 months and 6 months after LIS1 initiation
Expansion part: Duration of response (DoR)
DoR: defined as the time interval between the first confirmed objective response (CR or PR) and the first occurrence of objective progression (PD) or death from any cause.
Measured: Within 3 months and 6 months after LIS1 initiation
Expansion part: Time to response (TTR)
TTR: defined as the time from the date of LIS1 initiation to first confirmed objective response (CR or PR)
Measured: Within 3 months and 6 months after LIS1 initiation
Expansion part: Progression-free survival (PFS)
PFS: defined as the time from the date of LIS1 initiation to the date of first documented progression or death
Measured: Within 3 months and 6 months after LIS1 initiation
Expansion part: Overall survival (OS)
OS: defined as the time interval between the date of LIS1 initiation and the date of death due to any cause
Measured: Within 3 months and 6 months after LIS1 initiation
Expansion part: Proportion of patients "bridged to transplantation"
Proportion of patients with a stem cell transplantation after LIS1 treatment
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start9 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cells Lymphoma (PTCL)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xenothera SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gandhi-Laurent DAMAJ, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495723
- Sponsor's protocol ID
- XT 23-10
- Other IDs
- 2023-509648-88-00, 2023
- Acronym
- PALT1
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Open-label, Multi-center Study to Evaluate the Safety and Efficacy of Glyco-humanized Polyclonal Antibody Directed Against Tumoral T Cells, in Patients With Relapsed/Refractory Peripheral T Cells Lymphoma (PTCL)
- ClinicalTrials.gov ID
- NCT06495723
- Acronym / sponsor ID
- PALT1 / XT 23-10
- Conditions
- Peripheral T Cells Lymphoma (PTCL)
- Keywords
- Relapsed Refractory PTCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Xenothera SASIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jul 2024 (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 2-part study consisting of a Part 1, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), or Recommended Part 2 Dose (RP2D) of LIS1 as a single agent; followed by a Part 2, to investigate anti-tumors efficacy of LIS1 in selected subtypes of Peripheral TCell Lymphoma (PTCL) and to further evaluate its safety and tolerability at RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation part: dose 2 mg/kg | Experimental | Drug: LIS1Dose Escalation part: Dose level of LIS1: 2 mg/kg. |
| Dose Escalation part: dose 4 mg/kg | Experimental | Drug: LIS1Dose Escalation part: Dose level of LIS1: 4 mg/kg. |
| Dose Escalation part: dose 6 mg/kg | Experimental | Drug: LIS1Dose Escalation part: Dose level of LIS1: 6 mg/kg. |
| Expansion part | Experimental | Drug: LIS1Expansion part: Participants will receive LIS1 at the RP2D determined in Part 1 of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Provide signed, written informed consent.
- Is male or female, age ≥18 years old (at the time consent is obtained)
- For Part 1: Has a histological diagnosis of the following relapsed or refractory PTCL based on WHO 2022 classification of lymphoid neoplasms
- Had previously received 1 or more appropriate systemic therapies, including an alkylating agent and/or anthracycline, for treatment of the current disease (radiation therapy alone would not be acceptable as previous therapy). Participants with ALCL must have received prior brentuximab vedotin or be unable to receive it due to allergy or intolerance.
- Experienced disease progression during or after completion of most recent therapy or refractory disease.
Key exclusion criteria (45 listed)
- Is diagnosed with a bulky disease (≥10 cm).
- Has known history or presence of central nervous system involvement by leukemia or lymphoma.
- Has Mature T-cell and NK-cell leukemias (WHO 2022 criteria)
- Has T-lymphoblastic leukemia/lymphoma (WHO 2022 criteria)
- Has tumor-like lesions with T-cell predominance (WHO 2022 criteria)
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 |
|---|---|---|
| LIS1The study intervention (LIS1) is a glyco-humanized polyclonal antibody drug which is formulated for IV administration. | Drug | Dose Escalation part: dose 2 mg/kg, Dose Escalation part: dose 4 mg/kg, Dose Escalation part: dose 6 mg/kg, Expansion part |
Primary outcome
Dose Escalation part: Dose Limiting Toxicities (DLTs)
Time frame: At the end of Cycle 1 (28 days)
Incidence of DLTs in the first cycle
Dose Escalation part: treatment emergent adverse events (TEAEs)
Time frame: After the first dose of study intervention through 60 days following the last dose of study intervention.
The severity of averse events (AEs) will be graded according to the NCI CTCAE, v5.0. Treatment-emergent adverse events are defined as any AE with onset or worsening of a pre existing condition after the first dose of study intervention through 60 days following the last dose of study intervention.
Expansion part: Anti-tumors efficacy
Time frame: Within 3 months after LIS1 initiation
Objective response rate (ORR): defined as the proportion of participants with CR or PR assessed by Investigators according to Lugano criteria with the LYRIC modification for immunomodulatory drug.
19 secondary outcomes
Pharmacokinetics (PK) of LIS: Cmax
Time frame: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: Tmax
Time frame: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: AUC
Time frame: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: Ctrough
Time frame: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: Cmin
Time frame: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: T1/2
Time frame: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: CL
Time frame: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Pharmacokinetics (PK) of LIS: Vd
Time frame: At Cycle1Day 1 Predose and 5 minutes; 1; 2; 4; 8; 24 hours after the end of infusion. At Day1 and Day15 of Cycle2 to 6 (each cycle is 28 days): Predose and 5 minutes after the end of infusion. At Day 30 and Day60 after the last dose of LIS1.
Host immunogenicity to LIS1
Time frame: Before and after (up to 5 min after the infusion) LIS1 infusion at Cycle1Day 1, Cycle1Day8, Cycle1Day15, and Cycle1Day22, then before infusion at Day1 and Day15 of Cycle2 to Cycle6 (each cycle is 28 days), and at Day30 and Day60 after last dose of LIS1
Expansion part: treatment emergent adverse events (TEAEs)
Time frame: After the first dose of study intervention through 60 days following the last dose of study intervention.
Expansion part: Proportion of Complete Response (CR) as best overall response
Time frame: Within 3 months and 6 months after LIS1 initiation
Expansion part: Proportion of Partial Response (PR) as best overall response
Time frame: Within 3 months and 6 months after LIS1 initiation
Expansion part: Proportion of Stable Disease (SD) as best overall response
Time frame: Within 3 months and 6 months after LIS1 initiation
Expansion part: Proportion of Progressive Disease (PD) as best overall response
Time frame: Within 3 months and 6 months after LIS1 initiation
Expansion part: Duration of response (DoR)
Time frame: Within 3 months and 6 months after LIS1 initiation
Expansion part: Time to response (TTR)
Time frame: Within 3 months and 6 months after LIS1 initiation
Expansion part: Progression-free survival (PFS)
Time frame: Within 3 months and 6 months after LIS1 initiation
Expansion part: Overall survival (OS)
Time frame: Within 3 months and 6 months after LIS1 initiation
Expansion part: Proportion of patients "bridged to transplantation"
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Advanced Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
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To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL
Peripheral T Cell Lymphoma
RecruitingPhase 1/2
AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.
Lymphoma, Non-Hodgkin Lymphoma
RecruitingPhase 1
A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
Solid Tumors, Hematologic Malignancies
Active, not recruitingPhase 1/2
A Study to Assess the Safety, Tolerability, Efficacy, and Drug Levels of BMS-986369 (Golcadomide) in Participants With Relapsed or Refractory T-cell Lymphomas in Japan (GOLSEEK-3)
Relapsed or Refractory T-cell Lymphomas
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.
Gandhi-Laurent DAMAJ, MD principal investigator
University Hospital, Caen
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LIS1 in people with Peripheral T Cells Lymphoma (PTCL), run by Xenothera SAS at 8 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 26 inclusion and 45 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Italy. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Françoise SHNEIKER, MD (+33652720301, francoise.shneiker@xenothera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation part: Dose Limiting Toxicities (DLTs) (time frame: At the end of Cycle 1 (28 days)). The study lists 3 primary outcomes in all. 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 20 Aug 2026.