Actively Recruiting
Polyspecific Antibodies in Lymphoproliferative T-cell Disorders
Led by Xenothera SAS · Updated on 2025-07-22
54
Participants Needed
8
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Polyspecific Antibodies in Lymphoproliferative T-cell Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed, written informed consent is provided.
- Male or female aged 18 years or older at consent.
- Histological diagnosis of relapsed or refractory PTCL subtypes per WHO 2022 classification.
- Received one or more prior systemic therapies including alkylating agents or anthracyclines; prior brentuximab vedotin required or contraindicated for ALCL.
- Disease progression during or after most recent therapy or refractory disease.
- Measurable lesion by imaging (nodal lesions 1.5 cm, extra-nodal lesions >1 cm).
- Recovered to less than Grade 1 or baseline from prior therapy toxicities; no major treatment within 2 weeks before starting.
- Available tissue samples or fresh tumor tissue for central pathology review.
- Able to provide bone marrow aspirate or biopsy within 3 months and agree to post-treatment biopsy if required.
- ECOG performance status 0 or 1.
- Life expectancy greater than 3 months.
- Adequate hematological and organ function meeting specified laboratory criteria.
- Able to understand and sign informed consent.
- Use adequate contraception during study and for 6 months after completing therapy.
You will not qualify if you...
- Bulky disease (tumor 10 cm).
- Central nervous system involvement by leukemia or lymphoma.
- Mature T-cell and NK-cell leukemias.
- T-lymphoblastic leukemia/lymphoma.
- Tumor-like lesions with T-cell predominance.
- Primary cutaneous T-cell lymphomas.
- Other active cancers or history of invasive cancer treatment within 3 years, except certain early-stage cancers.
- Recent systemic chemotherapy, targeted therapy, radiation, immunotherapy, or investigational drugs within specified time frames before study.
- Unresolved toxicity from prior treatments greater than Grade 1.
- Known HIV infection or active hepatitis B or C infection not meeting specific criteria.
- Active tuberculosis or infections requiring systemic therapy.
- Live vaccine within 35 days before first LIS1 dose.
- Pregnancy or nursing.
- Active or relapsing autoimmune disease except certain controlled conditions.
- Significant lung or cardiovascular diseases as specified.
- Cognitive impairment, active substance abuse, or psychiatric illness limiting consent or compliance.
- Known liver diseases or bleeding disorders.
- Psychological, social, or geographical conditions preventing compliance.
- Concurrent condition jeopardizing protocol compliance.
- Inability or unwillingness to comply with study procedures.
- Participants under legal protection in France.
- Participation in another therapeutic clinical study.
- Known hypersensitivity to polyclonal antibody.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
CHU de Caen
Caen, France, 14033
Actively Recruiting
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Actively Recruiting
3
CHU Henri-Mondor
Créteil, France, 94000
Actively Recruiting
4
CHU de Bordeaux - GH Sud - Hôpital Haut-Lévêque
Pessac, France, 33604
Actively Recruiting
5
CHU de Lyon - Hôpital Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
6
SC Ematologia Istituto Nazionale dei TumoriIRCCS Fondazione "G. Pascale"
Naples, Campania, Italy, 80131
Actively Recruiting
7
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
8
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy, 20133
Actively Recruiting
Research Team
F
Françoise SHNEIKER, MD
CONTACT
A
Alain BALEYDIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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