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Recruiting
NCT06495723
Polyspecific Antibodies in Lymphoproliferative T-cell Disorders
Conditions: Peripheral T Cells Lymphoma (PTCL)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 54
Sponsor: Xenothera SAS
Location: CHU de Caen Caen
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 (PTCL) and to further evaluate its safety and tolerability at RP2D.
Eligibility Criteria
Inclusion Criteria:
1. Provide signed, written informed consent.
2. Is male or female, age ≥18 years old (at the time consent is obtained)
3. 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
* 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
4. 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.
5. Experienced disease progression during or after completion of most recent therapy or refractory disease.
6. Has a measurable lesion by imaging: the longest diameter should be ≥1.5 cm for nodal lesions and \>1 cm for extra-nodal lesions.
7. 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).
8. 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.
9. 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.
10. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
11. Has life expectancy of \>3 months.
12. 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) \
Source: ClinicalTrials.gov (NCT06495723). StuddyBuddy aggregates publicly available trial information.