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TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy. An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with advanced T-cell lymphoma.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507777-18-00
Acronym
IPH4102-201
Enrollment
104
Registered
2024-04-30
Start date
2019-03-19
Completion date
2025-12-23
Last updated
2025-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced T-Cell Lymphomas (TCL), i.e. Cutaneous T Cell Lymphomas (CTCL) CTCL subtypes under investigation: relapsed/refractory Sézary Syndrome (SS), stage IB to IV Mycosis Fungoides (MF).

Brief summary

Objective response rate (ORR). ORR is defined as the proportion of patients with complete or partial response.

Detailed description

1. Safety Assessment: - AEs, SAEs, change in clinical laboratory evaluations and vital signs., 3. Quality of life: obtained with the patient-reported VAS score for pruritus and QoL questionnaire SkinDex29., 4. Pharmacokinetic (PK) Assessment: Individual IPH4102 serum concentration., 5. Immunogenic potential of IPH4102: Immunogenicity results for each patient., 2.a. Other antitumor activity endpoints: - Duration of response measured from the first documentation of objective response (if subsequently confirmed) to the event of disease progression or death., 2.b. Other antitumor activity endpoints: - Objective response rate (ORR) review of disease response by central review (Cohort 1 only)., 2.c. Other antitumor activity endpoints: - Progression free survival (PFS) from the start of IPH4102 administration to documented progression or death from any cause., 2.d. Other antitumor activity endpoints: - Overall Survival (OS) measured from the start of IPH4102 administration to death from any cause.

Interventions

Sponsors

Innate Pharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective response rate (ORR). ORR is defined as the proportion of patients with complete or partial response.

Secondary

MeasureTime frame
1. Safety Assessment: - AEs, SAEs, change in clinical laboratory evaluations and vital signs., 3. Quality of life: obtained with the patient-reported VAS score for pruritus and QoL questionnaire SkinDex29., 4. Pharmacokinetic (PK) Assessment: Individual IPH4102 serum concentration., 5. Immunogenic potential of IPH4102: Immunogenicity results for each patient., 2.a. Other antitumor activity endpoints: - Duration of response measured from the first documentation of objective response (if subsequently confirmed) to the event of disease progression or death., 2.b. Other antitumor activity endpoints: - Objective response rate (ORR) review of disease response by central review (Cohort 1 only)., 2.c. Other antitumor activity endpoints: - Progression free survival (PFS) from the start of IPH4102 administration to documented progression or death from any cause., 2.d. Other antitumor activity endpoints: - Overall Survival (OS) measured from the start of IPH4102 administration to death from any c

Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026