IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma

Trial ID or NCT#

NCT03902184

Status

not recruiting iconNOT RECRUITING

Purpose

This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.

Official Title

TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Exclusion Criteria:
  1. 1. Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening; 2. Receipt of live vaccines within 4 weeks prior to treatment; 3. Central nervous system (CNS) lymphoma involvement; 4. Prior administration of IPH4102; 5. Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study; 6. Autologous stem cell transplantation less than 3 months prior to enrollment; 7. Prior allogenic transplantation; 8. Patients who have undergone major surgery ≤ 4 weeks prior to study entry; 9. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection; 10. Patients who have Hepatitis B Virus infection determined as HBsAg positive and / or Hepatitis C Virus infection determined as detection of HCV RNA in serum or plasma by a sensitive quantitative molecular method; 11. Known or tested positive for human immunodeficiency virus (HIV); 12. Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-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 13. Pregnant or breastfeeding women; 14. Known clinically significant cardiovascular disease or condition, including: - Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification; - Any uncontrolled arrhythmia (per the investigator's discretion); - Uncontrolled hypertension (per the investigator's discretion). 15. Patients with autoimmune disease on systemic immunosuppressive treatment; 16. 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; 17. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.
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Investigator(s)

Youn H Kim, MD
Youn H Kim, MD
Dermatologic oncologist, Cutaneous oncology specialist, Dermatologist
The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Contact us to find out if this trial is right for you.

Contact

Mariel Rojas
650-723-0530

View on ClinicalTrials.gov