Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Innate Pharma

Stanford Investigator(s):

Intervention(s):

  • Biological: IPH4102

Phase:

Phase 2

Eligibility


Inclusion criteria

Cohort 1:

   1. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior
   systemic therapies;

   2. Prior treatment with mogamulizumab;

   3. Patients should have blood stage B2 at screening based on central evaluation by flow
   cytometry;

   4. Feasibility of obtaining at least one skin biopsy at screening;

   Cohorts 2 and 3:

   5. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;

   6. KIR3DL2 expression (Cohort 2) or non-expression (Cohort 3) in at least one skin lesion
   based on central evaluation by IHC;

   7. Patients should have received at least two prior systemic therapies;

   8. Feasibility of obtaining at least one skin biopsy at screening;

   Additional inclusion criteria applicable to all cohorts:

   9. Male or Female, at least 18 years of age;

10. ECOG performance status ≤2;

11. The patient must have a minimum wash-out period of 3 weeks between the last dose of
   prior systemic therapy and the first dose of IPH4102, except for mogamulizumab, a
   wash-out period of at least 8 weeks is required;

12. Patients should have recovered from all non-hematological adverse events related to
   prior therapy to ≤ grade 1 except for alopecia;

13. Adequate baseline laboratory data:

   Hematology:

      - Hemoglobin >9 g/dL,

      - Absolute neutrophil count (ANC) ≥1,500/µL,

      - Platelets ≥100,000/µL,

   Biochemistry:

      - Bilirubin ≤1.5 X upper limit of normal (ULN) or ≤3 X ULN for patients with
      Gilbert's disease,

      - Serum creatinine ≤1.5 X ULN,

      - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 X ULN.

14. Women of childbearing potential (WOCBP): Premenopausal females who had at least one
   menstrual cycle in the past 12 months and capable to become pregnant. They must have a
   negative serum beta-HCG pregnancy test result within seven days from start of
   treatment;

15. Women of childbearing potential and all men (and their female partners of childbearing
   potential) who are sexually active must agree to use adequate method of contraception
   at study entry, during treatment and for at least 9 months (270 days) following the
   last dose of study drug. Adequate methods are described in Appendix 11;

16. Signed informed consent form prior to any protocol-specific procedures.

Exclusion criteria

   1. Patients with evidence of large cell transformation (LCT) based on central histologic
   evaluation at screening;

   2. Concomitant corticosteroid use, systemic or topical. However, stable dosage of topical
   steroids (maximum strength Class III according to World Health Organization (WHO)
   Classification of Topical Corticosteroids) and/or systemic steroids (≤10 mg prednisone
   equivalent/day) are allowed, if patient has been on a stable dose for at least 4 weeks
   prior to treatment start. Inhaled steroids are allowed provided the presence of a
   concomitant medical condition that justifies the use;

   3. Receipt of live vaccines within 4 weeks prior the treatment;

   4. Central nervous system (CNS) lymphoma involvement;

   5. Prior administration of IPH4102;

   6. Concurrent enrollment in another clinical trial, unless it is an observational (non
   -interventional) clinical study or the follow-up period of an interventional study.

   7. Concomitant administration of radiotherapy or systemic anti-cancer therapy including
   but not restricted to: chemotherapy, biological agents, extracorporeal photopheresis
   (ECP) or immunotherapy;

   8. Autologous stem cell transplantation less than 3 months prior to enrollment;

   9. Prior allogenic transplantation;

10. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;

11. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral,
   bacterial, or fungal infection;

12. Patients who have active Hepatitis B or C virus infection;

13. Known or tested positive for human immunodeficiency virus (HIV);

14. 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;

15. Pregnant or breastfeeding women;

16. Patients with congestive heart failure, Class III or IV, by New York Heart Association
   (NYHA) criteria;

17. Patients with autoimmune disease on systemic immunosuppressive treatment;

18. 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;

19. Patients with dementia or altered mental status that would preclude understanding and
   rendering of informed consent document.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elle (Hyunjin) Kim
(650) 387-4436
Recruiting