Study of IPH4102 in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)

Not Recruiting

Trial ID: NCT02593045


The primary objective of this first in human study is to assess the safety and tolerability of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a Maximum Tolerated Dose (MTD).

Official Title

Open Label, Multicenter Phase I Study of IPH4102, a Humanized Anti-KIR3DL2 Monoclonal Antibody, in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)

Stanford Investigator(s)

Youn H Kim, MD
Youn H Kim, MD

The Joanne and Peter Haas, Jr., Professor for Cutaneous Lymphoma Research and Professor, by courtesy, of Medicine (Oncology)

Michael Khodadoust
Michael Khodadoust

Assistant Professor of Medicine (Oncology) and of Dermatology


Inclusion Criteria:

   1. Patients with relapsed/refractory, biopsy-proven primary cutaneous T-cell lymphoma who
   have received at least two previous standard systemic therapies and, if MF/SS, is
   stage IB IVB at study entry.

   2. Centrally assessed KIR3DL2 expression on tumor cells.

   3. Patients must have the following minimum wash-out from previous treatments:

      - ≥12 weeks for total skin electron beam irradiation,

      - ≥4 weeks for monoclonal antibodies (≥8 weeks for alemtuzumab),

      - ≥3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy,
      treatment with other anti-neoplastic investigational agents

      - ≥3 weeks for systemic retinoids, interferons, vorinostat, romidepsin, fusion

      - ≥3 weeks for phototherapy

      - ≥2 weeks for topical therapy (including steroids, retinoids, nitrogen mustard or
      imiquimod) Topical steroids (maximum strength: medium potency) and oral steroids
      (≤10 mg prednisone equivalent/day) are allowed, if the patient has been on a
      stable dose with stable symptoms for at least 4 weeks prior to study entry.

   4. At least 18 years of age.

   5. ECOG performance status of ≤2.

   6. Adequate baseline laboratory data: hemoglobin >9 g/dL, absolute neutrophil count (ANC)
   ≥1,000/µL, CD4+ T-cells ≥200/µL, platelets ≥50,000/µL, 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) ≤3 X ULN.

   7. Women of childbearing potential (WOCBP) must have a negative serum beta-HCG pregnancy
   test result within seven days of treatment and must practice an effective method of
   contraception during treatment and for at least 9 months (270 days) following the last
   dose of study drug.

   8. Female patients who are post-menopausal or surgically sterile.

   9. Male patients who agree to practice effective barrier contraception.

10. Ability to understand and the willingness to sign a written informed consent document.

11. No psychological, familial, sociological, or geographical condition potentially
   hampering compliance with the study protocol and follow-up schedule.

Exclusion Criteria:

   1. Patients with limited disease (if MF/SS: stages IA) or central nervous system (CNS)

   2. Clinical relevant AEs or laboratory results related to previous anti-neoplastic
   therapy have not resolved to a NCI-CTCAE grade ≤1.

   3. Concomitant corticosteroid use, systemic or topical, for treatment of skin disease.
   However, topical steroids (maximum strength: medium potency) and oral steroids (≤10 mg
   prednisone equivalent/day) are allowed, if patient has been on a stable dose with
   stable symptoms for at least 4 weeks prior to study entry.

   4. Patients who have undergone major surgery <4 weeks prior to starting study drug.

   5. Patients who have undergone a stem cell transplantation.

   6. Patients with known NCI CTCAE Grade 3 or higher (requiring IV antibiotics) active
   systemic or cutaneous viral, bacterial, or fungal infection.

   7. Patients who are Hepatitis B or Hepatitis C antibody positive.

   8. Patients who are known to be HIV-positive.

   9. Prior hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins,
   or immunotherapy.

10. Patients with a history of other malignancies during the past three years. (The
   following are exempt from the three-year limit: non-melanoma skin cancer, Lymphomatoid
   papulosis, curatively treated localized prostate cancer, curatively treated localized
   breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial
   neoplasia or cervical carcinoma in situ).

11. Patients who are currently pregnant or breastfeeding.

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

13. Patients with any serious underlying medical condition that would impair their ability
   to receive or tolerate the planned treatment.

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


biological: IPH4102

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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