Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant

Официальное название

A Pilot Study of the Impact of Recombinant Human Interleukin-7 (CYT107) on Tumor Clearance and Immune Reconstitution in Multiple Myeloma Patients After Autologous Hematopoietic Cell Transplant

Обзор

This is a two-arm, open-label, randomized, single-site, pilot study testing the addition of CYT107 following autologous hematopoietic cell transplant (AHCT) in patients with multiple myeloma (MM). The hypothesis of this study is that recombinant human CYT107 can be safely administered after AHCT and will promote quantitative and qualitative T cell reconstitution, which will be associated with enhanced tumor cell clearance and reduced infectious complications. Patients will be randomized to either the intervention arm that will receive CYT107 + standard of care melphalan and AHCT or to the control arm that will receive standard of care melphalan and AHCT only.

Вмешательства

• Препарат Recombinant glycosylated human interleukin-7
  Provided by RevImmune
• Препарат Melphalan
  Standard of care
• Процедура Autologous hematopoietic cell transplant
  Standard of care

Первичные конечные точки

• Rate of non-hematologic grade ≥3 CYT107 treatment-related AEs (excluding expected transplant-related AEs or AEs attributed to melphalan and ASCT) according to CTCAE v5 [Срок оценки: Through day 365]

Вторичные конечные точки (6)

• Rate of minimal residual disease (MRD) [Срок оценки: At Day 100]
• Rate of response by IMWG of ≥ complete response (CR) [Срок оценки: At Day 100]
• Rate of ≥ grade 3 infections [Срок оценки: Through day 365]
• Days from transplant until absolute neutrophil count (ANC) engraftment [Срок оценки: Through Day 30]
• Feasibility of treatment schedule [Срок оценки: 1 month post-transplant (transplant is on Day 0)]
• Absolute lymphocyte count (ALC) recovery from pre-AHCT [Срок оценки: Through Day 30]

Критерии участия

Критерии включения

• Confirmed diagnosis of multiple myeloma per IMWG criteria.
• Patient must be in first CR (including CR or sCR) or have PR or VGPR per IMWG criteria.
• Patient must be candidate for melphalan and AHCT in the opinion of the treating physician.
• At least 18 years of age.
• ECOG performance status ≤ 2
• Adequate bone marrow and organ function as defined below:

• Total bilirubin ≤ 2 x IULN
• AST(SGOT)/ALT(SGPT) ≤ 2.5 x IULN
• Creatinine clearance ≥ 30 mL/min by Cockcroft-Gault
• The effects of CYT107 on the developing human fetus are unknown. For this reason and also because many alkylating agents such as melphalan are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for one year post-transplant. Should a woman become pregnant or suspect she is pregnant, or a male suspect he has fathered a child during this time frame, s/he must inform the treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Критерии исключения

• High doses of corticosteroids (greater than 5 mg prednisone equivalent daily) within 2 weeks of Day -2, with exception of premedication as needed for mobilization regimen.
• A history of T-cell malignancy, plasma cell leukemia, or amyloidosis, or history of any other malignancy with the exceptions of in situ carcinomas, non-melanoma skin cancers, and malignancies for which all treatment was completed at least 2 years before Day -2 and the patient has no evidence of disease.
• Currently receiving any other investigational agents.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CYT107, melphalan, or other agents used in the study.
• Azathioprine, methotrexate, and anti-tumor necrosis factor agents within 2 weeks of Day -2.
• A history of congenital immunodeficiency syndrome or autoimmune disease. Patients with autoimmune disorders adequately controlled with medication (5 mg prednisone equivalent or less) are allowed.
• A history of clinically-significant pulmonary disorders, such as severe asthma, severe COPD, restrictive lung disease, pulmonary embolism within 3 months prior to study enrollment, or active or prior interstitial lung disease/pneumonitis.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of Day -2.
• Patients without a backup autologous stem cell graft available.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT06523699 · 202412127

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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