Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies
調査の概要
状態
詳細な説明
Allogeneic stem cell transplantation is the treatment of choice for many patients with leukemia and other hematologic malignancies. However, a major limitation of this therapy is that for a significant number of patients no fully HLA-matched donor can be found. The application of partially HLA-matched (haploidentical) family donors, who are virtually always available, has some complications. If there is no T-cell add-back it increases the risk for life-threatening infections and disease relapse, while in case of T-cell add-back the risk of graft-versus-host disease is raised.
Kiadis Pharma has developed a method to selectively deplete host alloreactive T-cells through photodynamic therapy, using TH9402 ex vivo. The donor lymphocyte preparation depleted of functional alloreactive T-cells (ATIR) are administered to the patient 4-6 weeks after the stem cell transplant. This method enables early immune reconstitution while preventing graft-versus-host disease.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
Quebec
-
Montreal、Quebec、カナダ、H1T 2M4
- Maisonneuve-Rosemont Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS)
- Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient
- Life expectancy of at least 3 months
- Satisfactory performance status (ECOG ≤ 2);
Exclusion Criteria:
- Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor
- Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months;
- Pregnancy
- Viral hepatitis (B or C)
- Active serious infectious process
- HIV positivity;
- Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation
- Prior allogeneic transplantation
- Prior autologous transplantation within twelve months of baseline visit
- Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome
- Active central nervous system (CNS) disease at baseline
- Participation in a trial with an investigational agent within 30 days prior to entry in the study
- Malignant cells in circulating peripheral blood (> 25%)
- Other active malignant disease that would severely limit life expectancy
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：L1 (dose 1.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
実験的：L2 (dose 5.0x10E4 T-cells/kg)
|
Single intravenous infusion
|
|
実験的：L3 (dose 1.3x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
実験的：L4 (dose 3.2x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
実験的：L5 (dose 7.9x10E5 T-cells/kg)
|
Single intravenous infusion
|
|
実験的：L6 (dose 2.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
|
実験的：L7 (dose 5.0x10E6 T-cells/kg)
|
Single intravenous infusion
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Dose limiting toxicity, defined as acute graft-versus-host disease grade III or IV
時間枠：Within 30 days after ATIR infusion
|
Within 30 days after ATIR infusion
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Immune reconstitution
時間枠：Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Rate of disease relapse
時間枠：Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence and severity of graft-versus-host disease
時間枠：Until 60 months after ATIR infusion
|
Until 60 months after ATIR infusion
|
|
Occurrence of adverse drug reactions
時間枠：Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
|
Incidence and severity of infections
時間枠：Until 18 months after ATIR infusion
|
Until 18 months after ATIR infusion
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Denis-Claude Roy, MD、Maisonneuve-Rosemont Hospital, Montréal, Canada
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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