A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies
A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies
This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Christine Dehner
- メール：christine.dehner@umoja-biopharma.com
研究連絡先のバックアップ
- 名前：Luke Walker, MD
- 電話番号：206-227-5056
- メール：luke.walker@umoja-biopharma.com
研究場所
-
-
California
-
Irvine、California、アメリカ、92618
- 募集
- City of Hope
-
コンタクト：
- Azra Borogovac, MD, MS
- メール：aborogovac@coh.org
-
主任研究者：
- Azra Borogovac, MD, MS
-
-
Tennessee
-
Nashville、Tennessee、アメリカ、37203
- 募集
- Sarah Cannon Research Institute
-
主任研究者：
- Krish Patel, MD
-
コンタクト：
- Clemence Walker
- メール：SCRI.DDUreferrals@scri.com
-
-
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:
- 18 years or older
- Provides voluntary written informed consent
- Relapsed or refractory large B-cell lymphoma (LBCL)
- Measurable disease according to Lugano 2014 criteria
- Confirmed CD22 expression
- No serious concomitant diseases or active/uncontrolled infections
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Current isolated central nervous system (CNS) involvement
- Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor [TCR] fusion constructs, TCR T cells, and CAR T cells)
- History of or active human immunodeficiency virus (HIV)
- Active or chronic hepatitis B, or active hepatitis C
- Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
- Ongoing CNS disease that would preclude neurologic assessment
- Uncontrolled angina or other acute heart disease
- Currently receiving treatment in another interventional clinical trial.
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：処理
- 割り当て：なし
- 介入モデル：順次割り当て
- 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：UB-VV400 + rapamycin
A single dose of UB-VV400 will be administered followed by treatment with rapamycin. |
UB-VV400 is a gene therapy that generates CD22-directed CAR T cells in the body. Rapamycin is a drug approved by the FDA for indications unrelated to cancer.
他の名前：
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1: Percentage of participants with common adverse events (AEs)
時間枠：Up to 2 years after UB-VV400 administration
|
Percentage of participants with commonly reported AEs overall and by severity |
Up to 2 years after UB-VV400 administration
|
|
Phase 2: Overall response rate (ORR)
時間枠：Up to 2 years after UB-VV4001 administration
|
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) |
Up to 2 years after UB-VV4001 administration
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1: Overall response rate (ORR)
時間枠：Up to 2 years after UB-VV400 administration
|
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) |
Up to 2 years after UB-VV400 administration
|
|
Phase 1 and Phase 2: Complete response rate (CRR)
時間枠：Up to 2 years after UB-VV400 administration
|
Percentage of participants with a best overall response (BOR) of complete response (CR) |
Up to 2 years after UB-VV400 administration
|
|
Phase 1 and Phase 2: Pharmacokinetics (PK) of UB-VV400
時間枠：Up to 8 days after UB-VV400 administration
|
Maximum concentration (Cmax), time to maximum concentration (Tmax), and AUC (area under the concentration vs time curve) for UB-VV400 |
Up to 8 days after UB-VV400 administration
|
|
Phase 2: Percentage of participants with common AEs
時間枠：Up to 2 years after UB-VV111 administration
|
Percentage of participants with commonly reported AEs overall and by severity |
Up to 2 years after UB-VV111 administration
|
|
Phase 2: Duration of response (DOR)
時間枠：Up to 2 years after UB-VV400 administration
|
Duration from first evidence of response (CR or PR) to date of first evidence of disease progression or death, whichever is earlier |
Up to 2 years after UB-VV400 administration
|
|
Phase 2: Progression-free survival (PFS)
時間枠：Up to 2 years after UB-VV400 administration
|
Duration from first administration of UB-VV400 to the first evidence of disease progression or death from any cause, whichever is earlier. |
Up to 2 years after UB-VV400 administration
|
|
Phase 2: Overall survival (OS)
時間枠：Up to 2 years after UB-VV400 administration
|
Duration from first administration of UB-VV400 to death from any cause |
Up to 2 years after UB-VV400 administration
|
|
Phase 2: Quality of life (QOL)
時間枠：Up to 2 years after UB-VV400 administration
|
Performance on 2 QoL scales: EuroQol instrument EQ-5D-5L and Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) |
Up to 2 years after UB-VV400 administration
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Luke Walker, MD、Umoja Biopharma
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- UB-VV400-03
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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