A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL
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ClinicalTrials.gov Identifier: NCT04984356 |
Recruitment Status :
Active, not recruiting
First Posted : July 30, 2021
Last Update Posted : November 24, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | July 29, 2021 | ||||
First Posted Date ICMJE | July 30, 2021 | ||||
Last Update Posted Date | November 24, 2023 | ||||
Actual Study Start Date ICMJE | January 14, 2022 | ||||
Estimated Primary Completion Date | May 2026 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL | ||||
Official Title ICMJE | A Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) | ||||
Brief Summary | The main purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL). | ||||
Detailed Description | This is a first-in-human, multicenter, Phase 1/2, single-agent study in patients with R/R T-ALL/T-LBL who have exhausted other treatment options. The study will consist of two phases, Phase 1 and Phase 2. During the Dose Escalation segment (Phase 1) up to 24 patients will be treated with 1 dose of WU-CART-007, in up to 4 dose levels until maximum tolerated dose (MTD) or maximum administered dose (MAD) is determined. The dose escalation segment will enroll successive cohorts of 3 to 6 patients using a standard 3 + 3 design. Once the recommended phase 2 dose (RP2D) is defined, the Phase 2 portion (Cohort Expansion) will enroll expansion cohorts. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Intervention Model Description: There are two parts to this study. Phase 1 will comprise of Dose Escalation, and Phase 2 Cohort Expansion. Phase 1 will determine the safety and tolerability of a single dose of WU-CART-007 and define the RP2D. The Cohort Expansion Phase, will further define the safety and evaluate the initial efficacy of WU-CART-007 at the dose established from the Phase 1 Dose Escalation segment. Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: WU-CART-007
A single IV infusion of WU-CART-007 Cells on Day 1
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Study Arms ICMJE | Experimental: WU-CART-007
A CD7-directed chimeric antigen receptor (CAR) T-cell product. A single IV infusion of WU-CART-007 Cells on Day 1 after Lymphodepletion(LD) Therapy. Intervention: Biological: WU-CART-007
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
44 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 2026 | ||||
Estimated Primary Completion Date | May 2026 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion/Exclusion Criteria: Specific inclusion criteria apply to each disease subtype. In general, all patients will have:
ii. Undergone allogeneic HSCT > 90 days prior to enrollment from a match related or unrelated donor, cord blood donor, haplo-identical, or autologous stem cells. iii. Off all immunosuppressive medications for a minimum of 2 weeks with the exception of physiologic doses of corticosteroids. iv. No prior history of Grade 2 or greater (per Cairo-Bishop) veno-occlusive disease (VOD)/sinusoidal obstruction syndrome, or active graft versus host disease (GvHD) (see exclusion criteria below for exceptions).
Patients will be excluded from study entry if:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, France, Netherlands, United States | ||||
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Administrative Information | |||||
NCT Number ICMJE | NCT04984356 | ||||
Other Study ID Numbers ICMJE | WU-CART-007 1001 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Wugen, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Wugen, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Wugen, Inc. | ||||
Verification Date | September 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |