Spots Global Cancer Trial Database for 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

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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: 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)

Study ID: NCT04984356

Conditions

T-cell Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Interventions

WU-CART-007

Study Description

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.