A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

Wugen, Inc.28 enrolled

Overview

The 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).

This is a first-in-human, multicenter, Phase 1, single-arm study in patients with R/R T-ALL/T-LBL who have exhausted other treatment options. The study evaluates dose escalation and dose expansion.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

T-cell Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma

Interventions

WU-CART-007BIOLOGICAL

A single IV infusion of WU-CART-007 Cells on Day 1

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Key Eligibility Criteria: * Diagnosed relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification * Adequate renal, hepatic, respiratory, and cardiovascular function * Life expectancy \>12 weeks * ECOG/Karnofsky performance status 0 or 1 at screening (Adults age \>16) or Lansky Performance Status 60 and above (adolescents ≤ 16),

Locations (12)

City of Hope

Duarte, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5

Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit

Time frame: 24 months

Maximum Tolerated Dose (MTD)

Maximum tolerated or administered dose of WU-CART-007

Time frame: up to 28 days from first dose

Data from ClinicalTrials.gov

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