Lymphoblastic Lymphoma, T-cell Acute Lymphoblastic Leukemia
Conditions
Keywords
CAR-T therapy
Brief summary
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).
Detailed description
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.
Interventions
BIOLOGICALWU-CART-007
A single IV infusion of WU-CART-007 Cells on Day 1
Sponsors
National Cancer Institute (NCI)
Wugen, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There are two parts to this study, Dose Escalation, and Expansion.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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),
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5 | 24 months | Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit |
| Maximum Tolerated Dose (MTD) | up to 28 days from first dose | Maximum tolerated or administered dose of WU-CART-007 |
Countries
Australia, France, Netherlands, United States
Outcome results
None listed