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.

Status and phase: Completed; Phase 1

Conditions: T-cell Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma

Treatments: Biological: WU-CART-007

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04984356

Wugen, Inc. is the sponsor. (Other Identifier)

WU-CART-007 1001

R35CA210084 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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),

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 1 patient group

WU-CART-007

Experimental group

Description:

A CD7-directed chimeric antigen receptor (CAR) T-cell product. A single IV infusion of WU-CART-007 Cells on Day 1 after lymphodepletion

Treatment:

Biological: WU-CART-007