A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
- Conditions
- T-cell Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma
- Interventions
- Registration Number
- NCT06514794
- Lead Sponsor
- Wugen, Inc.
- Brief Summary
The main purpose of this study is to evaluate the Composite Complete Remission Rate (CRc) of WU-CART-007 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) patients and to evaluate the efficacy of WU-CART-007 to induce complete Minimum Residual Disease (MRD) negative response
- Detailed Description
This is a Phase 2, single-agent study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.
The study is divided into 2 disease Cohorts. The Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease, defined as ≥5% blast in the BM and/or extramedullary disease (EMD) only. The Minimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease (0.01-\< 5% blasts in the BM)
Enrollment will begin with a safety lead-in for both cohorts (R/R and MRDpos) at a reduced dose to confirm that the safety data obtained from adults and adolescents demonstrated in the Phase 1/2 trial is comparable for pediatric patients ages 1-11. This lead-in will also include a group of patients ages 12 and older to validate the prior safety data and serve as control for the lead-in patients ages 1-11. There will be at least 12 patients that participate in the safety lead-in (three patients younger than 12 years old and three aged 12 or older in each cohort).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 125
-
Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive, defined as:
- Relapsed or Refractory Cohort: disease defined by bone marrow with ≥5% lymphoblasts by morphologic assessment or flow cytometry or evidence of extramedullary disease (EMD).
- Minimal Residual Disease (MRD) Cohort: evidence of MRD, defined as < 5% blasts in bone marrow but ≥ 0.01% blasts determined by central laboratory flow cytometry assay
-
Adequate Organ Function
-
Age: Lower age limit of ≥ 1 year.
-
Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/60 and above at Screening (Adults age > 16) or Lansky Performance Status 60 and above (pediatrics/ adolescents age ≤16).
Key
- Treatment with any prior anti-CD7 therapy.
- Patients with decompensated hemolytic anemia.
- Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression (e.g. steroids). Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WU-CART-007 WU-CART-007 A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion Therapy.
- Primary Outcome Measures
Name Time Method R/R Cohort - Composite Complete Response Rate 24 months CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)
MRD Pos Cohort - Response Rate 24 months Defined as the efficacy of WU-CART-007 to induce complete MRD negative response
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
City of Hope
🇺🇸Duarte, California, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Washington University Saint Louis
🇺🇸Saint Louis, Missouri, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Peter Mac Callum Cancer Institute
🇦🇺Melbourne, Victoria, Australia
Royal Children's Melbourne
🇦🇺Melbourne, Victoria, Australia