Lymphoblastic Lymphoma, T-cell Acute Lymphoblastic Leukemia
Conditions
Keywords
CAR-T Therapy, Acute Leukemia
Brief summary
The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response
Detailed description
This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.
Interventions
BIOLOGICALWU-CART-007
A single IV infusion of WU-CART-007
Sponsors
Allotera Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is divided into 2 cohorts: Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease Minimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease.
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive * Age: Lower age limit of ≥ 6 months; adequate organ function * Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening. Key
Exclusion criteria
* Prior treatment with any anti-CD7 therapy. * Patients with decompensated hemolytic anemia. * Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, United States
Contacts
CONTACTAllotera Therapeutics Clinical Trials Clinical Trials
STUDY_DIRECTORCherry Thomas, MD
Allotera Therapeutics
Outcome results
None listed