Clinical trial NCT06514794: 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
Official title: A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: T-cell Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Keywords: CAR-T Therapy
Lead sponsor: Wugen, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 125
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is divided into 2 disease Cohorts:

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.

Minimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease (\>0.1% but \<5% BM blasts).
Primary purpose: TREATMENT

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. An exploratory MRD positive cohort will evaluate patients in complete remission with MRD positive disease (\>0.1 but \< 5% blasts in the BM)

Data for each age group will be reviewed by the Data Safety Committee (DSC) following enrollment of 12 patients.

Eligibility 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, 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: R/R Cohort - Composite Complete Response Rate
timeFrame: 24 months
measure: MRD Pos Cohort - Response Rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Saint Louis
country: United States
facility: Washington University Saint Louis
state: Missouri
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Melbourne
country: Australia
facility: Peter Mac Callum Cancer Institute
state: Victoria
city: Melbourne
country: Australia
facility: Royal Children's Melbourne
state: Victoria
Study officials:
affiliation: Wugen, Inc.
name: Cherry Thomas, MD
role: STUDY_DIRECTOR
References: