Clinical Trial 23547

• Overview

  Study Title:

  A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogenic CAR-T Cell Therapy, in Patients with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma(T-RRex)

  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.

  Objective:

  Primary Relapsed/Refractory Cohort: To evaluate the composite complete remission (CRc) rate assessment after WU-CART-007 administration in r/r T-ALL/LBL patients; CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with partial hematologic recovery (CRh) + CR with incomplete hematologic recovery (CRi). To evaluate the complete remission (CR) rate after WU-CART-007 administration in r/r T-ALL/LBL patients. MRD Positive Cohort: To evaluate the efficacy of WU-CART-007 to induce Minimal Residual Disease (MRD) negative response (defined as < 0.01% blasts in the bone marrow) as determined by a central flow-based MRD assay after WU-CART-007. The MRD response rate is defined as a proportion of patients achieving an MRD negative response. Secondary R/R Cohort: To evaluate duration of response (DOR) defined as, from the time from achievement of CRc (CR or CR or CRi; whichever occurs first), to relapse or death. To evaluate DOR or the time from achievement of CR to relapse or death. To evaluate the efficacy of WU-CART-007 to induce complete MRD response in patients with r/r T-ALL/LBL as determined by central flow-based MRD assay. To evaluate DOR or the time from achievement of CRc (CR, CRh, or CRi with MRD negative; whichever occurs first), to relapse or death due to T-ALL/LBL. To evaluate the percentage of patients who achieve best overall response (BOR) of CR or CRh or CRi at Month 6 without hematopoietic stem cell transplant (HSCT) between WU-CART-007 infusion and Month 6 response assessment. To evaluate the percentage of patients who achieve CR or CRh or CRi and then proceed to HSCT while in remission before Month 6 response assessment. To evaluate DOR following HSCT; defined as, from the time from achievement of CRc (CR or CRh or CRi; whichever occurs first), to relapse or death due to T-ALL. To evaluate DOR following HSCT from the time from achievement of CR to relapse or death due to T-ALL/LBL. To characterize the safety of WU-CART-007 in adult and pediatric patients with r/r T-ALL/LBL. To characterize cellular pharmacokinetics (Cmax, Tmax, AUC) of WU-CART-007 in blood over time. To evaluate the immunogenicity of WU-CART-007 i.e., development of anti-CAR antibodies and neutralizing antibodies. MRD Positive Cohort: To investigate the duration of response (DOR) and duration of MRD negativity after treatment with WU-CART-007. To evaluate the percentage of patients who achieve MRD negativity and then proceed to HSCT while in remission. To evaluate hematological (by morphology) relapse-free survival rate at 6 months following treatment with WU-CART-007. To evaluate the proportion of patients in relapse-free survival at 6 months post HSCT. To evaluate the time to morphologic relapse. To characterize the safety of WU-CART-007 in adult and pediatric patients with T-ALL/LBL in remission but with detectable MRD. Exploratory - see protocol *(too many characters to fit)

• Treatments

  Therapies:

  Cell Therapy; Chemotherapy (NOS)

  Medications:

  WU-CART-007 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

• 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 ≥ 1 year; adequate organ function
  • Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening (Adults age > 16) or Lansky Performance Status 70 and above (pediatrics/ adolescents age ≤16).

• Exclusion Criteria

  Key Inclusion 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.

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