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

Launched by WUGEN, INC. · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called WU-CART-007 for patients with relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (LBL). The goal of the study is to see how effective this treatment is at achieving a complete remission, meaning that there are no signs of cancer left in the body. Researchers are particularly interested in whether WU-CART-007 can help patients reach a state called "minimum residual disease negative," which means that the levels of cancer cells are undetectable.

To participate in the trial, candidates must be at least 1 year old and have been diagnosed with T-ALL or LBL that has either relapsed (come back after treatment) or has not responded to prior therapies. Participants will undergo careful screening to ensure they meet certain health criteria, including having adequate organ function and no active infections. If eligible, patients can expect to receive WU-CART-007 and will be monitored closely during the study. This trial is currently recruiting participants, and it aims to provide valuable information about this new treatment option for T-ALL and LBL patients.

Gender

ALL

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.