A Study of CTD402 in T-ALL/LBL Patients

TENACITY-01 is a single-arm, open-label, multi-center, Phase 1b/2 study to assess the safety and efficacy of CTD402 in pediatric and adolescents (≥ 1 to 17 years) and adult participants (≥ 18 years) with relapsed/refractory (r/r) T-ALL/LBL or T-ALL/LBL patients in remission but with MRD. The Phase 1b portion of the study will enroll up to 18 participants to evaluate the safety and establish the RP2D of CTD402 in both cohorts independently, which may be different. Up to 100 participants will be enrolled in the Phase 2 portion of the study to further confirm the efficacy and safety of CTD402; 36 participants will be enrolled in the R/R cohort and 66 participants will be enrolled in the MRD positive cohort. Both the phase 1b and phase 2 portions will consist of the following sequential phases: screening (up to 2 weeks), lymphodepletion period (within 7 days prior to treatment), CTD402 treatment (a single dose), primary follow-up period (up to 2 years). Once a participant receives the first dose of lymphodepleting chemotherapy regimen, the participant will be considered enrolled into the study. Long term follow-up will be conducted under a separate protocol until 15 years following CTD402 infusion for survival, toxicity, RCR monitoring, and secondary malignancy.