Imviva Bio
The goal of the TENACITY-01 clinical trial is to learn if CTD402 UCART is safe and effective for relapsed/refractory T-ALL/LBL patients. Participants with relapsed/refractory T-ALL/LBL over the age of 1 year will be eligible to participate. Participants will receive one infusion of CTD402 on Day 0 and will be evaluated for anti-tumor activity by an independent review committee based on the NCCN criteria for T-ALL and the Lugano 2014 criteria for T-LBL. Patients will be followed for up to 24 months in this study and will be required to enroll under a separate long term follow up protocol to be followed for up to 15 years.
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…
Key Inclusion Criteria: 1. Male or female, ≥ 1 year of age. 2. Participants with body weight ≥ 40 kilogram. 3. A) Relapsed or refractory T-ALL/LBL or MRD positive defined as one of the following: * Relapsed or refractory disease after two or more lines of systemic therapy; * The first relapse occurs within 12 months after first remission; * Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period. B) Minimal Residual Disease (MRD) positive T-ALL/LBL is defined as evidence of MRD, defined as \< 5% blasts in bone marrow but ≥ 1 cancer cell in 1,000 c…
CAR T cells