Study of GI001 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia

This is an open-label, multi-cohort, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and preliminary efficacy of GI001 in adult patients with R/R B-NHL and R/R B-ALL. The study is divided into a Dose-Escalation Phase and a potential Dose-Expansion Phase. Dose-Escalation Phase * The dose-escalation phase evaluates four dose levels: 1 x 10E8 TU, 4 x 10E8 TU, 1.2 x 10E9 TU, and 2.4 x 10E9 TU. * Cohorts 1 and 2 utilize an accelerated titration design, initially enrolling 1 subject per cohort. * If a Dose-Limiting Toxicity (DLT), ‭$\\ge$‬ Grade 2 non-hematologic toxicity (occurring ‭$\\ge$‬ 2 times), or evidence of excessive CAR-T expansion occurs, the cohort switches to a standard "3+3" design. * Cohorts 3 and 4 follow a standard "3+3" escalation rule based on the occurrence of DLTs during a 28-day observation period. * A Safety Review Committee (SRC) will evaluate the safety data to determine dose escalation, Maximum Tolerated Dose (MTD), and Recommended Dose for Expansion (RDE). Dose-Expansion Phase * If applicable, 1 to 2 dose levels from the escalation phase will be selected as the RDE. * Approximately 12 to 18 additional subjects will be enrolled to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Study Procedures * Screening and Baseline: Eligible subjects undergo screening (Day -30 to Day -3) and baseline assessments (Day -2 to Day -1) to confirm eligibility and establish baseline status. * Treatment Administration: Subjects may receive premedication (e.g., promethazine or diphenhydramine) 15 to 30 minutes prior to infusion. GI001 is administered via a single intravenous infusion (lasting up to 2 hours) on Day 0. * Observation Period: Subjects will be hospitalized for at least 14 days post-infusion for close safety monitoring. The DLT observation period spans 28 days (Day 1 to Day 28). * Follow-up: Short-term follow-up continues until Day 90, followed by efficacy and safety evaluations every 3 months until Month 12, and then every 6 months until Month 24. * Long-Term Follow-up: After the 2-year period, subjects enter a 15-year long-term follow-up phase to monitor survival, delayed toxicities, and replication-competent lentivirus (RCL) risk.