Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Weidong Han, Ph.D
CONTACT
Lead
Chinese PLA General Hospital
Phase 1 (dose escalation) In phase 1, 6-18 subjects will be enrolled. Subjects will receive 3 doses of ATHENA-2 CAR-T cell therapy ( 1× 10\^6 cells/kg, 3× 10\^6 cells/kg, 6 × 10\^6 cells/kg) increases from low dose to high dose according to the "3 + 3" principle: Three (3) subjects are enrolled in a cohort corresponding to a dose level. If 1 subject in a cohort of 3 subjects experiences a dose-limiting toxicity (DLT), 3 additional subjects will be enrolled at the current dose level. For safety purposes, the administration of ATHENA-2 CAR T will be staggered by 28 days between the first two subjects in each cohort. And for each of the remaining cohorts, the administration of ATHENA-2 CAR-T will be staggered by 28 days before enter into the next cohort. Phase 2 (expansion cohort) In phase 2, 10 to 12 subjects will be enrolled and receive ATHENA-2 CAR-T cell infusion at dose of recommended phase 2 dose (RP2D), which will be determined based on the maximum tolerated dose (MTD), occurrence of DLT, the obtained efficacy results, pharmacokinetics/pharmacodynamics and other data according to the phase 1. Objectives: The primary objectives of the phase 1 are to evaluate the tolerability and safety of ATHENA-2 CAR-T in patients with r/r B-cell NHL, and determine RP2D. The primary purpose of the phase 2 study is to evaluate the efficacy of ATHENA-2 CAR-T in the above population.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
