Table 1.

Patient disposition

Patients (N = 25)
ITT population, n25
mITT population, n25
Patient status at end of infusion 1 interventional phase, n (%)*25 (100)
 Disease progression22 (88)
 Did not progress3 (12)
Patient status at end of infusion 2 interventional phase (for patients with second infusion), n (%)*4 (16)
 Disease progression4 (16)
  • Patients completed the study if they discontinued because of disease progression or death after their last T-cell infusion, or if they were progression-free at the time of study completion (at Sponsor discretion) and moved into long-term follow-up. ITT population: all patients who were enrolled in the trial. mITT population: all patients in the ITT population who received ≥ 1 T-cell infusion.

  • * Denominator for percentages is based on the ITT population.

  • Did not progress by the time of the primary analysis; participation was terminated by the study sponsor.

  • One patient progressed before withdrawing consent.