Long-Term Follow-up Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Caribou-sponsored investigational therapy: N/A this is an observational study

Study summary

This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.

Eligibility

Primary outcome measure(s)

• Incidence of targeted NSAEs — 15 Years
  Incidence of targeted NSAEs
• Frequency of targeted NSAEs — 15 Years
  Frequency of targeted NSAEs
• Duration of targeted NSAEs — 15 Years
  Duration of targeted NSAEs
• Outcome of targeted NSAEs — 15 Years
  Outcome of targeted NSAEs
• Incidence of AESIs — 15 Years
  Incidence of AESIs
• Frequency of AESIs — 15 Years
  Frequency of AESIs
• Duration of AESIs — 15 Years
  Duration of AESIs
• Outcome of AESIs — 15 Years
  Outcome of AESIs
• Incidence of targeted SAEs — 15 Years
  Incidence of targeted SAEs
• Frequency of targeted SAEs — 15 Years
  Frequency of targeted SAEs
• Duration of targeted SAEs — 15 Years
  Duration of targeted SAEs
• Outcome of targeted SAEs — 15 Years
  Outcome of targeted SAEs
• Incidence of AEs related to IP leading to death — 15 Years
  Incidence of AEs related to IP leading to death

Trial sites (31)