B Cell Lymphoma, B-Cell Non-Hodgkin's Lymphoma, Hematologic Malignancy, Lymphoma, Lymphoma, Non-Hodgkin, Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, Relapsed/Refractory Multiple Myeloma
Conditions
Keywords
Allogeneic CAR-T, CB-010, CB-011, CB-012
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALCaribou-sponsored investigational therapy
N/A this is an observational study
Sponsors
Caribou Biosciences, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent (by patient or legal representative) obtained prior to study-specific activities/enrollment * Completed a Caribou-sponsored study or was administered Caribou IP under a special access program or as part of an IIT * Use of an effective method of birth control by women of childbearing potential and their partners and men with partners of childbearing potential (partners must also use an effective birth control method) through 12 months post IP infusion.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs related to IP leading to death | 15 Years | Incidence of AEs related to IP leading to death |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 15 years | Assessment of overall survival and disease progression as described in the SOA |
Countries
United States
Outcome results
None listed