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.
Brief Title
Long-Term Follow-up Study
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Lymphoma, Non-Hodgkin
Relapsed Non-Hodgkin Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Lymphoma
B Cell Lymphoma
B-Cell Non-Hodgkin's Lymphoma
Hematologic Malignancy
Relapsed/Refractory Multiple Myeloma
Relapsed/Refractory Acute Myeloid Leukemia
Eligibility Criteria
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
* 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
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Allogeneic CAR-T
CB-010
CB-011
CB-012
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05332054
Org Class
Industry
Org Full Name
Caribou Biosciences, Inc.
Org Study Id
LTFS
Overall Status
Enrolling by invitation
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
An Observational Long-Term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy
Primary Outcomes
Outcome Description
Incidence of targeted NSAEs
Outcome Measure
Incidence of targeted NSAEs
Outcome Time Frame
15 Years
Outcome Description
Frequency of targeted NSAEs
Outcome Measure
Frequency of targeted NSAEs
Outcome Time Frame
15 Years
Outcome Description
Duration of targeted NSAEs
Outcome Measure
Duration of targeted NSAEs
Outcome Time Frame
15 Years
Outcome Description
Outcome of targeted NSAEs
Outcome Measure
Outcome of targeted NSAEs
Outcome Time Frame
15 Years
Outcome Description
Incidence of AESIs
Outcome Measure
Incidence of AESIs
Outcome Time Frame
15 Years
Outcome Description
Frequency of AESIs
Outcome Measure
Frequency of AESIs
Outcome Time Frame
15 Years
Outcome Description
Duration of AESIs
Outcome Measure
Duration of AESIs
Outcome Time Frame
15 Years
Outcome Description
Outcome of AESIs
Outcome Measure
Outcome of AESIs
Outcome Time Frame
15 Years
Outcome Description
Incidence of targeted SAEs
Outcome Measure
Incidence of targeted SAEs
Outcome Time Frame
15 Years
Outcome Description
Frequency of targeted SAEs
Outcome Measure
Frequency of targeted SAEs
Outcome Time Frame
15 Years
Outcome Description
Duration of targeted SAEs
Outcome Measure
Duration of targeted SAEs
Outcome Time Frame
15 Years
Outcome Description
Outcome of targeted SAEs
Outcome Measure
Outcome of targeted SAEs
Outcome Time Frame
15 Years
Outcome Description
Incidence of AEs related to IP leading to death
Outcome Measure
Incidence of AEs related to IP leading to death
Outcome Time Frame
15 Years
Secondary Outcomes
Outcome Description
Assessment of overall survival and disease progression as described in the SOA
Outcome Time Frame
15 years
Outcome Measure
Overall survival
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients who received IP in a Caribou-sponsored clinical study, special access program, or IIT and provided informed consent for the LTFS
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Noah Kornblum
Investigator Email
nkornblu@montefiore.org
Investigator Phone
718-920-4826