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
Investigator Department
Medicine
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Blood & Bone Marrow Cancers --- HEMATOLOGIC NEOPLASMS
Blood & Bone Marrow Cancers --- MULTIPLE MYELOMA
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOID, ACUTE
Blood & Bone Marrow Cancers --- NEOPLASMS BY HISTOLOGIC TYPE
Cancer --- NEOPLASMS
Endocrine System Cancers --- NEOPLASMS
Gastrointestinal (GI) Cancers --- NEOPLASMS
Gynecologic Cancers --- NEOPLASMS
Lung & Chest Cancers --- NEOPLASMS
Prostate Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
Cancer --- NEOPLASMS BY SITE
Prostate Cancer --- NEOPLASMS BY SITE
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- NEOPLASMS, PLASMA CELL
Blood & Bone Marrow Cancers --- HEMOSTATIC DISORDERS
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- PARAPROTEINEMIAS
Blood & Bone Marrow Cancers --- BLOOD PROTEIN DISORDERS
Blood & Bone Marrow Cancers --- HEMORRHAGIC DISORDERS
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOID
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
MeSH Terms
LYMPHOMA, NON-HODGKIN
LYMPHOMA, B-CELL
LYMPHOMA
HEMATOLOGIC NEOPLASMS
MULTIPLE MYELOMA
LEUKEMIA, MYELOID, ACUTE
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
HEMIC AND LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
NEOPLASMS BY SITE
HEMATOLOGIC DISEASES
NEOPLASMS, PLASMA CELL
HEMOSTATIC DISORDERS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
PARAPROTEINEMIAS
BLOOD PROTEIN DISORDERS
HEMORRHAGIC DISORDERS
LEUKEMIA, MYELOID
LEUKEMIA