Lymphoma, Non-HodgkinLTFSNCT05332054
Long-Term Follow-up Study
An observational study of Lymphoma, Non-Hodgkin and Relapsed Non-Hodgkin Lymphoma, run by Caribou Biosciences, Inc. at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, Relapsed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Caribou-sponsored investigational therapy
- How many people
- 150 participants
- Where
- 31 sitesUnited States
- Study dates
- 16 Mar 2022to Dec 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received IP in a Caribou-sponsored clinical study, special access program, or IIT and provided informed consent for the LTFS
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
United States31 sites
Blood & Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
Augusta University/Georgia Cancer Center
Augusta, Georgia, 30912
University of Alabama
Birmingham, Alabama, 35233
Levine Cancer Center
Charlotte, North Carolina, 28204
Oncology Hematology Care
Cincinnati, Ohio, 45242
Cleveland Clinic
Cleveland, Ohio, 44195
University of Texas Southwestern
Dallas, Texas, 75235
Baylor Research Institute
Dallas, Texas, 75246
University of Colorado
Denver, Colorado, 80045
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Regional Cancer Care Associates - Hackensack
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of California Irvine
Irvine, California, 92868
University of California San Diego
La Jolla, California, 92093
University of Kentucky
Lexington, Kentucky, 40536
Norton Cancer Institute
Louisville, Kentucky, 40207
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Atlantic Health System Cancer Care
Morristown, New Jersey, 07960
Sarah Cannon Research Institute - TriStar Health
Nashville, Tennessee, 37203
Weill Cornell Medicine
New York, New York, 10021
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando, Florida, 32804
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University
Richmond, Virginia, 23284
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Honor Health Research Institute
Scottsdale, Arizona, 85258
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: An Observational Long-Term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy
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.
Read the 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.
- Conditions
- Lymphoma, Non-Hodgkin, Relapsed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Lymphoma, B Cell Lymphoma
- Being tested
- Caribou-sponsored investigational therapy
- Keywords
- Allogeneic CAR-T, CB-010, CB-011, CB-012
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma, Hematologic Neoplasms, Multiple Myeloma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caribou-sponsored investigational therapyBiological
N/A this is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed | consent for the LTFS Receives: Biological: Caribou-sponsored investigational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of targeted NSAEs
Incidence of targeted NSAEs
Measured: 15 Years
Frequency of targeted NSAEs
Frequency of targeted NSAEs
Measured: 15 Years
Duration of targeted NSAEs
Duration of targeted NSAEs
Measured: 15 Years
Outcome of targeted NSAEs
Outcome of targeted NSAEs
Measured: 15 Years
Incidence of AESIs
Incidence of AESIs
Measured: 15 Years
Frequency of AESIs
Frequency of AESIs
Measured: 15 Years
Duration of AESIs
Duration of AESIs
Measured: 15 Years
Outcome of AESIs
Outcome of AESIs
Measured: 15 Years
Incidence of targeted SAEs
Incidence of targeted SAEs
Measured: 15 Years
Frequency of targeted SAEs
Frequency of targeted SAEs
Measured: 15 Years
Duration of targeted SAEs
Duration of targeted SAEs
Measured: 15 Years
Outcome of targeted SAEs
Outcome of targeted SAEs
Measured: 15 Years
Incidence of AEs related to IP leading to death
Incidence of AEs related to IP leading to death
Measured: 15 Years
Secondary outcomes (1)
Overall survival
Assessment of overall survival and disease progression as described in the SOA
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start16 Mar 2022
- Primary completionDec 2041 (estimated)
- Study completionDec 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caribou Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332054
- Sponsor's protocol ID
- LTFS
- Acronym
- LTFS
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2022
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Long-Term Follow-up Study of Patients Who Received Prior Caribou Cell Therapy
- ClinicalTrials.gov ID
- NCT05332054
- Acronym / sponsor ID
- LTFS / LTFS
- Conditions
- Lymphoma, Non-Hodgkin, Relapsed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Lymphoma, B Cell Lymphoma
- Keywords
- Allogeneic CAR-T, CB-010, CB-011, CB-012
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Caribou Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- Dec 2041 (estimated)
- Study completion
- Dec 2041 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed | – | Biological: Caribou-sponsored investigational therapyconsent for the LTFS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received IP in a Caribou-sponsored clinical study, special access program, or IIT and provided informed consent for the LTFS
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caribou-sponsored investigational therapyN/A this is an observational study | Biological | Patients who received IP in a Caribou-sponsored, special access program or IIT and provided informed |
Primary outcome
Incidence of targeted NSAEs
Time frame: 15 Years
Incidence of targeted NSAEs
Frequency of targeted NSAEs
Time frame: 15 Years
Frequency of targeted NSAEs
Duration of targeted NSAEs
Time frame: 15 Years
Duration of targeted NSAEs
Outcome of targeted NSAEs
Time frame: 15 Years
Outcome of targeted NSAEs
Incidence of AESIs
Time frame: 15 Years
Incidence of AESIs
Frequency of AESIs
Time frame: 15 Years
Frequency of AESIs
Duration of AESIs
Time frame: 15 Years
Duration of AESIs
Outcome of AESIs
Time frame: 15 Years
Outcome of AESIs
Incidence of targeted SAEs
Time frame: 15 Years
Incidence of targeted SAEs
Frequency of targeted SAEs
Time frame: 15 Years
Frequency of targeted SAEs
Duration of targeted SAEs
Time frame: 15 Years
Duration of targeted SAEs
Outcome of targeted SAEs
Time frame: 15 Years
Outcome of targeted SAEs
Incidence of AEs related to IP leading to death
Time frame: 15 Years
Incidence of AEs related to IP leading to death
1 secondary outcome
Overall survival
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
B Acute Lymphoblastic Leukemia
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
RecruitingPhase 2
Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in Chimeric Antigen Receptor T-cell Immunotherapy (CAR-T): a Randomized Trial.
B-cell Lymphoma
RecruitingPhase 2
A Study to Evaluate Acalabrutinib, in Combination With the R-CHOP Standard of Care, for Previously Untreated Mantle Cell Lymphoma in Spain
Mantle-cell Lymphoma
Not yet recruitingObservational study
Biological Analysis of MABs in NHL in a Translational Prospective Observational Study Within Italian Clinical Practice
B-Cell Non-Hodgkin Lymphoma (NHL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma, Non-Hodgkin and Relapsed Non-Hodgkin Lymphoma, run by Caribou Biosciences, Inc. at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of targeted NSAEs (time frame: 15 Years). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.