Lymphoma, Non-HodgkinPhase 1NCT04637763
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
A Phase 1 study testing CB-010, Cyclophosphamide and Fludarabine in people with Lymphoma, Non-Hodgkin and Relapsed Non Hodgkin Lymphoma, run by Caribou Biosciences, Inc. at 38 sites in 3 countries.
Trial summary
CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine. 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?
- CB-010, Cyclophosphamide and Fludarabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 26 May 2021to 31 Dec 2026
- Phase
- Phase 1
- 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
Who may be able to join
- Age greater than or equal to 18 at the time of enrollment
- Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Who cannot join
- Prior therapy with an anti-CD19 targeting agent
- Active or chronic graft versus host disease requiring therapy
- Prior allogeneic stem cell transplantation
- Central nervous system (CNS) lymphoma, prior CNS malignancy
- Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
- Primary immunodeficiency
Show all 10Show fewer
- Current or expected need for systemic corticosteroid therapy
- Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted
- Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence
- Unwillingness to follow extended safety monitoring
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
United States31 sites
Bone and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
Augusta University/Georgia Cancer Center
Augusta, Georgia, 30912
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Oncology Hematology Care
Cincinnati, Ohio, 45242
Ohio State University Medical Group
Columbus, Ohio, 43210
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Regional Cancer Care Associates LLC - Hackensack
Hackensack, New Jersey, 07601
MD Anderson Cancer Center
Houston, Texas, 77030-4009
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of California San Diego Moores Cancer Center
La Jolla, California, 92073
University of Kentucky
Lexington, Kentucky, 40536
University of Arkansas
Little Rock, Arkansas, 72205
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90089
Norton Cancer Institute
Louisville, Kentucky, 40207
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Atlantic Health System
Morristown, New Jersey, 07960
Vanderbilt University Medical Center
Nashville, Tennessee, 37323
NYU Langone Health
New York, New York, 10016
Montefiore Medical Center
New York, New York, 10461
Virginia Oncology Associates
Norfolk, Virginia, 23502
Chao Family Comprehensive Cancer Center/University of California Irvine
Orange, California, 92868
Advent Health
Orlando, Florida, 32803
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23219
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
HonorHealth
Scottsdale, Arizona, 85258
Swedish Cancer Institute
Seattle, Washington, 98104
University of Arizona Cancer Center
Tucson, Arizona, 85724
Israel4 sites
Hadassah Medical Center
Jerusalem, 9112001
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492
The Tel Aviv Sourasky Medical Center
Tel Aviv, Tel Aviv-Yafo, 6423906
The Sheba Fund for Health Services and Research (R.A.)
Tel HaShomer, 5265601
Australia3 sites
Royal Perth Hospital
Perth, Western Australia, 6000
Epworth Healthcare
Richmond, Victoria, 3121
Westmead Hospital
Westmead, New South Wales, 2145
About this study
Official title: A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.
Read the detailed description
This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.
- Conditions
- Lymphoma, Non-Hodgkin, Relapsed Non Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Non Hodgkin Lymphoma, Lymphoma, B Cell Lymphoma
- Being tested
- CB-010, Cyclophosphamide, Fludarabine
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-010Genetic
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
CyclophosphamideDrug
Chemotherapy for lymphodepletion
FludarabineDrug
Chemotherapy for lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of CB-010 | Experimental | Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. Receives: Genetic: CB-010; Drug: Cyclophosphamide; Drug: Fludarabine |
| Expansion of CB-010 | Experimental | Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. Receives: Genetic: CB-010; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures number of patients with dose-limiting toxicities (Part A).
Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.
Measured: 28 days following CB-010 infusion
Primary outcome evaluates tumor response (Part B)
The primary endpoint is objective response rate.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start26 May 2021
- Primary completion11 Sep 2025
- Study completion31 Dec 2026 (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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The CB10A clinical study consists of (Part A) 3 + 3 design with three dose levels. (Part B) Expansion portion patients will receive CB-010 at the dose determined in Part A.
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT04637763
- Sponsor's protocol ID
- CB10A
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2020
- Last updated
- 19 Oct 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
- ClinicalTrials.gov ID
- NCT04637763
- Acronym / sponsor ID
- CB10A
- Conditions
- Lymphoma, Non-Hodgkin, Relapsed Non Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Non Hodgkin Lymphoma, Lymphoma, B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Caribou Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2020 (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.
CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.
Detailed description
This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The CB10A clinical study consists of (Part A) 3 + 3 design with three dose levels. (Part B) Expansion portion patients will receive CB-010 at the dose determined in Part A.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of CB-010 | Experimental | Genetic: CB-010, Drug: Cyclophosphamide, Drug: FludarabinePatients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. |
| Expansion of CB-010 | Experimental | Genetic: CB-010, Drug: Cyclophosphamide, Drug: FludarabinePatients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 at the time of enrollment
- Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Key exclusion criteria (10 listed)
- Prior therapy with an anti-CD19 targeting agent
- Active or chronic graft versus host disease requiring therapy
- Prior allogeneic stem cell transplantation
- Central nervous system (CNS) lymphoma, prior CNS malignancy
- Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
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 |
|---|---|---|
| CB-010CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19. | Genetic | Dose Escalation of CB-010, Expansion of CB-010 |
| CyclophosphamideChemotherapy for lymphodepletion | Drug | Dose Escalation of CB-010, Expansion of CB-010 |
| FludarabineChemotherapy for lymphodepletion | Drug | Dose Escalation of CB-010, Expansion of CB-010 |
Primary outcome
Primary outcome measures number of patients with dose-limiting toxicities (Part A).
Time frame: 28 days following CB-010 infusion
Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.
Primary outcome evaluates tumor response (Part B)
Time frame: Up to 12 months
The primary endpoint is objective response rate.
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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CB-010, Cyclophosphamide and Fludarabine in people with Lymphoma, Non-Hodgkin and Relapsed Non Hodgkin Lymphoma, run by Caribou Biosciences, Inc. at 38 sites in 3 countries.
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 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Israel, Australia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary outcome measures number of patients with dose-limiting toxicities (Part A). (time frame: 28 days following CB-010 infusion). The study lists 2 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 19 Oct 2026.