Acute Myeloid Leukemia, in RelapsePhase 1AMpLifyNCT06128044
CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing CB-012 in people with Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, run by Caribou Biosciences, Inc. at 10 sites in United States.
Trial summary
CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets C-type lectin-like molecule-1 (CLL-1). This is a Phase 1 study to evaluate the safety, preliminary efficacy, and pharmacokinetics, of CB-012 (the study treatment) in adults with acute myeloid leukemia (AML) that has come back after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
- What is being tested?
- CB-012
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 10 sitesUnited States
- Study dates
- 8 Feb 2024to 30 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Documented diagnosis of AML with either refractory or relapsed disease,
- Non-proliferative disease
- No more than 3 prior lines of therapy (induction, consolidation with or without allogeneic stem cell transplant, and maintenance are considered 1 line of therapy)
- No available therapy with reasonable survival benefit
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 and fit for allogeneic stem cell transplant
- Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
- Women of child-bearing potential and men with a female partner who has child-bearing potential must agree to use acceptable, effective methods of birth control.
Who cannot join
- Acute promyelocytic leukemia
- Extra-medullary disease (EMD) that is metabolically inactive by 18-FDG PET-CT
- Prior treatment with CAR-T cell therapy
- Allogeneic stem cell transplant within 100 days before lymphodepletion
- Active graft-vs-host disease requiring therapy
- Known active or prior history of central nervous system involvement
Show all 12Show fewer
- Seropositive for or history of human immunodeficiency virus (HIV)
- Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion
- Active hepatitis B or C infection
- Primary immunodeficiency or autoimmune disease
- Known life-threatening allergies, hypersensitivity, or intolerance to CB-012 or its excipients
- Other inclusion and exclusion criteria may apply.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
The Blood & Marrow Transplant Group of Georgia (BMTGA)
Atlanta, Georgia, 30342
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249-0001
Colorado Blood Cancer Institute
Denver, Colorado, 80218
MD Anderson Cancer Center
Houston, Texas, 77030
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
TriStar Bone Marrow Transplant, LLC
Nashville, Tennessee, 37203
Weill Cornell Medical College
New York, New York, 10022
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, 10065
Fred Hutchinson Cancer Center
Seattle, Washington, 98109-1023
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: A Phase 1, Multicenter, Open-Label Study of CB-012, a CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets C-type lectin-like molecule-1 (CLL-1). This is a Phase 1 study to evaluate the safety, preliminary efficacy, and pharmacokinetics, of CB-012 (the study treatment) in adults with acute myeloid leukemia (AML) that has come back after prior treatment (relapsed) or did not respond or is no longer responding to other treatment (refractory). Participants must have received at least 1 but not more than 3 prior lines of treatment for AML .
- Being tested
- CB-012
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-012Drug
Also called Cyclophosphamide, Fludarabine
CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of CB-012 | Experimental | Part A (Dose Escalation) of CB-012 with increasing doses using a 3+3 design, during which the MTD and/or RDE will be identified. Receives: Drug: CB-012 |
| Dose Expansion of CB-012 | Experimental | Part B (Dose Expansion) - participants will be enrolled to receive CB-012 at the RDE and/or MTD determined in Part A in order to the determine the RP2D. Receives: Drug: CB-012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Part A) Number of patients with dose limiting toxicities (DLT)
Number of patients with DLTs during the 28 days following the first administration of CB-012.
Measured: 28 days
(Part B) Overall Response Rate (ORR)
The ORR will be evaluated by European Leukemia Net (ELN) criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start8 Feb 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Why it stopped: Sponsor Decision - Pipeline Reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, in RelapseStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caribou Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128044
- Sponsor's protocol ID
- CB12A
- Acronym
- AMpLify
- Status last verified
- May 2025
- First submitted
- 6 Nov 2023
- Last updated
- 11 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label Study of CB-012, a CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06128044
- Acronym / sponsor ID
- AMpLify / CB12A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision - Pipeline Reprioritization
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Caribou Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 13 Nov 2023 (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.
CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets C-type lectin-like molecule-1 (CLL-1). This is a Phase 1 study to evaluate the safety, preliminary efficacy, and pharmacokinetics, of CB-012 (the study treatment) in adults with acute myeloid leukemia (AML) that has come back after prior treatment (relapsed) or did not respond or is no longer responding to other treatment (refractory). Participants must have received at least 1 but not more than 3 prior lines of treatment for AML .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of CB-012 | Experimental | Drug: CB-012Part A (Dose Escalation) of CB-012 with increasing doses using a 3+3 design, during which the MTD and/or RDE will be identified. |
| Dose Expansion of CB-012 | Experimental | Drug: CB-012Part B (Dose Expansion) - participants will be enrolled to receive CB-012 at the RDE and/or MTD determined in Part A in order to the determine the RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented diagnosis of AML with either refractory or relapsed disease,
- Non-proliferative disease
- No more than 3 prior lines of therapy (induction, consolidation with or without allogeneic stem cell transplant, and maintenance are considered 1 line of therapy)
- No available therapy with reasonable survival benefit
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 and fit for allogeneic stem cell transplant
Key exclusion criteria (12 listed)
- Acute promyelocytic leukemia
- Extra-medullary disease (EMD) that is metabolically inactive by 18-FDG PET-CT
- Prior treatment with CAR-T cell therapy
- Allogeneic stem cell transplant within 100 days before lymphodepletion
- Active graft-vs-host disease requiring therapy
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-012Also: Cyclophosphamide, FludarabineCB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion | Drug | Dose Escalation of CB-012, Dose Expansion of CB-012 |
Primary outcome
(Part A) Number of patients with dose limiting toxicities (DLT)
Time frame: 28 days
Number of patients with DLTs during the 28 days following the first administration of CB-012.
(Part B) Overall Response Rate (ORR)
Time frame: 12 months
The ORR will be evaluated by European Leukemia Net (ELN) criteria
Results and safety
The study was stopped early (reason given: Sponsor Decision - Pipeline Reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CB-012 in people with Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, run by Caribou Biosciences, Inc. at 10 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 7 inclusion and 12 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: stopped early, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
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?
The study was stopped early (reason given: Sponsor Decision - Pipeline Reprioritization). Results are not available in the source record.
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?
(Part A) Number of patients with dose limiting toxicities (DLT) (time frame: 28 days). 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 11 Jun 2025.