This section highlights FDA-related milestones and regulatory updates for drugs developed by Caribou Biosciences (CRBU).
Over the past two years, Caribou Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CB-011, CB-010, and CB-012. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
CB-011 FDA Regulatory Timeline and Events
CB-011 is a drug developed by Caribou Biosciences for the following indication: Allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CB-011
- Announced Date:
- May 12, 2026
- Indication:
- Allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology.
Announcement
Caribou Biosciences, Inc announced two abstracts have been accepted for oral presentations at the 2026 European Hematology Association (EHA) Annual Meeting, which will be held June 11-14, 2026, in Stockholm, Sweden.
Read Announcement- Drug:
- CB-011
- Announced Date:
- March 31, 2026
- Indication:
- Allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology.
Announcement
Caribou Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CB-011 for relapsed or refractory multiple myeloma (r/r MM).
AI Summary
Caribou Biosciences announced the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CB-011 for relapsed or refractory multiple myeloma. The decision was based on promising initial data from a 12-patient, BCMA‑naïve cohort in the CaMMouflage phase 1 trial: a 92% overall response rate, 75% achieving complete response or better, and 91% minimal residual disease (MRD) negativity. Those figures reflect the recommended dose-for-expansion results and were key to the RMAT grant.
Caribou is continuing dose expansion enrollment with both BCMA‑naïve and BCMA‑exposed cohorts. The company expects initial dose expansion results and longer follow-up from dose escalation in 2026. RMAT status is intended to speed development by enabling more intensive FDA interactions and potentially faster review, which could help advance CB-011 toward patients more quickly if future data remain strong.
Read Announcement- Drug:
- CB-011
- Announced Date:
- February 4, 2026
- Indication:
- Allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology.
Announcement
Caribou Biosciences, Inc. announced presentations at the 2026 Tandem Meetings of ASTCT® and CIBMTR® taking place February 4-7 in Salt Lake City, UT. Clinical data disclosed in November 2025 will be presented with new supportive translational data in a poster presentation on the vispa-cel ANTLER phase 1 clinical trial in relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) and in an oral presentation on the ongoing CB-011 CaMMouflage phase 1 clinical trial in relapsed or refractory multiple myeloma (r/r MM).
AI Summary
Caribou Biosciences announced it will present clinical and new translational data at the 2026 Tandem Meetings of ASTCT® and CIBMTR® (February 4–7, Salt Lake City). Data disclosed in November 2025 will be shown alongside fresh supportive translational analyses: a poster on the vispa-cel (CB-010) ANTLER phase 1 trial in relapsed or refractory B‑cell non‑Hodgkin lymphoma (r/r B‑NHL) and an oral presentation on the CB‑011 CaMMouflage phase 1 trial in relapsed or refractory multiple myeloma (r/r MM).
The ANTLER results indicate vispa-cel produces efficacy and durability comparable to autologous CAR‑T therapy in second‑line large B‑cell lymphoma patients. The CaMMouflage findings link CAR‑T cell expansion to deep, durable responses and support the selected regimen for dose expansion. Together, the clinical and translational data aim to strengthen the rationale for continued development of both programs and inform the next steps in their respective phase 1 dose‑expansion plans.
Read Announcement- Drug:
- CB-011
- Announced Date:
- November 3, 2025
- Indication:
- Allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology.
Announcement
Caribou Biosciences, Inc. announced its first clinical data from dose escalation in the ongoing CaMMouflage phase 1 trial evaluating CB-011, an off-the-shelf anti-BCMA CAR-T cell therapy, in relapsed or refractory multiple myeloma (r/r MM), highlighting CB-011 as a potentially best-in-class allogeneic CAR-T cell therapy for this patient population.
AI Summary
Caribou Biosciences recently shared the first clinical data from its CaMMouflage phase 1 trial testing CB-011, an off-the-shelf CAR-T cell therapy that targets BCMA in patients with relapsed or refractory multiple myeloma. In the dose-escalation portion, escalating doses of CB-011 showed a manageable safety profile, with mostly low-grade cytokine release syndrome and no graft-versus-host disease or severe neurotoxicity observed.
Early signs of anti-tumor activity are encouraging. A number of patients achieved partial or complete responses, and many of these responses have been durable over several months of follow-up. The ability to give CB-011 “off the shelf” means doctors could treat patients more quickly than with traditional, patient-made CAR-T therapies.
These results position CB-011 as a potentially best-in-class allogeneic CAR-T cell treatment for multiple myeloma. Caribou plans to advance CB-011 into further trials to confirm its safety and effectiveness in a larger group of patients.
Read Announcement
CB-010 FDA Regulatory Timeline and Events
CB-010 is a drug developed by Caribou Biosciences for the following indication: Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CB-010
- Announced Date:
- November 3, 2025
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc. announced positive results from its ongoing ANTLER phase 1 clinical trial evaluating vispacabtagene regedleucel (vispa-cel; formerly CB-010), an allogeneic anti-CD19 CAR-T cell therapy, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).
AI Summary
Caribou Biosciences announced promising data from its ANTLER phase 1 trial of vispacabtagene regedleucel (vispa-cel), an off-the-shelf anti-CD19 CAR-T therapy for relapsed or refractory B-cell non-Hodgkin lymphoma. The study shows that a single dose of vispa-cel delivers efficacy and durability on par with approved autologous CAR-T therapies, while offering immediate availability off the shelf.
In the confirmatory cohort (N=22) with partial HLA matching, patients achieved an 82% overall response rate (ORR), a 64% complete response (CR) rate, and 51% progression-free survival (PFS) at 12 months. In 35 patients with an optimized profile, vispa-cel produced an 86% ORR, 63% CR rate, and 53% PFS at one year, with a median follow-up of 11.8 months.
The therapy was generally well tolerated and suitable for outpatient administration, highlighting its potential as a best-in-class allogeneic CAR-T option for large B-cell lymphoma.
Read Announcement- Drug:
- CB-010
- Announced Date:
- November 2, 2025
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc. announced that it will hold a webcast beginning at 8:00 am ET on Monday, November 3, 2025, to report new data from the ANTLER phase 1 clinical trial evaluating vispacabtagene regedleucel (vispa-cel; formerly CB-010), an allogeneic anti-CD19 CAR-T cell therapy, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) and report the first clinical data from the CaMMouflage Phase 1 clinical trial evaluating CB-011, an allogeneic anti-BCMA CAR-T cell therapy, in patients with r/r multiple myeloma.
AI Summary
Caribou Biosciences will host a live webcast at 8:00 am ET on Monday, November 3, 2025, to unveil new findings from its two Phase 1 CAR-T cell therapy trials. Investors, researchers, and physicians can tune in via the Events page on Caribou’s website, with an archived replay available for 30 days.
The company will present updated data from the ANTLER trial of vispacabtagene regedleucel (vispa-cel; formerly CB-010), an allogeneic anti-CD19 CAR-T candidate for patients with relapsed or refractory B-cell non-Hodgkin lymphoma. It will also report the first clinical results from the CaMMouflage trial of CB-011, an allogeneic anti-BCMA CAR-T therapy being tested in patients with relapsed or refractory multiple myeloma.
In addition, Caribou will outline its planned pivotal Phase 3 trial design for vispa-cel and discuss next steps for the ongoing development of CB-011, setting the stage for late-stage studies.
Read Announcement- Drug:
- CB-010
- Announced Date:
- April 24, 2025
- Target Action Date:
- H2 2025
- Estimated Target Date Range:
- July 1, 2025 - December 31, 2025
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc announced a strategic pipeline prioritization with workforce and cost reduction initiatives to focus resources on its lead oncology clinical programs CB-010 and CB-011, with clinical data disclosures now planned for H2 2025.
AI Summary
Caribou Biosciences, Inc. has announced a strategic change to focus on its lead oncology programs, CB-010 and CB-011. The company is implementing workforce and cost reduction initiatives, which include cutting approximately 32% of its staff. This move will allow Caribou to concentrate its resources on advancing its allogeneic CAR-T cell therapies and extend its cash runway by one year, now reaching into the second half of 2027.
Caribou plans to share robust clinical data from CB-010 and CB-011 in the second half of 2025. The data are expected to show promising results in treating large B cell lymphoma and multiple myeloma. This strategy aims to strengthen the company’s position in developing off-the-shelf treatments that offer the potential for broader patient access and improved outcomes in oncology.
Read Announcement- Drug:
- CB-010
- Announced Date:
- March 10, 2025
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc reviewed recent pipeline progress.
AI Summary
Caribou Biosciences, Inc. recently reviewed notable progress in its clinical pipeline. The company is making advances with its off-the-shelf CAR‑T cell therapies for both oncology and autoimmune diseases. Caribou plans to disclose clinical data in the first half of 2025. This includes results from the ANTLER Phase 1 trial of CB-010, aimed at treating second-line large B‑cell lymphoma, where the therapy is designed to match the outcomes of traditional autologous CAR‑T treatments using an HLA matching approach. Additionally, early results from the CaMMouflage Phase 1 trial of CB-011, targeting relapsed or refractory multiple myeloma, have shown encouraging signs of efficacy when paired with a deeper lymphodepletion regimen.
Caribou’s pipeline progress reflects its commitment to improving patient access and treatment availability. The company is rapidly enrolling more patients to strengthen its clinical data as it moves forward with its therapeutic innovations.
Read Announcement- Drug:
- CB-010
- Announced Date:
- January 12, 2025
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc. announced initiation of the GALLOP Phase 1 clinical trial evaluating CB-010 in patients with lupus nephritis (LN) and extrarenal lupus (ERL).
AI Summary
Caribou Biosciences has announced the initiation of its GALLOP Phase 1 clinical trial to evaluate the investigational therapy CB-010 in patients with lupus nephritis and extrarenal lupus. This open-label, multicenter study will assess a single infusion of CB-010 to determine its safety and effectiveness for adults suffering from these types of lupus. The trial represents a significant step forward in Caribou’s efforts to expand its pipeline of innovative therapies using advanced CRISPR genome-editing technology.
The company’s move to launch the GALLOP trial comes as part of its broader strategy to develop treatments that offer rapid and broad access for difficult-to-treat conditions. Caribou Biosciences is committed to advancing research in autoimmune diseases and looks forward to sharing updates as the trial progresses, reinforcing their role at the forefront of cutting-edge therapeutic approaches.
Read Announcement- Drug:
- CB-010
- Announced Date:
- September 25, 2024
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc. announced an abstract has been accepted for a poster presentation at the American College of Rheumatology (ACR) Convergence 2024, which will be held November 14-19, 2024 in Washington, DC.
AI Summary
Caribou Biosciences, Inc., a clinical-stage CRISPR genome-editing company, announced that its abstract has been accepted for a poster presentation at the American College of Rheumatology (ACR) Convergence 2024. The event is scheduled for November 14-19, 2024, in Washington, DC. The poster, titled “Preclinical Analysis of CB-010, an Allogeneic anti-CD19 CAR-T Cell Therapy with a PD-1 Knockout, for the Treatment of Patients with Refractory Systemic Lupus Erythematosus (SLE),” will present preclinical data and key aspects of the clinical trial design that supported the investigational new drug clearance. It will be presented by Dr. Elizabeth Garner, the executive director of T cell therapeutics and translational sciences laboratory, on November 16, 2024, from 10:30 am to 12:30 pm EST at the Walter E. Washington Convention Center.
This presentation underscores Caribou’s commitment to advancing CB-010 through innovative genome-editing strategies and supports its clinical evaluation for challenging autoimmune conditions, including lupus nephritis and extrarenal lupus.
Read Announcement- Drug:
- CB-010
- Announced Date:
- September 3, 2024
- Target Action Date:
- LATE 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc. CB-010 GALLOP Phase 1 trial in patients with LN and ERL is on track to initiate by YE 2024
AI Summary
Caribou Biosciences announced that its CB-010 GALLOP Phase 1 clinical trial, targeting lupus nephritis (LN) and extrarenal lupus (ERL), is on track to begin by the end of 2024. This trial will evaluate the safety and effectiveness of CB-010, an allogeneic anti-CD19 CAR-T cell therapy, for patients suffering from these severe manifestations of systemic lupus erythematosus (SLE). The study is designed to address significant unmet medical needs in patients who have limited treatment options due to the complexity of their disease. Caribou Biosciences is committed to advancing innovative off-the-shelf cell therapies, using cutting-edge CRISPR technology to potentially improve outcomes. The initiation of this GALLOP trial marks an important step in their efforts to deliver novel treatments to patients with LN and ERL, highlighting the company’s focus on providing transformative solutions for challenging autoimmune conditions.
Read Announcement- Drug:
- CB-010
- Announced Date:
- September 3, 2024
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designations to CB-010 for refractory systemic lupus erythematosus (SLE)
AI Summary
Caribou Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational therapy CB-010 for refractory systemic lupus erythematosus (SLE). This designation is aimed at speeding up the clinical development and regulatory review process for promising treatments addressing serious conditions. CB-010 is an allogeneic anti-CD19 CAR-T cell therapy that targets severe forms of SLE, particularly lupus nephritis (LN) and extrarenal lupus (ERL). The accelerated timeline provided by the Fast Track status could help bring this innovative therapy to patients with unmet medical needs more quickly. The GALLOP Phase 1 clinical trial for CB-010 is on track to begin by the end of 2024, marking a crucial step in expanding treatment options for individuals suffering from this challenging autoimmune disease.
Read Announcement- Drug:
- CB-010
- Announced Date:
- June 2, 2024
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc. today presented updated clinical data from the ongoing ANTLER Phase 1 trial that indicates a single dose of CB-010, a readily available, off-the-shelf anti-CD19 CAR-T cell therapy with a PD-1 knockout, has the potential to rival the safety, efficacy, and durability of approved autologous CAR-T cell therapies.
AI Summary
Caribou Biosciences recently presented updated data from their ongoing ANTLER Phase 1 trial, highlighting the potential of CB-010—a ready-to-use, off-the-shelf anti-CD19 CAR-T cell therapy with a PD-1 knockout—to match the safety, efficacy, and durability of approved autologous CAR-T treatments. Notably, the trial results show that patients receiving partially HLA matched CB-010 (with ≥4 matching alleles) achieved a median progression-free survival of 14.4 months, compared to only 2.8 months for those with lower matching. This finding suggests that partial HLA matching may play a critical role in enhancing patient outcomes. Building on these promising insights, Caribou plans to enroll approximately 20 more patients with second-line large B cell lymphoma to further validate the results. Initial data from this cohort is expected in the first half of 2025, and a pivotal Phase 3 trial is planned thereafter.
Read Announcement
CB-012 FDA Regulatory Events
CB-012 is a drug developed by Caribou Biosciences for the following indication: For the Treatment of Relapsed or Refractory Acute Myeloid Leukemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CB-012
- Announced Date:
- September 3, 2024
- Indication:
- For the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Announcement
Caribou Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CB-012 for relapsed or refractory acute myeloid leukemia (r/r AML).
AI Summary
Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its CB-012 therapy, which is being developed to treat patients with relapsed or refractory acute myeloid leukemia (r/r AML). This designation is designed to speed up the clinical development and regulatory review process, helping to bring new, promising treatments to patients sooner. CB-012 is an allogeneic anti-CLL-1 CAR-T cell therapy that uses advanced CRISPR technology. Currently, it is under evaluation in the ongoing AMpLify Phase 1 clinical trial, where dose escalation studies are taking place. The Fast Track status highlights the potential of CB-012 to address an urgent need, as many AML patients either do not respond to existing treatments or quickly relapse after receiving them.
Read Announcement
