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-010 and CB-012. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- April 24, 2025
- Estimated Event Date Range:
- July 1, 2025 - December 31, 2025
- Target Action Date:
- 2025-H2
- 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
- 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:
- September 3, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-LATE
- 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:
- 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- Drug:
- CB-010
- Announced Date:
- April 4, 2024
- Estimated Event Date Range:
- April 1, 2024 - June 30, 2024
- Target Action Date:
- Q2 - 2024
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc. announced that initial dose expansion data to be shared at a medical congress in Q2 2024
AI Summary
Caribou Biosciences, Inc. announced that they will share initial dose expansion data from the ongoing ANTLER Phase 1 trial at a medical congress in Q2 2024. This trial targets patients with second-line large B cell lymphoma (LBCL) and follows promising safety and early efficacy results observed during the dose escalation phase in relapsed or refractory B-cell non-Hodgkin lymphoma. The upcoming presentation is expected to provide more details on the performance of their innovative, off-the-shelf CAR-T cell therapy, which uses CRISPR genome-editing technology designed to improve treatment outcomes. By advancing this approach, Caribou aims to offer new and effective therapeutic options, potentially addressing unmet needs in patients with aggressive lymphoma.
Read Announcement- Drug:
- CB-010
- Announced Date:
- April 4, 2024
- Indication:
- Relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL
Announcement
Caribou Biosciences, Inc announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout (KO), for the treatment of lupus nephritis (LN) and extrarenal lupus (ERL). .
AI Summary
Caribou Biosciences has received FDA clearance for its Investigational New Drug (IND) application for CB-010, an allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knockout. This treatment is designed to target CD19-positive B cells that drive the autoimmune response in lupus by producing harmful autoantibodies. Caribou plans to expand the application of CB-010 to treating lupus nephritis (LN) and extrarenal lupus (ERL), two severe manifestations of lupus.
The therapy aims to reduce T cell exhaustion and improve safety by utilizing a PD-1 knockout, potentially offering better outcomes compared to current treatments. The GALLOP Phase 1 trial, an open-label and multicenter study, is expected to begin by the end of 2024. Caribou Biosciences is optimistic that CB-010 could significantly enhance the treatment options available for lupus patients by providing an off-the-shelf, effective therapy.
Read Announcement
CB-012 - FDA Regulatory Timeline and 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
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