8-K - Caribou Biosciences, Inc. | StockGist

AI Analysis

AI-generated analysis. Always verify with the original filing.

Caribou Biosciences received FDA RMAT designation for CB-011 allogeneic anti-BCMA CAR-T therapy in r/r multiple myeloma based on promising phase 1 dose escalation data showing 92% ORR in BCMA-naïve patients.

Key Takeaways

1FDA granted RMAT designation to CB-011 for r/r MM, enabling expedited development and potential priority review.

2Phase 1 CaMMouflage trial dose escalation: 92% ORR, 75% ≥CR rate, 91% MRD negativity in 12 BCMA-naïve patients at 450x10^6 dose (RDE).

3Ongoing dose expansion enrollment in BCMA-naïve and BCMA-exposed cohorts; additional data expected in 2026.

4Manageable safety profile with no GvHD, IECAE, parkinsonism, or cranial nerve palsies observed.

5CB-011 also has FDA Fast Track and Orphan Drug designations for r/r MM.

Current Report Details

Event Type

Regulation Fd

Other Event

Exhibits Only

Disclosure

Voluntary

Variant

8-K

Items Reported

7.01

. The information in this Item 7.01, including the accompanying Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange

Regulation Fd

8.01

Other Events. On March 31, 2026, the Company announced that it received RMAT designation for r/r MM from the FDA for CB-011, its allogeneic anti-BCMA CAR-T cell

Other Event

9.01

Financial Statements and Exhibits. (d) Exhibits Exhibit No.: 99.1 | Description: Press Release Issued by Caribou Biosciences, Inc. on March 31, 2026 Exhibit No.

Exhibits Only

Source Document

Exhibits (2)

8-K

99.1

EX-99.1