---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-114841"
form_type: "8-K"
ticker: "CGEM"
cik: "0001789972"
company_name: "Cullinan Therapeutics, Inc."
filed_at: "2024-10-16T23:59:59+00:00"
generated_at: "2026-05-30T13:55:24.957754+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Cullinan Therapeutics receives FDA IND clearance for CLN-978 in moderate-to-severe SLE

## Summary
- FDA cleared IND for CLN-978, a CD19 T cell engager, in systemic lupus erythematosus.
- Phase 1 trial will enroll patients with SLEDAI score ≥8 and inadequate response to ≥2 prior treatments.
- Starting dose 10 mcg; Part A dose escalation, Part B dose expansion with multiple schedules.
- First development-stage CD19 T cell engager to receive FDA IND clearance in autoimmune diseases.
- Global trial already cleared in Australia (NCT06613360); U.S. enrollment now allowed.

## SEC filing metadata
- accession: 0000950170-24-114841
- form_type: 8-K
- ticker: CGEM
- cik: 0001789972
- company_name: Cullinan Therapeutics, Inc.
- filed_at: 2024-10-16T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1789972/000095017024114841/0000950170-24-114841-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1789972/000095017024114841/cgem-20241016.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-114841
- JSON: https://secwatch.observer/filing/0000950170-24-114841.json
- Plain text: https://secwatch.observer/filing/0000950170-24-114841.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.