Cullinan Therapeutics Inc. (Nasdaq: CGEM) has received U.S. and Australian regulatory clearance to begin a global Phase 1b/2a trial of velinotamig in adults with relapsing or treatment-resistant autoimmune blood disorders.
The open-label, multicenter study will evaluate velinotamig in immune thrombocytopenia, or ITP, and warm autoimmune hemolytic anemia, known as wAIHA. FDA clearance of the Investigational New Drug application permits the U.S. trial to proceed but does not constitute approval of the treatment.
ITP causes the immune system to destroy platelets and can produce bruising, fatigue and potentially serious bleeding. In wAIHA, autoantibodies prematurely destroy red blood cells, causing anemia, shortness of breath, jaundice and other complications.
Velinotamig, also known as CLN-803 and GR1803, is an investigational BCMAxCD3 T-cell engager. It is designed to redirect cytotoxic T cells toward BCMA-expressing plasma cells, including the cells that produce disease-causing autoantibodies.
The trial will administer a defined course of four subcutaneous doses. Its Phase 1b portion will test multiple ascending doses, while the Phase 2a portion will evaluate selected regimens in separate ITP and wAIHA expansion groups. The primary objectives include safety, tolerability and effects on disease activity.
“ITP and wAIHA are compelling settings for which targeting antibody-producing plasma cells with a defined course of velinotamig may deliver durable clinical benefit,” Chief Medical Officer Jeffrey Jones said.
That potential has not yet been demonstrated in either disease. The trial is open-label and begins with early-stage dose exploration, meaning initial findings will primarily establish safety and help determine an appropriate regimen for further testing.
Cullinan holds exclusive rights to develop and commercialize velinotamig outside Greater China through a licensing agreement with Genrix Bio. Genrix is separately studying the candidate in patients with refractory systemic lupus erythematosus in China and is scheduled to present updated data at the American College of Rheumatology Convergence on November 8.
Those results could provide additional information about BCMA-directed plasma-cell depletion, but they will involve a different autoimmune condition and cannot establish that velinotamig will work in ITP or wAIHA.
The development field is also competitive. Other biotechnology companies, including Regeneron Pharmaceuticals, Candid Therapeutics and Ouro Medicines, are evaluating BCMA-directed T-cell engagers in autoimmune diseases.
Cullinan reported $334.5 million in cash, cash equivalents and short-term investments as of June 30, 2026, along with $21.4 million in long-term investments and interest receivable. Its second-quarter net loss was $53.7 million.
The company used $84.3 million in operating cash during the first six months of 2026 and reported an accumulated deficit of $691.5 million. Cullinan also maintains an at-the-market program allowing it to sell up to $200 million in common stock, creating potential dilution if utilized.
Upcoming Catalysts
- Confirmation of initial patient dosing and enrollment
- Dose-escalation safety and pharmacodynamic findings
- Selection of regimens for the Phase 2a expansion groups
- Genrix Bio’s lupus data presentation on November 8
- Preliminary clinical-activity data in ITP and wAIHA
Sources
- Cullinan receives regulatory clearance for the velinotamig trial — October 27, 2026
- Velinotamig Phase 1b/2a trial record, NCT07738822 — ClinicalTrials.gov
- Cullinan Therapeutics second-quarter 2026 results — SEC
- Cullinan Therapeutics Form 10-Q for the quarter ended June 30, 2026 — SEC
Editorial Disclosure
This article is based entirely on publicly available information, including company announcements, SEC filings and the federal clinical-trial registry. Securities discussed or referenced include Cullinan Therapeutics Inc. (Nasdaq: CGEM). Biotech Stocks Daily has not received compensation from any company mentioned, its management, investor relations representatives or any third party for this specific article. Biotech Stocks Daily may have current or past paid business relationships with other companies, which do not influence the content or conclusions of this article. No staff member or principal of Biotech Stocks Daily holds a position in any security mentioned at the time of publication.
Sources used include Cullinan Therapeutics’ October 27, 2026 regulatory announcement, ClinicalTrials.gov and the company’s second-quarter results and Form 10-Q. Information concerning velinotamig’s mechanism, development potential and planned clinical program originated primarily from Cullinan and has not been independently validated by Biotech Stocks Daily.
Velinotamig remains investigational and has not been approved by the FDA, the Australian Therapeutic Goods Administration or another regulatory authority. Regulatory clearance permits the clinical study to proceed but does not establish safety or efficacy. The open-label Phase 1b/2a trial may encounter enrollment, safety, manufacturing or regulatory delays, and early results may not support later-stage development.
Financial information reflects Cullinan’s position as of June 30, 2026. The company has a history of operating losses, reported an accumulated deficit of $691.5 million and expects continued losses. Its at-the-market equity program could dilute existing shareholders if additional shares are sold.
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