Our RESETTM clinical trials with CABA-201 (investigational CD19-CAR T cell therapy) in lupus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris are now recruiting.
Cabaletta Bio., Inc. – Expanded Access Policy
As a clinical-stage company, we are focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. We understand that there may be circumstances under which patients or caregivers may request treatment with our investigative therapies before approval by regulatory agencies. This is sometimes called “expanded access,” “compassionate use,” or “early access.” We use the term “expanded access” to capture all of these.
Participation in clinical trials is the most common way to access investigational therapies. Clinical trials ensure that the safety and efficacy of the investigational therapy are evaluated prior to submission for review and potential approval by regulatory authorities. Therefore, after careful consideration, Cabaletta has decided that the best way for patients to access our investigational therapies is through clinical trial participation. As a result, we will not offer expanded access for our investigational therapies at this time.
- Contact Information. If you have any questions about Cabaletta’s expanded access policy, please contact ClinicalTrials@cabalettabio.com.
- Request Procedures. Although Cabaletta is not planning to make its investigational therapies available on an expanded access basis at this time, if you would like to submit an expanded access request, please feel free to submit sufficient supporting detail to enable Cabaletta to evaluate your request. Please also include your contact information so that Cabaletta may follow-up with you directly.
- General Criteria. Cabaletta is not making its investigational therapies available on an expanded access basis at this time. In the event that Cabaletta decides to consider expanded access requests in the future, Cabaletta will evaluate and respond to each expanded access request on a case-by-case basis.
- Anticipated Timing. Cabaletta anticipates acknowledging receipt of any expanded access questions or requests within seven (7) business days of receipt. As noted above, Cabaletta is not making its investigational therapies available on an expanded access basis at this time.
- Clinicaltrials.gov Hyperlink. Cabaletta is not currently making its investigational therapies available for expanded access use. In the event that Cabaletta decides to make Cabaletta’s therapies available on an expanded access basis, this policy will be updated with a hyperlink to the relevant expanded access record(s) on clinicaltrials.gov after such records become active.
As authorized by the 21st Century Cures Act, Cabaletta may revise this expanded access policy at any time. Additionally, the posting of this policy by Cabaletta shall not serve as a guarantee of access to any specific investigational therapy by any individual patient.