Clinical Trials

Key Inclusion Criteria:

1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A*02:01 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy.

2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, or other solid tumors associated with CEA expression. Measurable disease is required with lesions of >1.0 cm by computed tomography (CT). (Soluble CEA is not acceptable as the sole measure of disease).

3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol.

4. Has adequate organ function as described in the protocol.

5. ECOG performance status of 0 to 1.

6. Life expectancy of ≥ 3 months.

7. Willing to comply with study schedule of assessments including long term safety follow up.

Key Exclusion Criteria:

1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative.

2. Prior allogeneic stem cell transplant.

3. Prior solid organ transplant.

4. Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion.

5. Radiotherapy within 28 days of A2B530 infusion.

6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months.

7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of
PE or DVT if greater than 3 months from time of enrollment, and adequately treated.

8. Requires supplemental home oxygen.

9. Females of childbearing potential who are pregnant or breastfeeding.

10. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B530.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/3/23. Questions regarding updates should be directed to the study team contact.