Clinical trial NCT06885424: A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2 Bio) Gene Therapy (GT) Products
Official title: A Long-Term Follow-Up Study of Participants Treated With A2 Biotherapeutics (A2Bio) Gene Therapy (GT) Products
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Solid Tumor Cancer
Solid Tumor, Unspecified, Adult
Colorectal Carcinoma
Colorectal Carcinoma (CRC)
Non Small Cell Lung Cancer
Small Cell Lung Cancer ( SCLC )
Pancreatic Cancer
NSCLC
Mesothelioma
Ovarian Cancer
Ovarian Carcinoma
Head and Neck (HNSCC)
Head and Neck Cancer
Renal Cell Carcinoma (Kidney Cancer)
Triple Negative Breast Cancer (TNBC)
Keywords: CAR T Cell Therapy
Gene Therapy
Lead sponsor: A2 Biotherapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants previously treated on a A2 Bio GT study

Brief summary: This protocol is to ensure consistent long-term follow-up for delayed safety events in participants who received A2 Bio gene therapy (GT) products.

Detailed description: This is a long-term follow-up study designed to evaluate delayed safety events and long-term efficacy of A2 Bio GT products for participants who received any amount of A2 Bio GT products in a previous interventional study. No further interventional treatment is administered in this study.

Participants will enroll in this long-term follow-up study upon completion of 2 years of follow-up in the assigned interventional study in which they received treatment. Participants will be followed for up to 15 years after administration of A2 Bio GT product. This study will collect long-term safety and efficacy data as outlined by the FDA guidance for long-term follow-up for GT products.

Eligibility criteria: Inclusion Criteria:

1. Received any amount of A2 Bio GT product on a previous A2 Bio interventional study
2. Able to provide written informed consent for this long-term follow-up study
3. Able to comply with study requirements

Exclusion Criteria:

1. There are no specific exclusion criteria for this study

Primary outcomes:
measure: Long-term safety of previous A2 Bio GT treatment
timeFrame: 15 years post treatment with A2 Bio GT product
Secondary outcomes:
measure: Overall survival
timeFrame: 15 years post treatment with A2 Bio GT product
measure: Long-term durability of clinical effect of previous A2 Bio GT treatment
timeFrame: 15 years post treatment with A2 Bio GT product
measure: Progression Free Survival (PFS)
timeFrame: 15 years post treatment with A2 Bio GT product
measure: Incidence of RCL detected in blood
timeFrame: 15 years post treatment with A2 Bio GT product
Other outcomes:
measure: Progression Free Survival 2 (PFS2)
timeFrame: 15 years post treatment with A2 Bio GT product
measure: Persistence of of A2 Bio GT
timeFrame: 5 years post treatment with A2 Bio GT product
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: A2 Biotherapeutics
name: Eric Ng, MD
role: STUDY_DIRECTOR
References: