Solid Tumor, Adult study: A2B395
Official title A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
ClinicalTrials.gov ID: NCT06682793
What this study is testing
What is A2B395?
An investigational allogeneic CAR T‑cell therapy being studied for solid tumors such as colorectal, lung, head and neck, breast, and kidney cancers. It is designed to target cells that express EGFR while sparing healthy cells that retain HLA‑A02, using a logic‑gated Tmod CAR construct.
Also referred to as Tmod CAR T‑cell Therapy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the recommended dose of A2B395 is safe and can kill tumor cells while protecting healthy cells.
- Who it's for
- You may be able to join if you are an adult with a solid tumor that shows EGFR and has lost HLA‑A*02.
- What's involved
- You will get a pre‑treatment that lowers immune cells, then an infusion of A2B395 CAR T cells. You will attend study visits and have tests.
- Time commitment
- The study lasts several months and includes the infusion day plus multiple follow‑up visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\ 02 by NGS (whenever possible from...
- Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR...
- Received previous required therapy for the appropriate solid tumor disease as described in the protocol
- Has adequate organ function as described in the protocol
- ECOG performance status of 0 to 1
You likely can't join if
- Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion
- Radiotherapy within 28 days of A2B395 infusion
- Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
See the full eligibility criteria
- Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\ 02 by NGS (whenever possible from the primary site).
- Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.
- Received previous required therapy for the appropriate solid tumor disease as described in the protocol
- Has adequate organ function as described in the protocol
- ECOG performance status of 0 to 1
- Life expectancy of ≥3 months
- Willing to comply with study schedule of assessments including long-term safety follow-up Key
- Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion
- Radiotherapy within 28 days of A2B395 infusion
- Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
- Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment.
- History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year
- Requires supplemental home oxygen
- Females of childbearing potential who are pregnant or breastfeeding
- people, 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 A2B395
The study team makes the final eligibility decision.
Where it is enrolling
- Gilbert, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Tampa, Florida, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Gilbert, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Jacksonville, Florida, United States; Tampa, Florida, United States; Rochester, Minnesota, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.