Engineered immune cells take on Hard-to-Treat cancers
NCT ID NCT06682793
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests A2B395, a donor-derived CAR T-cell therapy designed to target cancer cells while sparing healthy ones. It is for adults with advanced solid tumors like colorectal, lung, or breast cancer that have lost a specific immune marker. The trial has two phases: first to find a safe dose, then to see if it shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A2B395 (a type of CAR T-cell therapy made from donor cells)
- What this could lead to
- If successful, this could provide a new treatment option for several hard-to-treat cancers that have stopped responding to standard therapies.
- What could go wrong
- This is an early-phase trial (Phase 1/2) with only 240 participants, so the treatment may not work or could cause serious side effects like cytokine release syndrome or graft-versus-host disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Key Inclusion Criteria: 1. 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). 2. 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. 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 A2B395 infusion 5. Radiotherapy within 28 days of A2B395 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. 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 9. Requires supplemental home oxygen 10. Females of childbearing potential who are pregnant or breastfeeding 11. 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 A2B395
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Banner MD Anderson Cancer Center
RECRUITINGGilbert, Arizona, 85234, United States
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Fred Hutch Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Moffitt Cancer Center
RECRUITINGTampa, Florida, 33606, United States
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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UCLA Medical Center
RECRUITINGLos Angeles, California, 90404, United States
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UCSD Moores Cancer Center
RECRUITINGLa Jolla, California, 92093, United States
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Washington University
RECRUITINGSt Louis, Missouri, 63110, United States
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