Solid Tumor, AdultPhase 1/2DENALI-1NCT06682793
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
A Phase 1/2 study testing A2B395 and xT CDx with HLA-LOH assay in people with Solid Tumor, Adult and Colorectal Cancer, run by A2 Biotherapeutics Inc. at 10 sites in United States.
Trial summary
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Colorectal Cancer, Non-Small Cell Lung
- What is being tested?
- A2B395 and xT CDx with HLA-LOH assay
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 10 sitesUnited States
- Study dates
- 22 May 2025to 31 Mar 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
- 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
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Cindi Jenkins, Cynthia.Jenkins@osumc.edu
Kai He, MD, PhD
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Kylie Ketchum, kylie.ketchum@bannerhealth.com
Matthew Ulrickson, MD
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015
Yanyan Lou, MD
- Recruiting
UCSD Moores Cancer Center
La Jolla, California, 92093
Jona Plevin, jplevin@health.ucsd.edu
Rebecca Shatsky, rshatshy@health.ucsd.edu
- Recruiting
UCLA Medical Center
Los Angeles, California, 90404
Lisa Del Rio, ldelrio@mednet.ucla.edu
Deborah Wong, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
# Phase1Screening, #phase1screening@nyulangone.org
Salman Punekar, MD, Salman.punekar@nyulangone.org
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015
Harry E. Fuentes Bayne, MD
- Recruiting
Fred Hutch Cancer Center
Seattle, Washington, 98109
Shelby Colden, scolden2@fredhutch.org
Jennifer Specht, MD
- Recruiting
Washington University
St Louis, Missouri, 63110
Amberly Scott, amberly@wustl.edu
Patrick Grierson, M.D., Ph.D.
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33606
Gillian Zankel, Gillian.Zankel@moffitt.org
Kedar Kirtane, MD
About this study
Official title: A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A*02 expression.
The main questions this study aims to answer are:
Read more
- Phase 1: What is the recommended dose of A2B395 that is safe for patients
- Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
- Enrollment in BASECAMP-1 (NCT04981119)
- Preconditioning lymphodepletion (PCLD) regimen
- A2B395 Tmod CAR T cells at the assigned dose
Read the detailed description
This is a seamless phase 1/2, multi-center, open-label study that enrolls adults with recurrent unresectable, locally advanced, or metastatic (considered non-curative) CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Subjects must be germline HLA-A*02 heterozygous, with tumors that express EGFR and have lost HLA-A*02 expression. The purpose of Phase 1 of this study is to determine the safety and the optimal dose of A2B395 (after PCLD) in participants with solid tumor disease. The purpose of Phase 2 of this study is to determine the further safety and efficacy (how well it treats the solid tumor disease) of A2B395.
The treatment available for these cancers and other solid tumors can be toxic, debilitating, and fatal. In the recurrent unresectable, locally advanced, or metastatic setting, the intent of standard of care treatment is typically palliative rather than curative, and has not changed significantly in several decades. A2 Bio hypothesizes that A2B395 Tmod CAR T-cell therapy will enable the killing of tumor target cells (those cells that express EGFR and have loss of heterozygosity [LOH] for the HLA-A*02 protein). Additionally, normal healthy cells that maintain HLA-A*02 expression and co-express EGFR (eg, skin tissue) will not be targeted due to the blocker portion of the Tmod CAR T cell that acts as a self-regulated safety switch that protects normal tissue from damage. Furthermore, the blocker portion of the Tmod CAR T cell will act as a safety switch to protect normal tissue from graft versus host disease (GvHD) that could be caused by an allogeneic CAR T cell. A2 Bio intends this to provide a wider therapeutic safety window compared to previous solid tumor targeting therapies. This hypothesis will be explored in the study.
Participants for this study must enroll and have confirmation of LOH in the pre-screening BASECAMP-1 study (NCT04981119). Upon disease progression the participant may screen for this study (DENALI-1). There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to DENALI-1 based on their own disease course.
- Conditions
- Solid Tumor, Adult, Colorectal Cancer, Non-Small Cell Lung, NSCLC (Non-small Cell Lung Cancer), Cancer, Colon Cancer
- Being tested
- A2B395, xT CDx with HLA-LOH assay
- Keywords
- CAR T Cell, Solid Tumors, Allogeneic, T Cell, EGFR, HLA-A2, Solid tumors expressing EGFR, CRC, Colorectal, Cell Therapy, Gene Therapy, Blocker, Cancer, NSCLC, Non small Cell Lung Cancer, Lung Cancer, renal cell carcinoma, RCC, Kidney Cancer, Renal cell cancer
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Lung Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A2B395Biological
Also called Tmod CAR T-cell Therapy
Allogeneic logic-gated Tmod CAR T cells
xT CDx with HLA-LOH assayDiagnostic test
An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device
| Study group | Role | What they receive |
|---|---|---|
| A2B395 | Experimental | Participants receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B395 intravenously on day 0 Receives: Biological: A2B395; Diagnostic Test: xT CDx with HLA-LOH assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level
Adverse events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or current version). Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and graft versus host disease (GvHD) events will be graded according to the criteria described in the current protocol.
Measured: From the time of Informed consent until 24 months (2 years) post A2B395 infusion
Phase 1: Recommended phase 2 dose (RP2D)
The RP2D will be identified utilizing a BOIN study design in addition to considering safety and biomarker analysis.
Measured: 28 days post A2B395 infusion
Phase 2: The overall response rate (ORR) for patients
The ORR will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and assessed by independent central review.
Measured: 24 months post A2B395 infusion
Secondary outcomes (3)
Persistence of A2B395
Number of A2B395 Tmod CAR T cells present in participants treated with A2B395 as assessed by polymerase chain reaction (PCR) (or similar method) on participant blood samples
Measured: up to 24 months post A2B395 infusion
Cytokine analysis
Cytokine levels such as interferon-gamma (IFN-γ) in participants treated with A2B395 assessed by cytokine analysis on participant blood samples
Measured: up to 24 months post A2B395 infusion
Cytokine analysis
Cytokine levels such as interleukin-6 (IL-6) in participants treated with A2B395 assessed by cytokine analysis on participant blood samples
Measured: up to 24 months post A2B395 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start22 May 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A2 Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Welch, MD, PhD, Study director, A2 Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682793
- Sponsor's protocol ID
- A2B395-101
- Acronym
- DENALI-1
- Status last verified
- Sep 2025
- First submitted
- 7 Nov 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study data will be shared within 1 year of study completion.
Publications
DiAndreth B, Hamburger AE, Xu H, Kamb A. The Tmod cellular logic gate as a solution for tumor-selective immunotherapy. Clin Immunol. 2022 Aug;241:109030. doi: 10.1016/j.clim.2022.109030. Epub 2022 May 11.
PubMed 35561999Oh J, Kirsh C, Hsin JP, Radecki KC, Zampieri A, Manry D, Ando Y, Miller S, Chan J, McLeod E, Cunningham KM, Wong LM, Xu H, Kamb A. NOT gated T cells that selectively target EGFR and other widely expressed tumor antigens. iScience. 2024 May 7;27(6):109913. doi: 10.1016/j.isci.2024.109913. eCollection 2024 Jun 21.
PubMed 38799557Beroukhim R, Mermel CH, Porter D, Wei G, Raychaudhuri S, Donovan J, Barretina J, Boehm JS, Dobson J, Urashima M, Mc Henry KT, Pinchback RM, Ligon AH, Cho YJ, Haery L, Greulich H, Reich M, Winckler W, Lawrence MS, Weir BA, Tanaka KE, Chiang DY, Bass AJ, Loo A, Hoffman C, Prensner J, Liefeld T, Gao Q, Yecies D, Signoretti S, Maher E, Kaye FJ, Sasaki H, Tepper JE, Fletcher JA, Tabernero J, Baselga J, Tsao MS, Demichelis F, Rubin MA, Janne PA, Daly MJ, Nucera C, Levine RL, Ebert BL, Gabriel S, Rustgi AK, Antonescu CR, Ladanyi M, Letai A, Garraway LA, Loda M, Beer DG, True LD, Okamoto A, Pomeroy SL, Singer S, Golub TR, Lander ES, Getz G, Sellers WR, Meyerson M. The landscape of somatic copy-number alteration across human cancers. Nature. 2010 Feb 18;463(7283):899-905. doi: 10.1038/nature08822.
PubMed 20164920Hwang MS, Mog BJ, Douglass J, Pearlman AH, Hsiue EH, Paul S, DiNapoli SR, Konig MF, Pardoll DM, Gabelli SB, Bettegowda C, Papadopoulos N, Vogelstein B, Zhou S, Kinzler KW. Targeting loss of heterozygosity for cancer-specific immunotherapy. Proc Natl Acad Sci U S A. 2021 Mar 23;118(12):e2022410118. doi: 10.1073/pnas.2022410118.
PubMed 33731480Hamburger AE, DiAndreth B, Cui J, Daris ME, Munguia ML, Deshmukh K, Mock JY, Asuelime GE, Lim ED, Kreke MR, Tokatlian T, Kamb A. Engineered T cells directed at tumors with defined allelic loss. Mol Immunol. 2020 Dec;128:298-310. doi: 10.1016/j.molimm.2020.09.012. Epub 2020 Oct 1.
PubMed 33012527
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
- ClinicalTrials.gov ID
- NCT06682793
- Acronym / sponsor ID
- DENALI-1 / A2B395-101
- Conditions
- Solid Tumor, Adult, Colorectal Cancer, Non-Small Cell Lung, NSCLC (Non-small Cell Lung Cancer), Cancer, Colon Cancer
- Keywords
- CAR T Cell, Solid Tumors, Allogeneic, T Cell, EGFR, HLA-A2, Solid tumors expressing EGFR, CRC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- A2 Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A*02 expression.
The main questions this study aims to answer are:
- Phase 1: What is the recommended dose of A2B395 that is safe for patients
- Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
- Enrollment in BASECAMP-1 (NCT04981119)
- Preconditioning lymphodepletion (PCLD) regimen
- A2B395 Tmod CAR T cells at the assigned dose
Detailed description
This is a seamless phase 1/2, multi-center, open-label study that enrolls adults with recurrent unresectable, locally advanced, or metastatic (considered non-curative) CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Subjects must be germline HLA-A*02 heterozygous, with tumors that express EGFR and have lost HLA-A*02 expression. The purpose of Phase 1 of this study is to determine the safety and the optimal dose of A2B395 (after PCLD) in participants with solid tumor disease. The purpose of Phase 2 of this study is to determine the further safety and efficacy (how well it treats the solid tumor disease) of A2B395.
The treatment available for these cancers and other solid tumors can be toxic, debilitating, and fatal. In the recurrent unresectable, locally advanced, or metastatic setting, the intent of standard of care treatment is typically palliative rather than curative, and has not changed significantly in several decades. A2 Bio hypothesizes that A2B395 Tmod CAR T-cell therapy will enable the killing of tumor target cells (those cells that express EGFR and have loss of heterozygosity [LOH] for the HLA-A*02 protein). Additionally, normal healthy cells that maintain HLA-A*02 expression and co-express EGFR (eg, skin tissue) will not be targeted due to the blocker portion of the Tmod CAR T cell that acts as a self-regulated safety switch that protects normal tissue from damage. Furthermore, the blocker portion of the Tmod CAR T cell will act as a safety switch to protect normal tissue from graft versus host disease (GvHD) that could be caused by an allogeneic CAR T cell. A2 Bio intends this to provide a wider therapeutic safety window compared to previous solid tumor targeting therapies. This hypothesis will be explored in the study.
Participants for this study must enroll and have confirmation of LOH in the pre-screening BASECAMP-1 study (NCT04981119). Upon disease progression the participant may screen for this study (DENALI-1). There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to DENALI-1 based on their own disease course.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A2B395 | Experimental | Biological: A2B395, Diagnostic Test: xT CDx with HLA-LOH assayParticipants receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B395 intravenously on day 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A2B395Also: Tmod CAR T-cell TherapyAllogeneic logic-gated Tmod CAR T cells | Biological | A2B395 |
| xT CDx with HLA-LOH assayAn investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device | Diagnostic test | A2B395 |
Primary outcome
Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level
Time frame: From the time of Informed consent until 24 months (2 years) post A2B395 infusion
Adverse events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or current version). Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and graft versus host disease (GvHD) events will be graded according to the criteria described in the current protocol.
Phase 1: Recommended phase 2 dose (RP2D)
Time frame: 28 days post A2B395 infusion
The RP2D will be identified utilizing a BOIN study design in addition to considering safety and biomarker analysis.
Phase 2: The overall response rate (ORR) for patients
Time frame: 24 months post A2B395 infusion
The ORR will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and assessed by independent central review.
3 secondary outcomes
Persistence of A2B395
Time frame: up to 24 months post A2B395 infusion
Cytokine analysis
Time frame: up to 24 months post A2B395 infusion
Cytokine analysis
Time frame: up to 24 months post A2B395 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 35561999DiAndreth B, Hamburger AE, Xu H, Kamb A. The Tmod cellular logic gate as a solution for tumor-selective immunotherapy. Clin Immunol. 2022 Aug;241:109030. doi: 10.1016/j.clim.2022.109030. Epub 2022 May 11.
- Background: PubMed 38799557Oh J, Kirsh C, Hsin JP, Radecki KC, Zampieri A, Manry D, Ando Y, Miller S, Chan J, McLeod E, Cunningham KM, Wong LM, Xu H, Kamb A. NOT gated T cells that selectively target EGFR and other widely expressed tumor antigens. iScience. 2024 May 7;27(6):109913. doi: 10.1016/j.isci.2024.109913. eCollection 2024 Jun 21.
- Background: PubMed 20164920Beroukhim R, Mermel CH, Porter D, Wei G, Raychaudhuri S, Donovan J, Barretina J, Boehm JS, Dobson J, Urashima M, Mc Henry KT, Pinchback RM, Ligon AH, Cho YJ, Haery L, Greulich H, Reich M, Winckler W, Lawrence MS, Weir BA, Tanaka KE, Chiang DY, Bass AJ, Loo A, Hoffman C, Prensner J, Liefeld T, Gao Q, Yecies D, Signoretti S, Maher E, Kaye FJ, Sasaki H, Tepper JE, Fletcher JA, Tabernero J, Baselga J, Tsao MS, Demichelis F, Rubin MA, Janne PA, Daly MJ, Nucera C, Levine RL, Ebert BL, Gabriel S, Rustgi AK, Antonescu CR, Ladanyi M, Letai A, Garraway LA, Loda M, Beer DG, True LD, Okamoto A, Pomeroy SL, Singer S, Golub TR, Lander ES, Getz G, Sellers WR, Meyerson M. The landscape of somatic copy-number alteration across human cancers. Nature. 2010 Feb 18;463(7283):899-905. doi: 10.1038/nature08822.
- Background: PubMed 33731480Hwang MS, Mog BJ, Douglass J, Pearlman AH, Hsiue EH, Paul S, DiNapoli SR, Konig MF, Pardoll DM, Gabelli SB, Bettegowda C, Papadopoulos N, Vogelstein B, Zhou S, Kinzler KW. Targeting loss of heterozygosity for cancer-specific immunotherapy. Proc Natl Acad Sci U S A. 2021 Mar 23;118(12):e2022410118. doi: 10.1073/pnas.2022410118.
- Background: PubMed 33012527Hamburger AE, DiAndreth B, Cui J, Daris ME, Munguia ML, Deshmukh K, Mock JY, Asuelime GE, Lim ED, Kreke MR, Tokatlian T, Kamb A. Engineered T cells directed at tumors with defined allelic loss. Mol Immunol. 2020 Dec;128:298-310. doi: 10.1016/j.molimm.2020.09.012. Epub 2020 Oct 1.
- A2 Biotherapeutics Inc.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study data will be shared within 1 year of study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Welch, MD, PhD study director
A2 Biotherapeutics
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing A2B395 and xT CDx with HLA-LOH assay in people with Solid Tumor, Adult and Colorectal Cancer, run by A2 Biotherapeutics Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials (310-431-9180, ClinicalTrials@a2bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level (time frame: From the time of Informed consent until 24 months (2 years) post A2B395 infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06682793, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.