Solid Tumor, AdultBASECAMP-1NCT04981119
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
An observational study of Solid Tumor, Adult and Colorectal Cancer, run by A2 Biotherapeutics Inc. at 16 sites in United States.
Trial summary
Objective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. 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 Cancer
- What is being tested?
- Apheresis, Next Generation Sequencing (NGS) and Long Range NGS HLA typing
- How many people
- 500 participants
- Where
- 16 sitesUnited States
- Study dates
- 29 Oct 2021to Apr 2029
- Phase
- Observational
- 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
Study population: Participants with Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years, germline HLA-A*02 heterozygous, and have confirmed somatic LOH.
Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria
- Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.
Part 1: Key Exclusion Criteria
- History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
- Prior allogeneic stem cell transplant.
- Prior solid organ transplant.
Part 2 : Key Inclusion Criteria
- Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.
- Participants are germline HLA-A*02 heterozygous confirmed by HLA typing.
- Primary tumor tissue showing LOH of HLA-A*02 by NGS testing.
- Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.
Part 2: Key Exclusion Criteria
- History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
- Prior allogeneic stem cell transplant.
- Prior solid organ transplant.
- Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).
- Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.
- In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 13 recruiting
- Completed
Massachusetts General Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, 02114
- Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Dudbeth Brown, 614-685-7034, Dudbeth.Brown@osumc.edu
Jinesh Gheeya, MD, PhD
- Completed
City of Hope
Duarte, California, 90101
- Recruiting
Banner Health
Gilbert, Arizona, 85234
Jace Luzania, 480-256-5483, Jace.Luzania@bannerhealth.com
Matthew Ulrickson, MD
- Completed
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Rhoda Romain, Romain.Rhoda@mayo.edu
Yanyan Lou, MD, PhD
- Recruiting
University of California San Diego
La Jolla, California, 92093
Anthony Oshmago, aoshmago@health.ucsd.edu
Sandip Patel, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO), 1-800-811-8480, CTIP@VUMC.ORG
Cathy Eng, M.D., FACP, FASCO
- Recruiting
NYU Langone Medical Center
New York, New York, 10016
Phase 1 Screening, DL_NTPH1@nyulangone.org
Kristen Spencer, DO
- Recruiting
Stanford University
Palo Alto, California, 94304
Vivian Leung, vivian0@stanford.edu
Wen-Kai Weng, MD
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
Clinical Trials Referral Office, 855-776-0015
Antonious Hazim, MD
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Ethan Sundsvold, Sundsvold.Ethan@mayo.edu
Julian Molina, MD, PhD
- Recruiting
UCLA Medical Center
Santa Monica, California, 90404
Karla Largaespada, KLargaespada@mednet.ucla.edu
J. Randolph Hecht, MD
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Shelby Colden
scolden2@fredhutch.org
- Recruiting
Washington University
St Louis, Missouri, 63110
Hussain Hassan, hahassan@wustl.edu
Patrick Grierson, MD, PhD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33136
Katie Ehm, Katie.Ehm@moffitt.org
Kedar Kirtane, MD
About this study
Official title: An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing
Objective:
To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.
Read more
Design:
This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
Read the detailed description
Background:
Human Leukocyte Antigen (HLA) is a protein on the outside of cells that allows the immune system to recognize it's own cells as normal and leave them alone or respond if infected with a virus or bacteria, or a tumor cell. HLA might not be expressed normally on cancer cells. This may be why cancer can grow undetected by the immune system and is referred to as a tumor escape mechanism. Tumor escape can occur for many reasons, but one reason is Loss of Heterozygosity (LOH). LOH is the loss of one of the genes that encodes HLA protein. A2 Biotherapeutics, Inc. (A2 Bio) is developing therapies to recognize, target, and kill cancer cells that do not express HLA normally, and minimize any damage to normal cells that express normal HLA.
Once participants are identified as having LOH on their tumors, apheresis, a procedure to separate and collect white blood cells will be performed. It is the first required step in manufacturing CAR T-cell therapy. The collected T cells will be stored for patients that are likely to benefit from CAR T-cell therapy during their disease care.
Study Design:
Approximately 3000 participants will be screened for part 1 of the study, including HLA typing, approximately 1500 participants will have NGS testing on their tumor samples and be followed for up to 2 years on the study, and up to 500 participants will be screened for part 2 of the study and enrolled if eligible and apheresed and be followed for up to 2 years on the study.
Participants will be screened (Part 1) for HLA type, and based on results, participants will have archived tumor tissue tested by next generation sequencing (NGS) and be followed for up to 2 years. Based on the tumor NGS results, participants may be apheresed (Part 2) for Peripheral Blood Mononuclear Cell (PBMC) collection to store their T cells for a future interventional study upon relapse.
Each participant will proceed through the following study periods:
- Screening (Part 1 and 2)
- Enrollment (Apheresis)
- Post Apheresis safety follow-up (Day 7)
- Two-year long term follow-up
- Conditions
- Solid Tumor, Adult, Colorectal Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer, CRC, NSCLC
- Being tested
- Apheresis, Next Generation Sequencing (NGS), Long Range NGS HLA typing
- Keywords
- CAR T Cell Therapy, Next Generation Sequencing, Leukapheresis, Apheresis, Immunotherapy
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Mesothelioma, Ovarian Neoplasms, Mesothelioma, Malignant, Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApheresisOther
Apheresis procedure performed for collection of PBMCs.
Next Generation Sequencing (NGS)Diagnostic test
NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers.
Long Range NGS HLA typingDiagnostic test
Long range NGS on whole blood to determine germline HLA type.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis
Participants will be followed for their status of enrollment on an A2 Biotherapeutics, Inc. interventional study
Measured: up to 2 years
Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing
Percentage of participants experiencing LOH will be calculated based on NGS results
Measured: Screening
Secondary outcomes (1)
Percentage of enrolled participants who experience an adverse event (AE) related to apheresis
Adverse events will be collected and monitored for relatedness to apheresis during the course of the study
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start29 Oct 2021
- Primary completionDec 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A2 Biotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tempus AI
- Responsible party
- Sponsor
- Investigators
- Eric W Ng, MD, FAAP, Study director, A2 Biotherapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981119
- Sponsor's protocol ID
- A2B101-101
- Acronym
- BASECAMP-1
- Status last verified
- Sep 2026
- First submitted
- 19 Jul 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.
PubMed 33532112Hamburger 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 33012527Hwang 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 33731480Perera J, Mapes B, Lau D, et al. Detection of human leukocyte antigen class I loss of heterozygosity in solid tumor types by next-generation DNA sequencing. J Immunother Cancer. 2019, 7(Suppl 1):P103
Beroukhim 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 20164920McGranahan N, Rosenthal R, Hiley CT, Rowan AJ, Watkins TBK, Wilson GA, Birkbak NJ, Veeriah S, Van Loo P, Herrero J, Swanton C; TRACERx Consortium. Allele-Specific HLA Loss and Immune Escape in Lung Cancer Evolution. Cell. 2017 Nov 30;171(6):1259-1271.e11. doi: 10.1016/j.cell.2017.10.001. Epub 2017 Oct 26.
PubMed 29107330Priestley P, Baber J, Lolkema MP, Steeghs N, de Bruijn E, Shale C, Duyvesteyn K, Haidari S, van Hoeck A, Onstenk W, Roepman P, Voda M, Bloemendal HJ, Tjan-Heijnen VCG, van Herpen CML, Labots M, Witteveen PO, Smit EF, Sleijfer S, Voest EE, Cuppen E. Pan-cancer whole-genome analyses of metastatic solid tumours. Nature. 2019 Nov;575(7781):210-216. doi: 10.1038/s41586-019-1689-y. Epub 2019 Oct 23.
PubMed 31645765Hecht JR, Molina JR, Liechty K, Welling TH, Grierson PM, Patel SP, Kirtane K, Morelli MP, Locke FL, Maloney DG, Punekar SR, Nikiforow S, Lin Y, Ulrickson M, Specht JM, Lozac'hmeur A, Osterman CK, Garde RJ, Rangel GA, Ng EW, Welch JS, Tebbets JC, Go WY, Simeone DM. BASECAMP-1 screening study: a model for efficient enrolment in precision oncology clinical trials. BMJ Oncol. 2026 Mar 27;5(1):e001033. doi: 10.1136/bmjonc-2025-001033. eCollection 2026.
PubMed 41918932
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing
- ClinicalTrials.gov ID
- NCT04981119
- Acronym / sponsor ID
- BASECAMP-1 / A2B101-101
- Conditions
- Solid Tumor, Adult, Colorectal Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer, CRC, NSCLC
- Keywords
- CAR T Cell Therapy, Next Generation Sequencing, Leukapheresis, Apheresis, Immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- A2 Biotherapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tempus AI
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 28 Jul 2021 (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.
Objective:
To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.
Design:
This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
Detailed description
Background:
Human Leukocyte Antigen (HLA) is a protein on the outside of cells that allows the immune system to recognize it's own cells as normal and leave them alone or respond if infected with a virus or bacteria, or a tumor cell. HLA might not be expressed normally on cancer cells. This may be why cancer can grow undetected by the immune system and is referred to as a tumor escape mechanism. Tumor escape can occur for many reasons, but one reason is Loss of Heterozygosity (LOH). LOH is the loss of one of the genes that encodes HLA protein. A2 Biotherapeutics, Inc. (A2 Bio) is developing therapies to recognize, target, and kill cancer cells that do not express HLA normally, and minimize any damage to normal cells that express normal HLA.
Once participants are identified as having LOH on their tumors, apheresis, a procedure to separate and collect white blood cells will be performed. It is the first required step in manufacturing CAR T-cell therapy. The collected T cells will be stored for patients that are likely to benefit from CAR T-cell therapy during their disease care.
Study Design:
Approximately 3000 participants will be screened for part 1 of the study, including HLA typing, approximately 1500 participants will have NGS testing on their tumor samples and be followed for up to 2 years on the study, and up to 500 participants will be screened for part 2 of the study and enrolled if eligible and apheresed and be followed for up to 2 years on the study.
Participants will be screened (Part 1) for HLA type, and based on results, participants will have archived tumor tissue tested by next generation sequencing (NGS) and be followed for up to 2 years. Based on the tumor NGS results, participants may be apheresed (Part 2) for Peripheral Blood Mononuclear Cell (PBMC) collection to store their T cells for a future interventional study upon relapse.
Each participant will proceed through the following study periods:
- Screening (Part 1 and 2)
- Enrollment (Apheresis)
- Post Apheresis safety follow-up (Day 7)
- Two-year long term follow-up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years, germline HLA-A*02 heterozygous, and have confirmed somatic LOH.
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 |
|---|---|---|
| ApheresisApheresis procedure performed for collection of PBMCs. | Other | – |
| Next Generation Sequencing (NGS)NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers. | Diagnostic test | – |
| Long Range NGS HLA typingLong range NGS on whole blood to determine germline HLA type. | Diagnostic test | – |
Primary outcome
Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis
Time frame: up to 2 years
Participants will be followed for their status of enrollment on an A2 Biotherapeutics, Inc. interventional study
Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing
Time frame: Screening
Percentage of participants experiencing LOH will be calculated based on NGS results
1 secondary outcome
Percentage of enrolled participants who experience an adverse event (AE) related to apheresis
Time frame: 7 days
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 26 Oct 2026.
- Background: PubMed 33532112Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.
- 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.
- 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.
- BackgroundPerera J, Mapes B, Lau D, et al. Detection of human leukocyte antigen class I loss of heterozygosity in solid tumor types by next-generation DNA sequencing. J Immunother Cancer. 2019, 7(Suppl 1):P103
- 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 29107330McGranahan N, Rosenthal R, Hiley CT, Rowan AJ, Watkins TBK, Wilson GA, Birkbak NJ, Veeriah S, Van Loo P, Herrero J, Swanton C; TRACERx Consortium. Allele-Specific HLA Loss and Immune Escape in Lung Cancer Evolution. Cell. 2017 Nov 30;171(6):1259-1271.e11. doi: 10.1016/j.cell.2017.10.001. Epub 2017 Oct 26.
- Background: PubMed 31645765Priestley P, Baber J, Lolkema MP, Steeghs N, de Bruijn E, Shale C, Duyvesteyn K, Haidari S, van Hoeck A, Onstenk W, Roepman P, Voda M, Bloemendal HJ, Tjan-Heijnen VCG, van Herpen CML, Labots M, Witteveen PO, Smit EF, Sleijfer S, Voest EE, Cuppen E. Pan-cancer whole-genome analyses of metastatic solid tumours. Nature. 2019 Nov;575(7781):210-216. doi: 10.1038/s41586-019-1689-y. Epub 2019 Oct 23.
- Derived from this study: PubMed 41918932Hecht JR, Molina JR, Liechty K, Welling TH, Grierson PM, Patel SP, Kirtane K, Morelli MP, Locke FL, Maloney DG, Punekar SR, Nikiforow S, Lin Y, Ulrickson M, Specht JM, Lozac'hmeur A, Osterman CK, Garde RJ, Rangel GA, Ng EW, Welch JS, Tebbets JC, Go WY, Simeone DM. BASECAMP-1 screening study: a model for efficient enrolment in precision oncology clinical trials. BMJ Oncol. 2026 Mar 27;5(1):e001033. doi: 10.1136/bmjonc-2025-001033. eCollection 2026.
- A2 Bio websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Eric W Ng, MD, FAAP study director
A2 Biotherapeutics Inc.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Adult and Colorectal Cancer, run by A2 Biotherapeutics Inc. at 16 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?
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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
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?
Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis (time frame: up to 2 years). The study lists 2 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 NCT04981119, which also lists 8 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 26 Oct 2026.