Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
BASECAMP-1
An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing
1 other identifier
observational
200
1 country
16
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedStudy Start
First participant enrolled
October 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
April 30, 2026
April 1, 2026
7.1 years
July 19, 2021
April 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Screening
Secondary Outcomes (1)
Percentage of enrolled participants who experience an adverse event (AE) related to apheresis
7 days
Interventions
Long range NGS on whole blood to determine germline HLA type.
Apheresis procedure performed for collection of PBMCs.
NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers.
Eligibility Criteria
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.
You may qualify if:
- \. 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.
You may not qualify if:
- 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.
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tempus AIcollaborator
- A2 Biotherapeutics Inc.lead
Study Sites (16)
Banner Health
Gilbert, Arizona, 85234, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
City of Hope
Duarte, California, 90101, United States
University of California San Diego
La Jolla, California, 92093, United States
Stanford University
Palo Alto, California, 94304, United States
UCLA Medical Center
Santa Monica, California, 90404, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Moffitt Cancer Center
Tampa, Florida, 33136, United States
Massachusetts General Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, 02114, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
NYU Langone Medical Center
New York, New York, 10016, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Related Publications (8)
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.
PMID: 33532112BACKGROUNDHamburger 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.
PMID: 33012527BACKGROUNDHwang 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.
PMID: 33731480BACKGROUNDPerera 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
BACKGROUNDBeroukhim 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.
PMID: 20164920BACKGROUNDMcGranahan 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.
PMID: 29107330BACKGROUNDPriestley 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.
PMID: 31645765BACKGROUNDHecht 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.
PMID: 41918932DERIVED
Related Links
Biospecimen
Blood or saliva, or buccal swabs will be obtained to determine germline HLA type as wells a germline comparison for tumor comparison. Archived tumor tissue samples will be obtained for NGS to determine LOH status of tumor tissue. DNA and RNA will be retained for enrolled participants only, if repeat testing if required. No further genetic testing will be performed on these samples. Peripheral Blood Mononuclear Cells (PBMCs) will be collected for enrolled subjects, enriched for T cells and cryopreserved for future manufacturing of an A2 Biotherapeutics, Inc. CAR T-cell therapy upon participant relapse. No further genetic testing will be performed on this sample. Archival tumor slides will be obtained for immunohistochemistry (IHC)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric W Ng, MD, FAAP
A2 Biotherapeutics Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2021
First Posted
July 28, 2021
Study Start
October 29, 2021
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
April 1, 2029
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share