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Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing

ConditionsSolid Tumor, AdultColorectal CancerNon Small Cell Lung CancerPancreatic CancerCRCNSCLCPancreas CancerMesotheliomaOvarian CancerOvarian NeoplasmsOvarian CarcinomaMesothelioma, MalignantMesothelioma; LungCancerTriple Negative Breast Cancer (TNBC)Renal Cell Carcinoma (Kidney Cancer)Head and Neck Squamous Cell Carcinoma HNSCC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorA2 Biotherapeutics Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Apheresis

    Other intervention

    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 typing

    Diagnostic test

    Long range NGS on whole blood to determine germline HLA type.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
up to 2 years
2

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

Time frame
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

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

A2 Biotherapeutics Inc.

Lead sponsor

Tempus AI

Collaborator

Source ClinicalTrials.gov
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