Immunophenotypic Evaluation of CD305 and CD85d in B-Cell Lymphoid Neoplasms

March 24, 2026 updated by: Amira Saber Hamed Ahmed, Assiut University

Immunophenotypic Evaluation of Inhibitory Immune Receptors CD305 and CD85d in B-Cell Lymphoid Neoplasms

Inhibitory immune receptors, including CD85d and CD305 (LAIR-1), act as immune checkpoint-like molecules. They contain immunoreceptor tyrosine-based inhibitory motifs (ITIMs) that recruit SH2-domain phosphatases (e.g., SHP-1), which suppress cellular activation (7,8).

CD85d is predominantly expressed in myeloid cells, including monocytes, macrophages, dendritic cells, and granulocytes. It is also differentially expressed on NK, T, B cells, and neutrophils. It is expressed at high levels in tumor cells, facilitating immune escape by promoting immune suppression, allowing for tumor evasion (9).

CD85d is widely expressed across AML, so it is a top candidate, due to its traditional association with myeloid phenotypes and limited expression in normal haematopoiesis (10). It was reported to be expressed in B cells of CLL patients in contrast to normal B cells. Its expression in CLL patients denotes a distinctive feature, which may be acquired during malignant transformation (8). Therefore, CD85d may have significant prognostic, mechanistic, and therapeutic roles in hematologic malignancies (11).

As a novel biomarker in solid malignant tumors to predict the prognosis of patients, upregulation of CD85d in tumors is associated with worse tumor phenotypes. Targeting CD85d may be an effective tool for targeted cancer therapy (12).

Concerning CD305, it has been reported in about 60% of CLL patients and may be used as an effective prognostic marker to predict TTFT in CLL patients (13).

Despite their potential clinical significance, the expression patterns of CD85d and CD305 across B-cell lymphoid neoplasms subtypes remain incompletely identified. Illustrating their role may help to determine TTFT, prognosis, therapeutic targeting, and refinement of B-cell neoplasms classification in line with WHO-HAEM5 standards.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

B-cell lymphoproliferative disorders (B LPDs) constitute a wide spectrum of clonal B-cell neoplasms, ranging from indolent chronic illness to more aggressive hematologic malignancies. Clinically, patients may present with lymphadenopathy, splenomegaly, cytopenias, or, in chronic cases, may be diagnosed accidentally by the presence of lymphocytosis during routine complete blood counts, confirmed by immunophenotyping showing a monoclonal B-cell population (1).

According to the World Health Organization Classification of Haematolymphoid Tumours, 5th edition (WHO HAEM5), mature B-cell neoplasms are diagnosed by integrating morphology, immunophenotyping, cytogenetics, and molecular features. Major B-CLPD subtypes include chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), hairy cell leukemia (HCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL), and lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM) (2). Accurate immunophenotypic diagnosis is essential as it helps to identify distinct prognoses and therapeutic approaches.

B-cell acute lymphoblastic leukemia/lymphoma is the most common pediatric leukemia, representing about 85% of ALL cases in children and 75% in adults. B-cell acute lymphoblastic leukemia/lymphoma is a precursor B-lineage neoplasm comprising lymphoblasts that express CD19, CD22, CD79a, and/or PAX5, besides the expression of immaturity markers such as TdT and CD34, while lacking surface immunoglobulin expression (3-5). Its inclusion differentiates the spectrum of B-cell neoplasms from precursor to mature stages.

Management of asymptomatic patients with B-CLPDs commonly follows a "watch and wait" strategy, whereas B-ALL requires prompt therapeutic intervention. Prognostic indicators in B-CLPDs, such as genetic mutations detected by fluorescence in situ hybridization (FISH) (del(17p), del(11q), trisomy 12, del(13q)), IGHV gene somatic hypermutation status, and TP53 mutations, can guide risk stratification and predict time to first treatment (TTFT) (6).

Inhibitory immune receptors, including CD85d and CD305 (LAIR-1), act as immune checkpoint-like molecules. They contain immunoreceptor tyrosine-based inhibitory motifs (ITIMs) that recruit SH2-domain phosphatases (e.g., SHP-1), which suppress cellular activation (7,8).

CD85d is predominantly expressed in myeloid cells, including monocytes, macrophages, dendritic cells, and granulocytes. It is also differentially expressed on NK, T, B cells, and neutrophils. It is expressed at high levels in tumor cells, facilitating immune escape by promoting immune suppression, allowing for tumor evasion (9).

CD85d is widely expressed across AML, so it is a top candidate, due to its traditional association with myeloid phenotypes and limited expression in normal haematopoiesis (10). It was reported to be expressed in B cells of CLL patients in contrast to normal B cells. Its expression in CLL patients denotes a distinctive feature, which may be acquired during malignant transformation (8). Therefore, CD85d may have significant prognostic, mechanistic, and therapeutic roles in hematologic malignancies (11).

As a novel biomarker in solid malignant tumors to predict the prognosis of patients, upregulation of CD85d in tumors is associated with worse tumor phenotypes. Targeting CD85d may be an effective tool for targeted cancer therapy (12).

Concerning CD305, it has been reported in about 60% of CLL patients and may be used as an effective prognostic marker to predict TTFT in CLL patients (13).

Despite their potential clinical significance, the expression patterns of CD85d and CD305 across B-cell lymphoid neoplasms subtypes remain incompletely identified. Illustrating their role may help to determine TTFT, prognosis, therapeutic targeting, and refinement of B-cell neoplasms classification in line with WHO-HAEM5 standards.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Assiut University Hospital patients

Description

Inclusion Criteria:

  • - Newly diagnosed cases of B-cell acute lymphoblastic leukemia/lymphoma or B CLPDs according to the WHO classification and established by morphology, immunophenotyping, and, if available, cytogenetic/molecular findings.

Exclusion Criteria:

  • Patients diagnosed with hematologic malignancies other than B-cell acute lymphoblastic leukemia/lymphoma or B CLPDs.
  • Patients who have received prior therapy, including chemotherapy or immunomodulatory treatment.
  • Patients refused to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
60 patients diagnosed with B-cell lymphoproliferative disorders (B LPDs).
B-cell lymphoproliferative disorders (B LPDs), including chronic B-cell neoplasms diagnosed by flow cytometry
60 patients diagnosed with B-cell acute lymphoblastic leukemia/lymphoma.
B-cell acute lymphoblastic leukemia/lymphoma diagnosed by flow cytometry
(control group): 60 apparently healthy individuals
will be included as a control group for comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect the expression of both CD85d and CD305 in B-cell acute lymphoblastic leukemia/lymphoma and B CLPDs.
Time Frame: Baseline
detect the expression level in comparison to normal
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlate the expression of CD85d and CD305 with different B-cell lymphoproliferative disorders subtypes and B-cell acute lymphoblastic leukemia/lymphoma.
Time Frame: Baseline
Correlate the expression level with different subtypes
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Hesham Abdel-Raheem Abdel-Baset, Professor, Assiut University
  • Principal Investigator: Al Shaimaa Mokhtar Selim, Assiut University
  • Principal Investigator: Zeinab Albadry Zahran, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 6, 2026

Primary Completion (Estimated)

September 6, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CD305 and CD85d

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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