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Investigate the safety and efficacy of lymphoma immunotherapy

The safety and efficacy of tumour pulsed dendritic cells and cytokine induced killer cells for lymphoma and later stage pancreatic carcinoma treatment ex vivo

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000988954
Enrollment
30
Registered
2011-09-16
Start date
2010-05-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Dendritic cell (DC) and cytokine induced killer cell (CIK)-based therapy can induce specific antitumor T cell responses. This clinical pilot study examines feasibility and outcome of the tumour specific treatment for patients with advanced lymphoma and later stage pancreartic carcinoma. Procedures: Alpha-gal epitopes are synthesized on pancreatic carcinoma and lymphoma cell membrane with enzyme(alpha galactosyltransferase) in vitro. Subsequently, the processed membranes in the presence of human natural anti-Gal epitope IgG, resulted in the opsonisation of the effective phagocytosis by dendritic cells (DCs) which are co-cultured with cytokine induced killer cells (CIKs) to generate pancreatic carcinoma and lymphoma specific immune responders ex vivo.

Interventions

Alpha galactosyl epitopes are synthesized on lymphoma and pancreatic carcinoma cell membrane with alpha1,3-galactosyltransferase in vitro. Subsequently, the processed cancer cell membranes in the presence of human natural anti-Gal IgG, result in the opsonisation of the effective phagocytosis by dendritic cells which are co-cultured with the newly differentiated T/CIKs (cytokine induced killer cells) from bone marrow stem cells to generate tumour specific immune responders ex vivo. The lymphoma a

Alpha galactosyl epitopes are synthesized on lymphoma and pancreatic carcinoma cell membrane with alpha1,3-galactosyltransferase in vitro. Subsequently, the processed cancer cell membranes in the presence of human natural anti-Gal IgG, result in the opsonisation of the effective phagocytosis by dendritic cells which are co-cultured with the newly differentiated T/CIKs (cytokine induced killer cells) from bone marrow stem cells to generate tumour specific immune responders ex vivo. The lymphoma and pancreatic cancer patients receive the first injection on the third day of finishing the radio- or chemotherapy, and the subsequent doses are given every week. The first single dose is initiated at 2X10(9) cells iv injection. If no side-effects, iv injection dosage increases to 10X10(9) on the second week, and escalates to 20x10(9) cells on the third week. The total injections are 3-6 times depending on the avaibility of tumour sample. The safety and effectiveness are investigated. For example, the phenotype (CD3, CD4, CD8, CD16, CD19, CD45RO and CD56) and interferon-gamma expression in the peripheral blood lymphocytes are measured before injection and one week after the third injection.

Sponsors

The First Teaching Hospital, Inner Mongolia Medical College
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
12 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Karnofsky score> 70; low possible maintenance dose of glucocorticoid therapy (Prednisone 10mg/day, less than one month); no allergy to components of the DCs and CIKs.

Exclusion criteria

cachexia; HIV positive; drug addictive, pregnant; severe pulmonary and cardiac diseases; history of an autoimmune disorder and prior history of other malignancies

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026