Health TrialsbyHealthPanel

Combination Immunotherapy Targeting Melanoma

ConditionMelanoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Geno-Immune Medical Institute

About this trial

The purpose of this study is to assess the feasibility, safety and efficacy of combination immunotherapy based on CAR T cells, cytotoxic T lymphocytes (CTLs), and dendritic cell (DC) vaccines modified with GM-CSF and B7-2 (CD86) against melanoma, which targets CAR T specific surface antigens such as GD2, CTL specific antigens such as MAGE-A4, gp100 and a pool of melanoma specific antigens presented by the DCs. Another goal of the study is to learn more about the function and persistence of the CAR T cells and antigen-specific immune effectors in patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with melanoma have received standard first-line therapy and have been diagnosed with non-resectable, metastatic, progressive or recurrent conditions.

The expression of melanoma specific antigens is immunohistochemically stained and verified.

Body weight greater than or equal to 40 kg.

Age: ≥18 year and ≤ 75 years of age at the time of enrollment.

Disqualifiers

Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, with the exception of grade 3 hematologic toxicity.

Untreated central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 4 weeks following completion of therapy are eligible.

Previous treatment with other genetically engineered CAR T cells.

Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • Antigen-specific CAR T, CTL and DCvac to treat melanoma.

    Biological/Vaccine

    Antigen-specific CAR T, CTL and DCvac to treat melanoma.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: CAR T/CTL/DCvac cells to treat melanomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with adverse events

The toxicity profile of CAR T, CTL or DCvac is determined by Common Toxicity Criteria for Adverse Effects version 4.0

Time frame
1 year

Secondary outcomes

1

Anti-tumor effects

Disease status is defined by the measurement of biochemical markers and image scan, and the outcome of treatment is classified as Complete Response/remission (CR), Very Good Partial Response/remission (VGPR), etc.

Time frame
1 year
2

The expansion and persistency of antigen-specific CAR T cells

The investigators will monitor the expansion and functional persistency of CAR T cells in the peripheral blood of patients and examine their correlation with antitumor effects.

Time frame
1 year
3

Immune responses after CAR T and CTL infusions and DCvac injections

IL-2 cytokine secretion profile will be assessed

Time frame
1 year
4

Immune responses after CAR T and CTL infusions and DCvac injections

IFN-γ cytokine secretion profile will be assessed

Time frame
1 year

Other outcomes

Sponsors and contacts

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

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: