Clinical trial of autologous tumor-specific T cells

A Phase I study of autologous hTERT-specific CD8+ T cell immunotherapy in patients with advanced solid tumors who failed standard therapy

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0004064

Enrollment

Registered

2019-06-13

Start date

2014-04-29

Completion date

Unknown

Last updated

2019-06-17

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

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : 1. Drug: autologous hTERT-specific cD8 T cells (TERTiNT cells) 2. Dose - Dose 1: 4.0 x 10e8/m2 (day 0) - Dose 2: 1g/m2 cytoxan (day -3) + 4.0 x 10e8/m2 (d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects must be 20 ~ 75 years old 2) Patients with standard therapy-failed reccurrent sold cancers 3) Patients with hTERT-specific CD8 T cells in prior epitope screening. 4) Performance Status Score (ECOG/Zubrod Scale) must be =< 2

Exclusion criteria

Exclusion criteria: 1) Patients who have Symptoms- or unregulated with metastasis in CNS 2) Patients recieved all immunosuppressive treatments such as chemotherapy or radiotherapy a minimum of 3 weeks prior to initiation of study 3) Leukocyte number < 2,500/ul, absolute numbers of neutrophils < 1,000/ul, platelet numbers < 50,000/ul, hemoglobin <9g/dL, serum creatinine > 2.0mg/dL, AST/ALT > 3x upper limit of normal range (ULN), total bilirubin > 2.0 mg/dL, Prothrombin time > 1.5 x ULN 4) Active cardiovascular diseases, including: unregulated hypertension( Systolic blood pressure>180mmHg, Diastolic blood pressure>100mmHg), Unstable angina, Pulmonary embolisim, cerebrovascular disease, valvular disease of the heart , congestive heart failure or myocardial infarction in the last 6 months, or severe arrhythmia 5) Anti-HIV Ab positive 6) Patients with active autoimmune diseases or inflammatory diseases 7) Uncontrolled active infection/neurologic diseases 8) Patients with a previous history of immune cell therapy 9) Pregnant or breast-feeding women

Design outcomes

Primary

Measure	Time frame
To determine maximum tolerated dose of autologous hTERT-specific CD8 T cells in patients with standard therapy-failed recurrent solid cancers	—

Secondary

Measure	Time frame
Dose-limiting toxicity;safety;adverse effects;effectiveness	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Joo Lee

NCC Hospital

yjlee@ncc.re.kr+82-31-920-1694

Outcome results