Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101 (TREAT-ME 1)

Apceth

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Advanced Gastrointestinal Cancer

Treatments

Drug: MSC_apceth_101

Study type

Interventional

Funder types

Industry

Identifiers

MSC_apceth_101/1

Details and patient eligibility

About

To evaluate the safety and tolerability of MSC_apceth_101.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
Premature or scheduled termination of standard therapy
Progressive disease as clinically assessed by the investigator
Max. tumour lesion ≤ 5 cm
Adequate organ function
Ability of patient to understand character and individual consequences of clinical trial
Age ≥ 18 years
Written informed consent must be available before any study specific procedure is performed

Exclusion criteria

Patients with severe heart diseases
Clinical significant ischemic disease during the last 4 weeks before Visit 1
Severe lung disease
Symptomatic peritoneal carcinomatosis
Symptomatic pleural or pericardial effusion
Serious uncontrolled acute infections less than 3 weeks before Visit 1
Known dependency on alcohol or other drugs
Patients requiring corticoids in doses above the Cushing threshold
Known liver fibrosis or liver cirrhosis
Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator
Female patient who is pregnant or breast feeding
Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose