Multicentre Phase I Trial of Engineered T Cells for Patients With Relapsed or Refractory Primary Cutaneous CD30+ Large T Cell Lymphoma or Transformed CD30+ Mycosis Fungoides (TECLA)

University of Cologne

Status and phase

Unknown

Phase 1

Conditions

CD30 Positive Cutaneous T Cell Lymphoma

CD30 Positive Transformed Mycosis Fungoides

Treatments

Genetic: Genetically modified T cells # 1138

Study type

Interventional

Funder types

Other

Identifiers

NCT01645293

Uni-Koeln-1065

Details and patient eligibility

About

Patients with cutaneous CD30 positive lymphoma will receive systemical and topical treatment with their own genetically modified T cells. Treatment evaluation consists of assessment of safety and preliminary evidence of response.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed written informed consent, prior to pre-study screening and treatment, with the understanding that the consent may be withdrawn by the patient at any time without prejudice, ability to understand the written informed consent document.
Male or female > 18 years of age to 70 years of age
Diagnosis of primary cutaneous CD30+ large T cell lymphoma OR
Diagnosis of transformed CD30+ mycosis fungoides, i.e.,
Histological confirmation of diagnosis.
multiple (> 5) cutaneous tumor lesions (TNM EORTC 2007 T3, N1, clinical stage <IIb),
Measurable disease according to RECIST criteria
Refractory or relapsed disease after at least one line of treatment, e.g. PUVA (Psoralen plus UVA), PUVA + Interferon, oral Bexarotene, low dose MTX)
ECOG performance status 0-3
Life expectancy > 12 months
Female patients with childbearing potential must have a negative serum pregnancy test within two weeks of first dose of study drug. Male and female patients must agree to use an effective oral contraceptive method while on study treatment, if appropriate, and for a minimum of twelve months following study therapy

Exclusion criteria

Previously untreated patients
Presence of any organ or brain involvement as determined during tumor staging by contrast computed tomography [CT] or magnetic resonance imaging [MRI] scan
Known hereditary blood coagulation disorders/DIC
Prior allogeneic hematopoietic stem-cell or organ transplantation
Severe cardiovascular disease like functionally restricting heart rhythm disturbance or heart malformation or severe hypertension, or cardiac insufficiency > NHYA-II
known active infection including HIV, Hepatitis B or C, VZV, or CMV
Insufficient bone marrow reserve (Leucocytes <3.500/μl; Thrombocytes <100.000/μl)
Creatinine-Clearance < 50 ml/min or Crea > 1.8 mg/dl
Bilirubin > 2 mg/dl; ASAT, ALAT > 2.5xN
Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
Known pulmonary dysfunction
Requirement of chronic immune suppression
Treatment with corticosteroids for concomitant or intercurrent disease
Having participated in another clinical trial or any IND in the preceding 4 weeks
Anti-cancer chemotherapy in the preceding 4 weeks
Known drug abuse/alcohol abuse
Known allergic/hypersensitivity reaction to any of the components of the treatment
Known serious uncontrolled infections
Known active secondary malignancy or other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the skin or cervix
Medical or psychological condition or inadequate knowledge of german language which in the opinion of the investigator would not permit the patient to complete the study or meaningfully sign informed consent
Legal incapacity or limited legal capacity