Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive… (NCT03590574) | Clinical Trial Compass
TerminatedPhase 1/2
Phase I/II Study Evaluating AUTO4 in Patients With T Cell Receptor Beta Constant (TRBC)1 Positive T Cell Lymphoma
Stopped: Only Phase I of the study was conducted.
Spain, United Kingdom20 participantsStarted 2018-08-30
Plain-language summary
The purpose of this study is to test the safety and efficacy of AUTO4 a chimeric antigen receptor (CAR) T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive selected T-Non-Hodgkin Lymphoma (NHL).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥ 18 years.
✓. Willing and able to give written, informed consent to be screened for TRBC1 positive T-NHL and to enter the main study.
✓. Confirmed diagnosis of selected T-NHL, including:
✓. Peripheral T cell lymphoma not otherwise specified, or
✓. Angioimmunoblastic T cell lymphoma, or
✓. Anaplastic large cell lymphoma
✓. Confirmed TRBC1 positive tumour.
✓. Relapsed or refractory disease and have had ≥1 prior lines of therapy.
Exclusion criteria
✕. Patients with T cell leukaemia.
✕. Females who are pregnant or lactating.
✕. Prior treatment with investigational gene therapy or approved gene therapy or genetically engineered cell therapy product or allogeneic stem cell transplant.
✕. Known history or presence of clinically relevant central nervous system (CNS) pathology. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS.
✕. Current or history of CNS involvement by malignancy.
What they're measuring
1
The Numbers of Patients With Grade 3 to 5 Toxicity Occurring Within 60 Days of AUTO4 Infusion.
Timeframe: 60 days of AUTO4 infusion
2
Frequency of Dose-limiting Toxicity (DLT) of AUTO4 Within 28 Days of AUTO4 Infusion.
✕. Patients with evidence of uncontrolled hypertension or with a history of hypertension crisis or hypertensive encephalopathy.
✕. Patients with a history (within 3 months) or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning.