Anti-TRBC1 CAR-T Cell Therapy in Patients With TRBC1 Positive T Cell Malignancies (NCT04828174) | Clinical Trial Compass
SuspendedPhase 1
Anti-TRBC1 CAR-T Cell Therapy in Patients With TRBC1 Positive T Cell Malignancies
Stopped: The trial was suspended due to the inability to enroll qualified participants
China9 participantsStarted 2021-03-31
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting TRBC1 in patients with relapsed or refractory TRBC1 positive T-cell hematological maliganacies
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients who do not get a CR with ≥2 prior lines of therapy
✓. Those who achieves CR, but have a early relapse(\<12months),or a late relapse (\>=12months) failing to acheive a CR after 1 line salvage chemotherapy
✓. For any Patiens failed ASCT/allo-SCT (5) Relapsed and refractory patients with diagnosis of T cell lymphoma have had≥2 prior lines of therapy,including:
✓. Patients who do not get a CR with ≥2 prior lines of therapy
✓. Relapsed patients failing to acheive a CR after 1 line salvage chemotherapy
✓. For any Patiens failed ASCT/allo-SCT (7) The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators; (8) Liver, kidney and cardiopulmonary functions meet the following requirements:
Exclusion criteria
✕. Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
✕. Uncontrolled infection;patients with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 10\^2 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
✕. Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
What they're measuring
1
Safety and Tolerability
Timeframe: 28 days post infusion
Trial details
NCT IDNCT04828174
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
✕. Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology. Patients with a known history or prior diagnosis other immunologic or inflammatory disease affecting the CNS (such as epilepsy)
✕. Patients who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
✕. Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pr egnancy within 1 year after cell transfusion;
✕. Active or uncontrollable infection requiring systemic therapy