Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies (NCT05290155) | Clinical Trial Compass
CompletedPhase 1
Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies
China14 participantsStarted 2022-05-04
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of CAR T cell treatment targeting CD7 in patients with relapsed or refractory CD7 positive T-cell hematological maliganacies
Who can participate
Age range14 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.
✓. Confirmed diagnosis of acute T cell leukemia and screened for CD7 positive,including following conditions:a. Patients who do not get a CR with ≥2 prior induction therapy b. Those who achieves CR, but have a early relapse(\<12months),or a late relapse (\>=12months) failing to acheive a CR after re-induction chemotherapy c. For any Patiens failed ASCT/allo-SCT
✓. Relapsed and refractory patients with diagnosis of CD7 positive T cell lymphoma have had≥2 prior lines of therapy,who do not acheive at least a PR, or have a relapse including:a. Peripheral T cell lymphoma NOS, or b.Angioimmunoblastic T cell lymphoma,or c. Anaplastic large cell lymphoma c.Disease can be assessed(BM or CT scan)
✓. Confirmed T lymphoblastic lymphoma：a. Patients who do not get a PR with ≥2 induction chemotherapy or a CR with ≥ 4 induction chemotherapy b. Relapsed patients failing to achieve a CR after 1 line salvage chemotherapy c. For any Patients failed ASCT/allo-SCT .Disease can be assessed(BM or CT scan)
✓. The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
✓. Liver, kidney and cardiopulmonary functions meet the following requirements: a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction \>50%; c.Baseline oxygen saturation\>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST≤ 3×ULN;
✓. Able to understand and sign the Informed Consent
Exclusion criteria
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events
Timeframe: 28 days post infusion
Trial details
NCT IDNCT05290155
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine
. Malignant tumors other than T cell malignancies 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 including bacteral or virus or fugal disease;patients with positive HBsAg or HBcAb and positive peripheral blood HBV DNA titer detection ;HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody 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;
✕. Any uncontrolled disease may affect entry
✕. 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;
✕. Subjects treated with anti-PD1 or anti-PDL1 therapies within 3months before enrollment
✕. 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;