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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04828174
Other study ID # SHYSXY-202101-CART
Secondary ID
Status Suspended
Phase Phase 1
First received
Last updated
Start date March 31, 2021
Est. completion date November 26, 2023

Study information

Verified date November 2023
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Suspended
Enrollment 9
Est. completion date November 26, 2023
Est. primary completion date November 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: (1)18 to 70 Years Old, Male and female; (2) Expected survival > 12 weeks; (3) ECOG score 0-2; (4) Confirmed diagnosis of acute T cell leukemia and screened for TRBC1 positive, including following conditions: 1. Patients who do not get a CR with =2 prior lines of therapy 2. 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 3. 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: a. Peripheral T cell lymphoma NOS, or b. Angioimmunoblastic T cell lymphoma, or c. Anaplastic large cell lymphoma (6) Confirmed T lymphoblatic lymphoma 1. Patients who do not get a CR with =2 prior lines of therapy 2. Relapsed patients failing to acheive a CR after 1 line salvage chemotherapy 3. 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: 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; (9) Able to understand and sign the In Exclusion Criteria: 1. 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; 2. 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; 3. 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; 4. Any uncontrolled disease may affect entry 5. 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) 6. 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; 7. 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; 8. Active or uncontrollable infection requiring systemic therapy 9. Received CAR-T treatment or other gene therapies before enrollment; 10. Kown be allergic to anti-TRBC1 CAR-T cells or drugs(Fludarabine or Cyclophophamide) 11. The investigators consider other conditions unsuitable for enrollment. 12. Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
anti-TRBC1 CAR-T cell therapy
TRBC1 positve patients with relapsed or refractory T cell malignacy will receive CAR-T cell therapy targetting TRBC1

Locations

Country Name City State
China Xianmin Song Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and Tolerability Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0 28 days post infusion
Secondary CAR-T cell expansion and persistence To evaluate anti-TRBC1 CAR-T cell expansion and persistence after infusion 2 years post infusion
Secondary Total response rate (ORR) after administration CR+CRi for T-ALL CR+PR for T cell lyphoma 3 months post infusion
Secondary Duration of remission (DOR) after administration Duration of remission (DOR) after administration 2 years post infusion
Secondary Overall Survival (OS)after administration Overall Survival (OS)after administration 2 years post infusion
Secondary Progression Free Survival (PFS) after infusion Progression Free Survival (PFS) after infusion 2 years after infusion
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