This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGIncidence and level of AE and SAE
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after CD7 CAR T-cells infusion
CAR-T cell expression
CAR-T cell expression in vivo
Time frame: Evaluate at 1, 2, 3, 4, 8,12,16, 20 and 24 weeks after CAR-T infusion
CAR-T related cytokine expression
CAR-T related cytokine expression
Time frame: Evaluate at 1, 2, 3 and 4 weeks after CAR-T infusion
Survival Rate (SR)
Survival Rate (SR)
Time frame: Evaluate at 6, 9, and 12 months
Time-To-Progression(TTP)
Time from the beginning of treatment to the progression of the disease
Time frame: Month 2,3,4,6,12,18and 24
Progression-free survival (PFS)
Assessment of PFS at Month 6,12,18and 24
Time frame: Month 6,12,18and 24
Duration of remission,DOR
The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion
Time frame: Up to 1 years after Treatment
Overall response rate,ORR
The proportion of patients with CR (complete remission) /CRi (complete remission with incomplete blood count recovery); The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).
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Time frame: Evaluate at 4, 8, and 12 weeks after CAR-T infusion
Clinical Benefit Rate(CBR)
ORR+MR
Time frame: Up to 24 weeks after Treatment
Disease Control Rate (DCR)
CBR+SD
Time frame: Up to 12 weeks after Treatment
Overall survival, OS
The time from CAR-T infusion to death due to any cause
Time frame: Up to 1 years after Treatment
Minimal Residual Disease
MRD in CR and sCR patients
Time frame: Up to 2 years after Treatment
Bone marrow transplantation STR
Monitoring the status of allogeneic hematopoietic stem cell transplantation using STR-PCR
Time frame: Evaluate at 4, 8,12,16 and 20 weeks after allogeneic hematopoietic stem cell transplantation