OncoMatch/Clinical Trials/NCT07280494
To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT
Is NCT07280494 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CAR-T Therapy for cd7+ t-all/lbl.
Treatment: CAR-T Therapy — To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of T-lymphoblastic leukaemia/lymphoma with postive measurable residual disease positive post allogeneic stem cell transplantation
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD7 positive (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: allogeneic hematopoietic stem cell transplant
MRD Positive T-ALL/LBL Post Allo-HSCT
Cannot have received: investigational drug
Exception: bridging chemotherapy due to large tumor burden or rapid disease progression
Received any investigational drug treatment or other systemic anti-tumor treatment within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is judged more appropriate by the investigator), except for bridging chemotherapy due to large tumor burden or rapid disease progression
Cannot have received: extensive radiotherapy
Exception: local radiotherapy for symptom relief of non-target lesions during the study period
Received extensive radiotherapy within 4 weeks before signing the ICF, except for local radiotherapy for symptom relief of non-target lesions during the study period
Cannot have received: systemic corticosteroids or other immunosuppressive drugs
Exception: intranasal, inhaled, topical steroids or local steroid injections; systemic corticosteroids at a dose not exceeding 10 mg/day of prednisone or its equivalent physiological dose; steroids as prophylactic treatment for allergic reactions; for the treatment of adverse reactions after reinfusion
Received systemic corticosteroids (dose equivalent to or higher than 10 mg/day of prednisone) or other immunosuppressive drugs within 3 days before apheresis or during the study period, except for the following situations: 1. Intranasal, inhaled, topical steroids or local steroid injections (such as intra-articular injections); 2. Systemic corticosteroids at a dose not exceeding 10 mg/day of prednisone or its equivalent physiological dose; 3. Steroids as prophylactic treatment for allergic reactions (such as pre-treatment before computed tomography [CT]); 4. For the treatment of adverse reactions after reinfusion.
Cannot have received: major surgery
Exception: routine biopsy surgeries excluded
Received major surgery within 4 weeks before signing the ICF (routine biopsy surgeries excluded), or expected to undergo major surgery during the study period
Lab requirements
Kidney function
For adults: creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault) or serum creatinine ≤ 1.5× ULN; for children: age-specific creatinine thresholds
Liver function
AST and ALT ≤ 5× ULN; total bilirubin ≤ 2× ULN
Cardiac function
QTc < 480 ms (Fridericia); NYHA class < II; LVEF ≥ 50%; no unstable angina or acute MI within 6 months; no uncontrolled hypertension; no clinically significant or antiarrhythmic-requiring arrhythmias
Major organ functions must meet the following requirements: AST and ALT ≤ 5× ULN; total bilirubin ≤ 2× ULN; For adult subjects, the serum creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault formula) or serum creatinine ≤ 1.5× ULN; for children, the serum creatinine should be no more than 0.8 mg/dL for 2 to 6 years old, 1.0 mg/dL for 6 to 10 years old, 1.2 mg/dL for 10 to 13 years old, 1.5 mg/dL for 13 to 16 years old males, and 1.4 mg/dL for females over 13 years old; for males over 16 years old, it should be no more than 1.7 mg/dL. If the above organ function abnormalities are caused by infiltration of the primary disease, the decision on whether to include the subject in the study is made by the investigator. QTc < 480 ms (Fridericia); NYHA class < II; LVEF ≥ 50%; no unstable angina or acute MI within 6 months; no uncontrolled hypertension; no clinically significant or antiarrhythmic-requiring arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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