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 (Jun 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
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD7 positive (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT07280494 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational drug, extensive radiotherapy, systemic corticosteroids or other immunosuppressive drugs disqualifies patients from enrollment.
Does this trial require CD7?
Yes, CD7 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger and at least 3 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages