OncoMatch/Clinical Trials/NCT06064903
CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL
Is NCT06064903 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies CD7-CART01 for t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma.
Treatment: CD7-CART01 — The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD7 overexpression (>98% CD7 expression on blast cells)
Diagnosis of CD7 expressing (> 98% CD7 expression on blast cells) T-ALL or LL
Demographics
Prior therapy
Must have received: standard frontline chemotherapy
Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement
Cannot have received: systemic steroids
Exception: inhaled/topical/non-absorbable steroids and physiologic replacement doses allowed if no increase in dose for at least 2 weeks prior to apheresis/infusion
Systemic steroids (at a dose equivalent to or greater than 2 mg/kg prednisone) in the 2 weeks before apheresis collection / Systemic steroids (at a dose > 2 mg/kg prednisone) in the 2 weeks before infusion
Cannot have received: systemic chemotherapy
Exception: no waiting period for patients relapsing on standard ALL maintenance chemotherapy
Systemic chemotherapy in the 2 weeks preceding apheresis collection / infusion
Cannot have received: nelarabine (nelarabine)
Nelarabine exposure in the 3 weeks preceding apheresis collection
Cannot have received: daratumumab (daratumumab)
daratumumab exposure in the 3 weeks preceding apheresis collection
Cannot have received: clofarabine (clofarabine)
clofarabine exposure in the 3 weeks preceding apheresis collection
Cannot have received: anti-thymocyte globulin (anti-thymocyte globulin, alemtuzumab)
Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding apheresis collection / infusion
Cannot have received: immunosuppressive agents
Immunosuppressive agents in the 2 weeks preceding apheresis collection / infusion
Cannot have received: radiation therapy
Radiation therapy must have been completed at least 2 weeks prior to apheresis / at least 3 weeks prior to enrollment
Cannot have received: anti-neoplastic investigational agents
Other anti-neoplastic investigational agents currently administered or within 30 days prior to apheresis / infusion
Lab requirements
Kidney function
serum creatinine ≤ 3x ULN for age
Liver function
total bilirubin ≤ 4x ULN; ALT and AST ≤ 6x ULN
Cardiac function
Left ventricular ejection fraction ≥ 45% by ECHO; no congestive heart failure or cardiac arrhythmia
Hepatic function: Inadequate liver function defined as total bilirubin > 4x ULN or transaminase (ALT and AST) > 6 x ULN. Renal function: serum creatinine > 3x ULN for age. Cardiac function: Left ventricular ejection fraction lower than 45% by ECHO. Congestive heart failure, cardiac arrhythmia [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06064903 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic steroids, systemic chemotherapy, nelarabine disqualifies patients from enrollment.
Does this trial require CD7?
Yes, CD7 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 25 years or younger and at least 0 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 qualify