OncoMatch/Clinical Trials/NCT07109518
uCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
Is NCT07109518 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies uCD7 CART for acute myeloid leukemia (aml).
Treatment: uCD7 CART — The aim of this study was to evaluate the safety and efficacy of universal CD7 CART (uCD7 CART) cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase 1 clinical trial, two cohorts were set up: (1) relapsed and refractory acute myeloid leukemia (AML) cohort; and (2) relapsed and refractory T lymphoblastic leukemia/lymphoma (T-ALL/LBL) cohort. Each cohort was planned to enroll 4-12 patients. uCD7 CART cells will be administered intravenously to explore the maximum tolerated dose (MTD) of each cohort using a 3+3 dose escalation and rapid titration design.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD7 overexpression (positive)
Cytology confirmed that the tumor cells were CD7 positive.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: systemic chemotherapy
Exception: except for pretreatment; within 1 week
Systemic chemotherapy (except for pretreatment) within 1 week
Cannot have received: monoclonal antibody therapy
Exception: last infusion less than 5 half-lives or 4 weeks (whichever is shorter) at screening
For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening
Cannot have received: donor lymphocyte infusion
Exception: within 6 weeks
Received donor lymphocyte infusion (DLI) within 6 weeks
Lab requirements
Kidney function
creatine clearance >60ml/min (cockcroft and gault formula)
Liver function
serum total bilirubin ≤3 times the upper limit of normal, serum alt and ast ≤5 times the upper limit of normal range for patients without liver invasion
Cardiac function
echocardiography showing left ventricular ejection fraction (lvef) ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07109518 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy, monoclonal antibody therapy, donor lymphocyte infusion 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 70 years or younger.
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