Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R/R T-LBL/ALL. (NCT07244380) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R/R T-LBL/ALL.
38 participantsStarted 2025-11-28
Plain-language summary
To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL/ALL.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1.The subject or guardian must provide voluntary informed consent; 2.Heavily pretreated patients with relapsed or refractory T-LBL/ALL who lack effective therapeutic alternatives; 3.At screening, CD7 positivity of tumor cells must be documented by flow cytometry (on bone marrow or peripheral blood samples) and/or by immunohistochemistry (IHC) confirming CD7 expression on an extramedullary lesion biopsy; 4.If malignant cells are detected in the peripheral blood at screening, they must demonstrate a CD4-negative and CD8-negative (double-negative) immunophenotype as assessed by flow cytometry; 5.Male or female subjects, aged 18 to 75 years (inclusive); 6.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; 7.Estimated survival time\>12 weeks.
Exclusion Criteria:
* 1.Patients with a history of allogeneic hematopoietic stem cell transplantation within the past 6 months are excluded; 2.Active or uncontrolled infection requiring systemic treatment at screening, excluding mild genitourinary and upper respiratory infections; 3.Participation in another clinical trial within 4 weeks prior to signing the informed consent form (ICF), OR the date of ICF signing occurring within 5 half-lives of the last dose from a previous investigational drug trial (whichever timeframe is longer); 4.Patients with previous treatment involving CAR-T cells or other gene-modified cell therapies are excluded; 5.Patients with acute GVHD (aGVHD) or moderate-to-severe c…
What they're measuring
1
Objective response rate after S101 infusion [Effectiveness]