SupCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies (NCT07153068) | Clinical Trial Compass
RecruitingPhase 1/2
SupCD7 CART for Relapsed or Refractory CD7 Positive Hematologic Malignancies
China12 participantsStarted 2025-06-28
Plain-language summary
The aim of this study was to evaluate the safety and efficacy of supCD7 CART cells in the treatment of patients with relapsed/refractory CD7-positive hematologic malignancies. In this single-arm, open-label, single-center, Phase â… +â…¡ clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory T-ALL/LBL cohort. Each cohort was planned to enroll 4-12 patients. SupCD7 CART cells will be administered intravenously to explore the MTD of each cohort using a 3+3 dose escalation and rapid titration design.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Age ≥18 and \<70 years, regardless of gender;
* T-ALL/LBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and T-cell Lymphoma Clinical Practice Guidelines (2020.v1);
* Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission;
* Cytology confirmed that the tumor cells were CD7 positive.
* Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);
* Complies with the diagnosis of relapsed/refractory AML, including any of the following conditions according to China Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2021 Edition): a. Primary refractory patients who did not achieve CR after two cycles of standard induction chemotherapy; b. CR after consolidation chemotherapy, relapse within 12 months; c. Relapse 12 months after remission but ineffective after conventional chemotherapy; d. 2 or more relapses; e. Relapse after hematopoietic stem cell transplantation.
* Meet the diagnosis of relapsed/refractory T-ALL/LBL, including any of the following: a. Primary refractory patients who have not achieved complete response after two cycles of standard chemotherapy, or patients who have not achieved complete response after multi-line rescue chemotherapy; b. Relapse within \<12 months after complete remission or ≥12 months after comple…
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Efficacy will be evaluated at Weeks 4, 8, and 12 following supCD7 CART cell infusion.
Trial details
NCT IDNCT07153068
SponsorInstitute of Hematology & Blood Diseases Hospital, China