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 Ⅰ+Ⅱ 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 range
18 Years – 70 Years
Sex
ALL
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:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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