Experimental 'Super-Universal' immune cells take on tough blood cancers
NCT ID NCT07153068
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a new type of immune cell therapy called supCD7 CART cells in 12 adults with relapsed or refractory CD7-positive blood cancers (T-cell leukemia/lymphoma or acute myeloid leukemia). The cells are designed to target and kill cancer cells that carry the CD7 protein. Participants will receive chemotherapy before the cell infusion. The main goals are to check safety and see if the treatment can shrink or eliminate the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- super-universal CD7 CART cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could offer a new treatment option for people with hard-to-treat blood cancers that have come back after other therapies.
- What could go wrong
- This is a very early, small trial (only 12 people) to test safety and dosing. It may not work for everyone, and there are risks like severe immune reactions or side effects from the chemotherapy given beforehand.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 complete remission and fail to achieve complete remission induced by 1 or more cycles of standard treatment; c. Relapse after hematopoietic stem cell transplantation or relapse after CAR-T therapy at the same target; * Complies with diagnosis of other relapsed/refractory CD7 positive hematologic malignancies * Creatine clearance \>60ml/min (Cockcroft and Gault formula); 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; * showing left ventricular ejection fraction (LVEF) ≥50%; * Pulse oxygen saturation ≥92%; * The estimated survival time is more than 3 months; * score 0-2; * Subjects or their legal guardians voluntarily participate in this trial and sign the informed consent form. Exclusion Criteria: Subjects who met any of the following criteria were excluded from the study: * acute promyelocytic leukemia (APL); * Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure; * Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3; * Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met: a. Systemic chemotherapy (except for pretreatment) within 1 week; b. 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; c. Received donor lymphocyte infusion (DLI) within 6 weeks; * Presence of uncontrolled, serious, active infection at screening; * Patients with a history of serious heart disease, including: severe cardiac insufficiency (subjects with cardiac insufficiency of Class III or IV according to the New York Heart Association (NYHA) cardiac function classification standard), myocardial infarction within 12 months or cardiac angioplasty or stenting, unstable angina pectoris, ECG indicating significant QT interval prolongation (\>480ms) or serious arrhythmia judged by the investigator; * Previous craniocerebral trauma, disturbance of consciousness, epilepsy, cerebral ischemia, cerebral vascular hemorrhagic disease and other medical history, and within six months of the need for drug treatment; * Patients with hepatitis B surface antigen (HBsAg) greater than 10E6 IU/mL, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis antibody test positive, EBER positive or EBV copy number greater than the upper limit of normal at screening; * Patients who must use steroid hormones during CAR-T infusion (except for local or inhaled steroid hormones); subjects who are receiving systemic steroid therapy before screening and need long-term systemic steroid therapy during treatment according to the investigator's judgment (except for inhaled or local use); * Subjects with autoimmune diseases requiring treatment, immunodeficient subjects, or subjects requiring immunosuppressive treatment; * Patients with acute graft-versus-host disease (GvHD) or moderate-to-severe chronic GvHD within 4 weeks prior to screening; * Patients with a history of allergy to any component of cell products; * Pregnant, lactating females, and subjects (male or female) of childbearing potential who are unable to use effective contraception within 1 year after cell infusion; male subjects who plan to become pregnant within 1 year after cell infusion; female subjects or partners who plan to become pregnant within 1 year after cell infusion; * Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital
RECRUITINGTianjin, Tianjin Municipality, China
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