Recruiting

Super-universal CD7 CART Cells for CD7 Positive Hematologic Malignancies

Study Aim

The study aims to evaluate the safety and effectiveness of Super-universal CD7 CART Cells in adults with CD7 positive blood cancers.

What is being tested

supCD7 CART cells

Biological

Who is being recruted

Hematologic Diseases+9

+ Hemic and Lymphatic Diseases

+ Immune System Diseases

From 18 to 70 Years

+28 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: June 2025

See protocol details

Summary

Principal SponsorInstitute of Hematology & Blood Diseases Hospital, China

Study ContactJianxiang Wang

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 28, 2025

Actual date on which the first participant was enrolled.

This clinical study focuses on using a special type of immune cell treatment called super-universal CD7 CART cells to help people with certain blood cancers that have returned or are not responding to treatment. The study specifically targets patients with relapsed or refractory acute myeloid leukemia (AML) and T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL) that are CD7 positive. The hope is that this new treatment can offer a more effective option for patients who have limited choices due to the aggressive nature of their disease. Participants in the study will receive an infusion of supCD7 CART cells after undergoing a pre-treatment regimen with medications called fludarabine and cyclophosphamide, which prepare the body for the CART cells. The study explores different doses of these cells to find the safest and most effective amount. Researchers will closely observe participants to assess the treatment's safety and effectiveness. This includes monitoring for any side effects and measuring how well the cancer responds to the treatment.

Official TitleSuper-universal CD7 CART (supCD7 CART) Cell Injection in the Treatment of Relapsed or Refractory CD7 Positive Hematologic Malignancies: a Prospective, Single-arm, Single-center Clinical Study.

NCT07153068

Principal SponsorInstitute of Hematology & Blood Diseases Hospital, China

Study ContactJianxiang Wang

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, MyeloidLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLeukemia, Myeloid, Acute

Criteria

14 inclusion criteria required to participate

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;

score 0-2;

Cytology confirmed that the tumor cells were CD7 positive.

showing left ventricular ejection fraction (LVEF) ≥50%;

Show More Criteria

14 exclusion criteria prevent from participating

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;

acute promyelocytic leukemia (APL);

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;

Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

This study will employ supCD7 CART cells to treat CD7-positive relapsed or refractory hematologic malignancies, particularly in patients with AML and T-ALL/LBL, with the aim of improving the re-remission rate in AML and T-ALL/LBL and providing a new therapeutic option to enhance their long-term survival.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Institute of Hematology & Blood Diseases Hospital

Tianjin, ChinaOpen Institute of Hematology & Blood Diseases Hospital in Google Maps

Recruiting

One Study Center