Treatment of CD7-positive blood cancers using CAR-T cells
An Open-label Clinical Study on the Efficacy and Safety of CD7-specific CAR-T Cell Injection in the Treatment of CD7-positive Relapsed/Refractory Hematologic Tumors
This study is testing a new CAR-T cell therapy designed to target CD7 in patients with certain blood cancers that haven't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 3 Years to 75 Years |
| Sex | All |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Academic / other |
| Drugs / interventions | chemotherapy, CAR-T, CART |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06720324 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of CD7-specific CAR-T cell therapy in patients with relapsed or refractory hematologic tumors. It is a single-center, open-label study that utilizes a lentiviral CAR structure to create CAR-T cells that specifically target CD7 while avoiding self-destruction. The trial will also collect pharmacokinetic and pharmacodynamic data to better understand the behavior of these CAR-T cells in the body.
Who should consider this trial
Good fit: Ideal candidates are patients with relapsed or refractory hematologic malignancies that express CD7 and have not responded to standard treatments.
Not a fit: Patients with hematologic tumors that do not express CD7 or those who have not undergone prior standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat CD7-positive hematologic malignancies.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating potential success for this novel approach targeting CD7.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Subjects with a diagnosis of relapsed/refractory hematologic malignancies that meet any of the following criteria:
1. Recurrence: peripheral blood or bone marrow blasts (proportion\>5%) after achieving complete remission after previous standard treatment regimens, or extramedullary disease, including:
i) Early recurrence within 12 months; ii) Late recurrence of 12 months or more with no remission after one course of standard induction chemotherapy; iii) Relapse after autologous or allogeneic hematopoietic stem cell transplantation.
2. Refractory: complete remission is not achieved after at least two courses of standard induction therapy, or complete remission is not achieved after first-line or above salvage therapy
* At the time of enrollment screening, bone marrow flow cytometry detected tumor cells as CD7 expression and/or pathological immunohistochemistry of extramedullary lesions was confirmed that tumor cells expressed CD7.
* If tumor cells are detected in peripheral blood during enrollment screening, the immunophenotype of tumor cell surface at the time of flow cytometry detection should be CD4 and CD8 negative. If the surface immunophenotype of peripheral blood tumor cells is not CD4 and CD8 negative, the condition of ≤1% proportion of peripheral blood tumor cells must be met.
* Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to 2.
* Expected survival over 3 months;
* Liver, kidney and cardiopulmonary functions meet the following requirements:
1. Serum creatinine ≤ 1.5× ULN；
2. Left ventricular ejection fraction (LVEF) ≥50%;
3. Baseline peripheral oxygen saturation \> 90%;
4. Total bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN.
* Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
Exclusion Criteria:
* Appearance of one of the following cardiac criteria: atrial fibrillation; myocardial infarction in the last 12 months; prolonged QT syndrome or secondary QT extension, as judged by the investigator.
Echocardiography LVSF \<30% or LVEF \<50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (confirmed by echocardiography within 12 months of treatment).
* Active GVHD.
* History of severe pulmonary function impairment disease.
* Other malignant tumors in the advanced stage.
* Severe infection or persistent infection that cannot be effectively controlled.
* Combined with severe autoimmune disease or innate immune deficiency.
* Active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBV-DNA 500 IU / ml and abnormal liver function\] or hepatitis C antibody \[HCV-Ab\] positive, HCV-RNA above the lower limit of detection of the analytical method and abnormal liver function).
* Human immunodeficiency virus (HIV) infection or syphilis infection.
* History of severe allergies to biological products (including antibiotics).
* Central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, etc..
* Female patients are in pregnancy and lactation, or have a pregnancy plan within 12 months.
* Situations where the investigator may increase the risk or interfere with the test results.
Where this trial is running
Wuhan, Hubei
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Mei Heng, M.D., Ph.D — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study coordinator: Mei Heng, M.D., Ph.D
- Email: hmei@hust.edu.cn
- Phone: 027-8572600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.