Anti-CD7 CAR-T cell therapy for relapsed or refractory CD7 positive blood cancers

Clinical Trial for the Safety and Efficacy of Anti-CD7 Chimeric Antigen Receptor Cell Therapy for Patients With Relapsed or Refractory CD7 Positive Hematological Malignancy

This study is testing a new CAR-T cell therapy for people with certain types of blood cancers that haven't responded to other treatments to see if it can help them.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 3 Years to 80 Years
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, CAR-T
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT04599556 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of anti-CD7 CAR-T cell therapy in patients with relapsed or refractory CD7 positive hematological malignancies, specifically targeting CD7+ acute leukemia and lymphoma. It is a prospective, open-label, single-center study that focuses on measuring dose limiting toxicity and treatment emergent adverse events. The trial aims to provide a new treatment option for patients who have not responded to standard chemotherapy.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with relapsed or refractory CD7 positive T-ALL/LBL or T-NHL who meet specific health criteria.

Not a fit: Patients with active pulmonary infections or those with a life expectancy of less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a new hope for patients with difficult-to-treat CD7 positive blood cancers.

How similar studies have performed: Other studies have shown promise with CAR-T cell therapies, particularly in hematological malignancies, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L;
2. Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
3. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
4. The estimated survival time is more than 3 months;
5. ECOG score was 0-2;
6. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

For T-ALL/LBL:

1. Patients is histologically diagnosed with CD7 Positive T-ALL/LBL according to the Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (ALL) (2020. V1) by National Comprehensive Cancer Network (NCCN).
2. The diagnosis is consistent with r/r CD7 + T-ALL/LBL, and includes any of the following conditions:

   1. No CR was obtained by standard chemotherapy;
   2. The first induction was CR, but the duration of CR was less than 12 months;
   3. No CR was obtained after the first or multiple remedial treatment;
   4. Relapse twice or more;
3. The number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry).

For T-NHL:

1. Patients is histologically diagnosed with CD7 Positive T-NHL according to The 2016 revision of the World Health Organization classification of lymphoid neoplasms.
2. r/r T-NHL, and includes any of the following conditions:

   1. No response or relapse after second or more lines of chemotherapy;
   2. Primary refractory ot chemotherapy;
   3. Relapse after autologous stem cell transplantation;
3. According to the Lugano 2014 criteria, there is at least one evaluable tumor lesion.

For AML:

1. Patients is histologically diagnosed with CD7 Positive AML according to the Clinical Practice Guidelines for Acute Myeloid Leukemia (AML) (2020. V3) by National Comprehensive Cancer Network (NCCN).
2. The diagnosis is consistent with r/r CD7 + AML, and includes any of the following conditions:

   1. No CR was obtained by standard chemotherapy;
   2. The first induction was CR, but the duration of CR was less than 12 months;
   3. No CR was obtained after the first or multiple remedial treatment;
   4. Relapse twice or more;
3. The number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry).

Exclusion Criteria:

1. Patients with history of epilepsy or other central nervous system diseases;
2. Patients with prolonged QT or severe heart disease;
3. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
4. The patients with uncontrolled active infection;
5. Active hepatitis B or hepatitis C virus infection;
6. Previous application of gene therapy;
7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
8. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
9. Those who suffer from other uncontrolled diseases are not suitable to join the study;
10. HIV infection;
11. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital，College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yongxian Hu

Conditions CD7+ Acute Leukemia; CD7+ Lymphoma