Hematological Malignancies
Conditions
Keywords
T-ALL/LBL, AML
Brief summary
This is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.
Interventions
DRUGAnti-CD7 CAR-T
Universal CAR-T cells targeting CD7
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed CD7 positive relapsed/refractory hematological malignancies. 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. Eastern cooperative oncology group (ECOG) performance status of 0 to 2 6. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
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 4. Patients with uncontrolled active infection. 5. Positive for any of the following etiological tests: HIV, HBV, HCV 6. Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate(ORR) | 1 Year | Number of patients who achieved response after treatment of CD7 CAR-T cell. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of overall response (DOR) | 1 Year | Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up. |
| Overall survival(OS) | 1 Year | OS will be assessed from the CAR-T cell infusion to death or last follow-up. |
Countries
China
Outcome results
None listed