Clinical Study of Senl-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ Acute T Lymphoblastic Leukemia and T Lymphoblastic Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is an open, prospective, dose-escalation clinical study to evaluate the safety and efficacy of Senl-T7 in patients with relapsed or refractory CD7+ acute T lymphoblastic leukemia or T lymphoblastic lymphoma.Meanwhile, PK/PD indexes of Senl-T7 were collected.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 70
Healthy Volunteers: f
View:

• Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred;

• CD7 expression in tumor cells was detected by flow cytometry;

• Life expectancy greater than 12 weeks;

• KPS or Lansky score≥60;

• HGB≥70g/L (can be transfused);

• 2-70 years old;

• Oxygen saturation of blood#90%#;

• HGB≥70g/L(blood transfusion allowed);

• Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;

⁃ Informed consent explained to, understood by and signed by patient/ guardian.

Locations
Other Locations
China
Hebei yanda Hospital
RECRUITING
Beijingcun
Contact Information
Primary
Xian Zhang
xian_zhang@126.com
008618611636172
Backup
Jianqiang Li, MD, PhD
limmune@gmail.com
008615511369555
Time Frame
Start Date: 2022-08-29
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 100
Treatments
Experimental: CD-7 CART
Patients will be treated with CD7 CAR-T cells
Sponsors
Leads: Hebei Senlang Biotechnology Inc., Ltd.

This content was sourced from clinicaltrials.gov