Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell in Patients With Relapsed/Refractory Acute Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Acute leukemia is a malignant clonal disease of hematopoietic stem cells. At present, the treatment for acute leukemia is relatively limited, and it is still based on high-intensity chemotherapy drug therapy and hematopoietic stem cell transplantation. The prognosis of recurrent and refractory acute leukemia is poor, and there is a lack of effective treatment plan. CD7 is a specific target on the surface of T cells, and CD7 CAR-T is expected to provide a new therapeutic path for patients with relapsed refractory acute leukemia.This is an open, single-arm, single-center, prospective clinical study. The main objective of the clinical study is to evaluate the clinical safety and tolerability of CD7 CAR-T in the treatment of acute leukemia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients diagnosed with acute leukemia.

• Acute leukemia complex/refractory cases with poor response to conventional chemotherapy: 1) patients who did not achieve complete remission after 2 courses of treatment with standard induced remission regimen; 2) Recurrence within 6 months after the first remission; 3) Relapse 6 months after the first remission, but failure to be treated again with the original induced remission regimen; 4) Recurrent patients.

• At least 2 weeks or 5 half-lives (whichever is shorter) from the start of preconditioning chemotherapy after prior systemic treatment, except for immune checkpoint inhibitors/agonists; Systemic immune checkpoint inhibitor/agonist treatment is at least 3 half-lives away from pre-treatment chemotherapy (e.g., ipilimumab, etc.).

• Toxic reactions caused by previous antitumor therapy must be stabilized and returned to ≤ grade 1 (except for clinically insignificant toxicity, such as baldness).

• Over 14 years old, under 65 years old.

• Physical Strength score 0-3 (ECOG standard)

• No obvious active infection or graft-versus-host disease

• Expected survival ≥3 months

• Adequate kidney, liver, lung and heart function, defined as:

• Creatinine clearance (estimated by Cockcroft Gault formula) \> 60 mL/min; Serum ALT/AST ≤ 2.5 ULN; Total bilirubin ≤1.5 ULN, excluding subjects with Gilbert's syndrome; Cardiac ejection fraction ≥ 50%, echocardiography confirmed centropericardial effusion, and ECG showed no clinically significant abnormal findings.

• There was no clinically significant pleural effusion. Baseline blood oxygen saturation under indoor ventilation was \> 92%.

⁃ The serum pregnancy test results of fertile women must be negative (women who have undergone surgical sterilization or at least 2 years after menopause are considered to be infertile).

Locations
Other Locations
China
The General Hospital of Western Theater Command
RECRUITING
Chengdu
Contact Information
Primary
Hai Yi, Ph.D
yihaimail@163.com
0086-28-86571279
Backup
Sihan Lai
laisihan@163.com
0086-28-86571279
Time Frame
Start Date: 2024-02-18
Estimated Completion Date: 2030-11-01
Participants
Target number of participants: 200
Treatments
Experimental: Experimental group
CD7 positive relapsed or refractory acute leukemia
Related Therapeutic Areas
Sponsors
Leads: The General Hospital of Western Theater Command
Collaborators: YakeBiotech Ltd.

This content was sourced from clinicaltrials.gov

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