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A single-center, open, non-randomized, single-arm clinical trial of donor CD7-CAR T cells in the treatment of refractory/relapsed acute T lymphoblastic leukemia

A single-center, open, non-randomized, single-arm clinical trial of donor CD7-CAR T cells in the treatment of refractory/relapsed acute T lymphoblastic leukemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034762
Enrollment
Unknown
Registered
2020-07-18
Start date
2020-07-17
Completion date
Unknown
Last updated
2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory/relapsed acute T lymphoblastic leukemia

Interventions

Case series:Intravenous CD7 CAR T cells

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 70 Years

Inclusion criteria

Inclusion criteria: 1) Acute T lymphocytic leukemia patients diagnosed with primary drug resistance on the expression of the tumor surface antigen CD7, recurrence of chemotherapy, persistent residual positive or relapse/refractory after allogeneic hematopoietic stem cell transplantation; 2) Male or female patients, aged 0-70 years old; 3) No severe allergies; 4) Physical fitness score 0-2 points; 5) Estimated survival time >=60 days; 6) Bone marrow or peripheral blood or immunohistochemical CD7 positive; 7) Self-knowledgeable patients aged 8-70 voluntarily sign an informed consent form, and the legal representative (guardian) of a child patient under 18 voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Intracranial hypertension or brain consciousness disorder; 2) Symptomatic heart failure or severe arrhythmia; 3) Symptoms of severe respiratory failure; 4) With other types of malignant tumors; 5) Diffuse intravascular coagulation; 6) Serum creatinine and/or urea nitrogen >=1.5 ULN; 7) Suffer from sepsis or other infections that are difficult to control; 8) Suffer from uncontrollable diabetes; 9) Severe mental disorder; 10) There are obvious intracranial lesions in head MRI examination; 11) Have received an organ transplant (excluding bone marrow transplant); 12) Female patients (patients with fertility) have a positive blood HCG test; 13) Hepatitis (including hepatitis B and C), AIDS and syphilis screening positive. volume_up content_copy share

Design outcomes

Primary

MeasureTime frame
Safety evaluation index;Evaluation index of pharmacokinetics;Efficacy evaluation index;

Countries

China

Contacts

Public ContactJing Pan

Beijing Boren Hosptal

panj@borenhospital.com+86 18911067969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026