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A phase I clinical study of donor CD7 CART cells in the treatment of refractory and relapsed T lymphoblastic lymphoma in children and adolescents

A phase I clinical study of donor CD7 CART cells in the treatment of refractory and relapsed T lymphoblastic lymphoma in children and adolescents

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045863
Enrollment
Unknown
Registered
2021-04-25
Start date
2021-04-30
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Refractory and relapsed T lymphoblastic lymphoma

Interventions

Treatment group:Cell reinfusion

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1-18 years (including 18 years old); 2. Pathologically diagnosed as CD7-marked positive T lymphoblastic lymphoma; 3. Primary drug resistance, tumor progression and recurrence during chemotherapy, or tumor recurrence after stopping the drug, and second-line chemotherapy failure; recurrence after allogeneic hematopoietic stem cell transplantation; 4. ECOG score 0-2 points; 5. Estimated survival time >= 60 days; 6. Appropriate sibling donors who are fully compatible, non-consanguinous fully compatible or semi-compatible donors; 7. Self-knowledgeable patients who aged >= 8 years voluntarily sign the informed consent form, and the legal representative (guardian) of the child patient under 8 years old voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. High tumor burden, extensive involvement, and corresponding complications, which affect the normal function of organs, such as: hyperleukocytosis, medium and large serous cavity effusion, severe hypoproteinemia, severe electrolyte imbalance, acid-base balance imbalance, Blood coagulation dysfunction, significantly enlarged liver and spleen, etc.; 2. Giant tumors compress surrounding tissues and organs, causing obvious complications, such as: airway compression or obstruction, superior vena cava obstruction syndrome, gastrointestinal obstruction, etc.; 3. Central nervous system invasion with obvious intracranial hypertension; 4. Combined with severe tumor lysis syndrome; 5. Combined with hemophagocytic syndrome; 6. Symptomatic heart failure or severe arrhythmia caused by various reasons; 7. Patients who are suffocated and have difficulty breathing due to various reasons; 8. Acute liver and kidney failure caused by various reasons; 9. Coagulation dysfunction with bleeding caused by various reasons; 10. Suffer from sepsis or other infections that are difficult to control; 11. Suffer from uncontrollable diabetes; 12. Severe mental disorder; 13. Have received an organ transplant (excluding bone marrow transplant); 14. Pstients who suffer from graft-versus-host disease or need to use immunosuppressive agents; 15. Donor CD7CART cell therapy to unconditionally bridge transplant recipients; 16. With other types of malignant tumors; 17. Female patients (patients with fertility) have a positive blood HCG test.

Design outcomes

Primary

MeasureTime frame
Safety index;Curative effect index;Pharmacokinetic index;

Countries

China

Contacts

Public ContactZhang Yonghong

Beijing Boren Hospital Co., Ltd.

zhangyongh@gobroadhealthcare.com+86 10 83605200-502

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026