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Fully human CD7 CART cells from related donors combined with allogeneic hematopoietic stem cell transplantation for the treatment of refractory/relapsed T lymphoblastic lymphoma/leukemia in adults: single-center, open, non-randomized, single-arm clinical trial

Fully human CD7 CART cells from related donors combined with allogeneic hematopoietic stem cell transplantation for the treatment of refractory/relapsed T lymphoblastic lymphoma/leukemia in adults: single-center, open, non-randomized, single-arm clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043252
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-01-27
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Adult refractory/relapsed T lymphoblastic lymphoma/leukemia

Interventions

therapy group :Reinfusion cell

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) T lymphoblastic lymphoma/leukemia is diagnosed, no remission or recurrence after standard second-line and above chemotherapy (including those with positive bone marrow residual), and half a year after autologous hematopoietic stem cell transplantation or 1 year after allogeneic hematopoietic stem cell transplantation Relapsed patients; 2) Male or female patients, aged 18-60 years (including 18 years old); 3) No severe allergies; 4) Physical fitness score 0-2 points; 5) The estimated survival period is >= 120 days; 6) The tumor tissue immunohistochemical CD7 antigen is positive; 7) Relative donors can collect enough lymphocytes and hematopoietic stem cells; 7) The patient voluntarily signed 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 times the normal value; 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 organ transplantation (excluding autologous hematopoietic stem cell transplantation); 12) Female patients (patients with fertility) have a positive blood HCG test; 13) Hepatitis (including hepatitis B and C), AIDS and syphilis screening positive; 14) Those who are positive for blood CMV-DNA or blood EBV-DNA; 15) DSA (anti-kin donor specific antibody) positive.

Design outcomes

Primary

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

Countries

China

Contacts

Public ContactTong Wu

Beijing Boren Hospital

wut@gobroadhealthcare.com+86 13801044860

Outcome results

None listed

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