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Donor fully human CD19/CD22 dual target CAR T cells combined with allogeneic hematopoietic stem cell transplantation for the treatment of adult refractory/relapsed B-cell lymphoma. Single-center, open, non-randomized, single-arm clinical trial

Donor fully human CD19/CD22 dual target CAR T cells combined with allogeneic hematopoietic stem cell transplantation for the treatment of adult refractory/relapsed B-cell lymphoma. Single-center, open, non-randomized, single-arm clinical trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040665
Enrollment
Unknown
Registered
2020-12-07
Start date
2020-12-03
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

Adult refractory/relapsed B-cell lymphoma

Interventions

Experimental group:Reinfusion cell

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Patients who have been diagnosed with B-cell lymphoma and have relapsed after treatment with second-line or higher regimens (standard treatment including Rituxan and high-dose chemotherapy, or half a year after autologous hematopoietic stem cell transplantation), autologous CART cell therapy is invalid or the disease has progressed; 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 >=90 days; 6) Tumor tissue immunohistochemistry CD19 and CD22 are positive for one of the antigens or both; 7) The donor can collect enough lymphocytes and hematopoietic stem cells; 8) 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 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 organ transplantation (excluding autologous hematopoietic stem cell transplantation); 12) Female patients (patients with fertility) have a positive blood HCG test; 13) Active hepatitis (including positive copy number of hepatitis B DNA and hepatitis C RNA) and positive screening for AIDS and syphilis; 14) DSA (anti-donor specific antibody) is 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