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An open single arm clinical study of combination of CFR64 T and anti-CD20 monoclonal antibodies for relapsed and refractory B-cell lymphoma

An open single arm clinical study of combination of CFR64 T and anti-CD20 monoclonal antibodies for relapsed and refractory B-cell lymphoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060343
Enrollment
Unknown
Registered
2022-05-28
Start date
2022-05-16
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

B cell malignancies

Interventions

experimental group:CFR64 T + anti-CD20 monoclonal antibody

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 18-70 years old (including 18 and 70 years old); 2. Estimated survival time > 12 weeks; 3. B-cell lymphoma was diagnosed by pathological and histological examination, and the patient had relapsed or failed after receiving chemotherapy regimens containing CD20 monoclonal antibody; the patient voluntarily chose to infuse CFR64T cells combined with CD20 monoclonal antibody as salvage therapy; 4. Have measurable or evaluable lesions; 5. The main tissues and organs of the patient are in good function: (1) Liver function: ALT/AST = 95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >= 40%. 6. The peripheral superficial vein blood flow of the patient is smooth, which can meet the needs of intravenous infusion; 7. The patient's ECOG score is <= 2; 8. Patients or their legal guardians voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or women who have pregnancy plans within half a year; 2. Patients with active hepatitis B or C infection; 3. Patients with infectious diseases (such as HIV, active tuberculosis, etc.); 4. Patients who need anti infection treatment for systemic infection or local severe infection; 5. Patients with serious autoimmune diseases; 6. Patients with high allergic constitution or severe allergic history; 7. The patients with abnormal vital signs and unable to cooperate with the examination; 8. Patients with mental or psychological diseases who can not cooperate with treatment and efficacy evaluation; 9. The doctor thinks there are patients who cannot be included in the treatment for other reasons.

Design outcomes

Primary

MeasureTime frame
safety;

Secondary

MeasureTime frame
overall response rate;Progression-free survival;overall survival;

Countries

China

Contacts

Public ContactKailin Xu

Affiliated Hospital of Xuzhou Medical University

lihmd@163.com+86 15152166166

Outcome results

None listed

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