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Phase II clinical study of sequential treatment of relapsed and refractory aggressive B-cell lymphoma with CART cells with different B-cell targets

Phase II clinical study of sequential treatment of relapsed and refractory aggressive B-cell lymphoma with CART cells with different B-cell targets

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055062
Enrollment
Unknown
Registered
2021-12-31
Start date
2021-12-31
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Relapsed and refractory aggressive B-cell lymphoma

Interventions

experimental group:Sequential therapy of CART cells with different B cell targets

Sponsors

Beijing Boren Hospital Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Relapsed or refractory aggressive B-cell lymphoma diagnosed with positive target markers (lymphoma cells express therapeutic target antigens, such as CD19, CD22, CD20) (standards refer to NCCN Guidelines, 5th edition in 2017); relapsed aggressive B-cell lymphoma refers to patients with aggressive B-cell lymphoma whose tumor burden increased again after reaching CR, refractory aggressive B-cell lymphoma refers to patients with aggressive B-cell lymphoma who have not achieved CR after 4 courses of standard chemotherapy; 2. The patient must have evidence of evaluable disease, including minimal residual disease; 3. Aged 18-75 years, including boundary values; 4. The expected survival period is more than 3 months; 5. ECOG score 0-2 points; 6. Women of childbearing age who have a negative blood pregnancy test before the start of the trial and who agree to take effective contraceptive measures during the trial until the last follow-up.

Exclusion criteria

Exclusion criteria: 1. Primary central nervous system aggressive B-cell lymphoma or aggressive B-cell lymphoma involving the central nervous system; 2. Those with a history of epilepsy or other central nervous system diseases; 3. Active hepatitis B or hepatitis C virus infection, HIV, cytomegalovirus, EB virus infection or other uncured active infection; 4. Lactating patients; 5. Those who have used any gene therapy products before; 6. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.

Design outcomes

Primary

MeasureTime frame
Efficacy evaluation index;

Countries

China

Contacts

Public ContactHu Kai

Beijing Boren Hospital

xiaohu7079@sina.com+86 15010390336

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026