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A single center, single arm, open labelled study for CD20\CD22 Dual Specificity CART Cell Therapy on Relapsed/Refractory B cell Lymphoma or Leukemia

A single center, single arm, open labelled study for CD20\CD22 Dual Specificity CART Cell Therapy on Relapsed/Refractory B cell Lymphoma or Leukemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020021
Enrollment
Unknown
Registered
2018-12-11
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

Relapsed/Refractory B cell Lymphoma or Leukemia

Interventions

Case series:CD20\CD22 Dual Specificity CART Cell Therapy

Sponsors

Hematology Department, Xinhua Hospital, Affilated to Shanghai Jiaotong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 10-75 years old,Life expectation for more than 3 months; (2) Diagnosed as:relapsed/refractory B cell lymphoma or leukemia; (3) ECOG = 2; (4) Tumor burden:B-ALL,blast cells 92%; CBC results: wbc =2.5×10^9/L Hb = 80g/L, ALC > 0.5 × 10E9/L, Plt = 60×10^9/L; (6) Blood HCG test is negative within 7 days.Contraceptive measures should be performed during clinical study and 3 months post study; (7) Written informed consent could be acquired.

Exclusion criteria

Exclusion criteria: (1) Women in pregnancy and lactation; (2) Uncontrolled infection; (3) HIV positive; Active HBV or HCV infection; (4) Immunosuppressive agents or steroids in recent 1 week before recruitment; (5) Severe heart,liver,kidney diseases; (6) Received chemotherapy 1 month prior to lymphocyte collection or Received HSCT 3 months prior to lymphocyte collection; (7) Have participated similar trial within 3 months or other gene product treatment; (8) Poor transduction rate(<20%)or poor proliferation of lymphocyte; (9) leukemia CNS infiltration; (10) severe allergic reaction history; (11) other severe diseases such as autoimmune diseases,immune deficiency, organ transpant; (12) other malignant diseases history; (13) severe mental diseases history.

Design outcomes

Primary

MeasureTime frame
Safety and efficaty of CD20\CD22 dual specificity CART cell therapy on relapsed/refractory B cell lymphoma or leukemia;—

Secondary

MeasureTime frame
Rate of complete remission and patial remission of CD20\CD22 dual specificity CART cell therapy on relapsed/refractory B cell lymphoma or leukemia;—

Countries

China

Contacts

Public ContactSiguo Hao

Hematology Department, Xinhua Hospital, Affilated to Shanghai Jiaotong University, School of Medicine

haosghj88@hotmail.com+86 021-25077600

Outcome results

None listed

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