Status:
RECRUITING
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
Lead Sponsor:
Beijing Tongren Hospital
Conditions:
B-cell Acute Lymphoblastic Leukemia
B-cell Lymphoma
Eligibility:
All Genders
14-85 years
Phase:
PHASE2
Brief Summary
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, we supp...
Eligibility Criteria
Inclusion
- 14 years to 85 years, expected survival \> 3 months;
- CD19/CD22 positive B-cell lymphoma or B-ALL;
- relapsed or refractory to standard first-line treatment;
- ECOG-PS score=0-2;
- Having at least one measurable lesions;
- Cardiac function: 1-2 levels;
- Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN;
- kidney: Cr≤1.25ULN;
- bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L;
- No serious allergic constitution;
- No other serious diseases that conflicts with the clinical program;
- No other cancer history;
- No serious mental disorder;
- Informed consent is signed by a subject or his lineal relation.
Exclusion
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B or hepatitis C infection;
- Recent or current use of glucocorticoid or other immunosuppressor;
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Participate in other clinical research in the past three months;
- previously treatment with any gene therapy products;
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06081478
Start Date
January 18 2022
End Date
December 31 2026
Last Update
October 13 2023
Active Locations (1)
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1
Liang Wang
Beijing, Beijing Municipality, China, 100730