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Trial Title:
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
NCT ID:
NCT06081478
Condition:
B-cell Acute Lymphoblastic Leukemia
B-cell Lymphoma
Diffuse Large B Cell Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CD19/CD22-bispecific CAR-T cells
Description:
CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and
1×10e6/kg dosage, respectively.
Arm group label:
CD19/CD22 CAR-T group
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 supposed that CD19/CD22 bispecific CAR-T cell therapy would be more
effective and less relapses would occur in B-ALL or NHL. In this prospective phase 2
clinical trial, we aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T
cell therapy in relapsed/refractory B-ALL or Large B cell lymphoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender:
All
Minimum age:
14 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Liang Wang
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang Wang, M.D.
Phone:
+8615001108693
Email:
wangliangtrhos@126.com
Investigator:
Last name:
Liang Wang, M.D.
Email:
Principal Investigator
Start date:
January 18, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Beijing Tongren Hospital
Agency class:
Other
Source:
Beijing Tongren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081478
