B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma, Diffuse Large B Cell Lymphoma
Conditions
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 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.
Interventions
DRUGCD19/CD22-bispecific CAR-T cells
CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best ORR | From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion | Overall response rate means sum of complete response rate and partial response rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best CR rate | From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion | CR was defined as complete remission evaluated using PET-CT scan or BM test |
| Progression free survival (PFS) | From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion | PFS was defined from the date of CAR-T infusion to the date fo confirmed disease progression or death of any reason |
| overall survival (OS) | From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion | OS was defined from the date of CAR-T infusion to the date fo death |
Countries
China
Outcome results
None listed