Tests CD19/CD22 bispecific CAR-T cells in relapsed B-cell lymphoma or leukemia
Tests modified immune cells against two targets in people with returning B-cell blood cancers.
Plain-language title generated from the registry record
Registry title: CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 85 years old?
Source: NCT06081478, who can take part
Where in China
- Liang WangBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing Tongren Hospital
- Trial code
- NCT06081478
- Record updated
- 13 October 2023
- Original description
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.Read full original descriptionShow less
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia: a Prospective, Single-arm, Single-center, Phase 2 Clinical Trial
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.
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: previously treatment with any gene therapy products; Uncontrolled active infection, HIV infection, syphilis serology reaction positive; Active hepatitis B or hepatitis C infection; With severe cardiac, liver, renal insufficiency, diabetes and other diseases; Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test); Recent or current use of glucocorticoid or other immunosuppressor; Participate in other clinical research in the past three months; Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.