CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia

Diffuse Large B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081478
• Other study ID #: CAR-T001/TR
• Status: Recruiting
• Phase: Phase 2
• Start date: January 18, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• B-cell Lymphoma
• Diffuse Large B Cell Lymphoma
• Leukemia
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• CD19/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.

Locations

Country	Name	City	State
China	Liang Wang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best ORR	Overall response rate means sum of complete response rate and partial response rate	From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Secondary	Best CR rate	CR was defined as complete remission evaluated using PET-CT scan or BM test	From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Secondary	Progression free survival (PFS)	PFS was defined from the date of CAR-T infusion to the date fo confirmed disease progression or death of any reason	From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
Secondary	overall survival (OS)	OS was defined from the date of CAR-T infusion to the date fo death	From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion