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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06081478
Other study ID # CAR-T001/TR
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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