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

Phase 2

Recruiting

• Conditions: B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma; Diffuse Large B Cell Lymphoma
• Interventions: Drug: CD19/CD22-bispecific CAR-T cells

• Registration Number: NCT06081478
• Lead Sponsor: Beijing Tongren Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Status Verified: 2023-10
• Study First Submitted: 2023-10-07
• Study First Submitted QC: 2023-10-07
• Last Update Submitted: 2023-10-07
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19/CD22 CAR-T group	CD19/CD22-bispecific CAR-T cells	Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19-CAR-T cell was 2×10e6/kg and CD22-CAR-T cell was 1×10e6/kg. Both CAR-T cells were infused at the same day.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Liang Wang; 🇨🇳 Beijing, Beijing, China