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

NCT ID: NCT06081478

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2026-12-31

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.

Conditions

B-cell Acute Lymphoblastic Leukemia; B-cell Lymphoma; Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CD19/CD22 CAR-T group

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.

Group Type: EXPERIMENTAL

CD19/CD22-bispecific CAR-T cells

Intervention Type: DRUG

CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

LIANG WANG

Director of the department of hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Liang Wang

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Liang Wang, M.D.

Role: primary

wangliangtrhos@126.com

+8615001108693

Other Identifiers

CAR-T001/TR

Identifier Type: -

Identifier Source: org_study_id