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

NCT06081478 | Recruiting Phase 2

• 1 other identifier: CAR-T001/TR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Best CR rate

  From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion

• Progression free survival (PFS)

  From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion

• overall survival (OS)

  From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion

Study Arms (1)

CD19/CD22 CAR-T group

EXPERIMENTAL

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.

Drug: CD19/CD22-bispecific CAR-T cells

Interventions

CD19/CD22-bispecific CAR-T cells DRUG

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

CD19/CD22 CAR-T group

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Liang Wang

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of hematology

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 13, 2023
• Study Start: January 18, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)