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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CD19/CD22-bispecific CAR-T cells
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

14 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liang WangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD19/CD22 CAR-T group

Arm Description

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.

Outcomes

Primary Outcome Measures

Best ORR
Overall response rate means sum of complete response rate and partial response rate

Secondary Outcome Measures

Best CR rate
CR was defined as complete remission evaluated using PET-CT scan or BM test
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
overall survival (OS)
OS was defined from the date of CAR-T infusion to the date fo death

Full Information

First Posted
October 7, 2023
Last Updated
October 7, 2023
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06081478
Brief Title
CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma or Acute Lymphoblastic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma, Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD19/CD22 CAR-T group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CD19/CD22-bispecific CAR-T cells
Intervention Description
CD19/CD22-bispecific CAR-T cells were infused at the same day with 2×10e6/kg and 1×10e6/kg dosage, respectively.
Primary Outcome Measure Information:
Title
Best ORR
Description
Overall response rate means sum of complete response rate and partial response rate
Time Frame
From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Secondary Outcome Measure Information:
Title
Best CR rate
Description
CR was defined as complete remission evaluated using PET-CT scan or BM test
Time Frame
From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
Title
Progression free survival (PFS)
Description
PFS was defined from the date of CAR-T infusion to the date fo confirmed disease progression or death of any reason
Time Frame
From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion
Title
overall survival (OS)
Description
OS was defined from the date of CAR-T infusion to the date fo death
Time Frame
From the day of CAR-T cells infusion to 12 months post-CAR-T cells infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Liang Wang
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang, M.D.
Phone
+8615001108693
Email
wangliangtrhos@126.com
First Name & Middle Initial & Last Name & Degree
Liang Wang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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