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To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors

Sponsor
Hebei Senlang Biotechnology Inc., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05388695
Collaborator
Tongji Hospital (Other)
100
Enrollment
1
Location
1
Arm
36.8
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).

Condition or Disease Intervention/Treatment Phase
  • Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells
 Phase 1

Detailed Description

This study is open single-arm prospective clinical study To relapse/refractory blood B cell tumor patients as the subjects, according to the expression of tumor cells, gives the corresponding double targets CART cell injection treatment, follow-up observation of the adverse reactions and the treatment effect of the drug to the data (at least 2 years), assessment of double targets CAR - T Long-term efficacy and safety of cell injection

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
To Observe the Long-term Efficacy and Safety of Dual-target Chimeric Antigen Receptor T Cells in the Treatment of Refractory Relapsed B Cell Hematologic Tumors
Actual Study Start Date :
Apr 8, 2022
Anticipated Primary Completion Date :
Mar 30, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 19+22 CART

Eligible patients will be treated with 19+22 CAR-T.

Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells
Single or sequential injection of CD19 and CD22 CAR T cells.

Outcome Measures

Primary Outcome Measures

  1. Efficacy: Remission Rate [Up to 3 months]

    Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL);

  2. CD19 positive and CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old;

4.Estimated survival time>3 months; 5.ECOG Scores: 0~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.

Exclusion Criteria:

  1. With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease;

  2. Presence of other malignant tumors;

  3. There are severe infections that cannot be effectively controlled;

  4. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood;

  5. Known positive serology for human immunodeficiency virus (HIV) or syphilis;

  6. A history of severe allergies to biological products (including antibiotics);

  7. Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD);

  8. Female patients who are under pregnancy and/or lactation;

  9. Active autoimmune disease requiring systemic immunosuppressive therapy;

  10. Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tongji Hospital Wuhan Hubei China

Sponsors and Collaborators

  • Hebei Senlang Biotechnology Inc., Ltd.
  • Tongji Hospital

Investigators

  • Principal Investigator: Liang Huang, PhD&MD, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier:
NCT05388695
Other Study ID Numbers:
  • 19+22 for B-ALL/NHL
First Posted:
May 24, 2022
Last Update Posted:
May 24, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 24, 2022