Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    04626726
Previous Study | Return to List | Next Study

Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04626726
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary:
This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

Condition or disease Intervention/treatment Phase
Adult B Acute Lymphoblastic Leukemia Drug: CD19 CAR-T Drug: CD22 CAR-T Drug: CD19+CD22 CAR-T Drug: Fludarabine Drug: Cyclophosphamide Early Phase 1

Detailed Description:
This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023


Arm Intervention/treatment
Experimental: Volunteers
The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia expressing specific target antigens
Drug: CD19 CAR-T
CD19 CAR-T infusion for patients with CD19 positive tumor cells
Other Name: Senl_19

Drug: CD22 CAR-T
CD22 CAR-T infusion for patients with CD22 positive tumor cells
Other Name: Senl_22

Drug: CD19+CD22 CAR-T
CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
Other Name: Senl_19+22

Drug: Fludarabine
25mg/㎡ for D-4、D-3 and D-2
Other Name: fiu

Drug: Cyclophosphamide
500mg/㎡ for D-3 and D-2
Other Name: ctx




Primary Outcome Measures :
  1. Number of Participants with Severe/Adverse Events as a Measure of Safety [ Time Frame: 28 days ]
    Number of Participants with Severe/Adverse Events as a Measure of Safety

  2. Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) [ Time Frame: 24 months ]
    Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)


Secondary Outcome Measures :
  1. Objective response rate of complete remission and partial remission [ Time Frame: 24 months ]
    Objective response rate of complete remission and partial remission

  2. Overall survival time [ Time Frame: 24 months ]
    Overall survival time



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
  2. ECOG score≤2;
  3. To be aged 1 to 65 years;
  4. More than a month lifetime from the consent signing date.

Exclusion Criteria:

  1. Serious cardiac insufficiency, left ventricular ejection fraction<50%;
  2. Has a history of severe pulmonary function damaging;
  3. Merging other progressing malignant tumor;
  4. Merging uncontrolled infection;
  5. Merging the metabolic diseases (except diabetes);
  6. Merging severe autoimmune diseases or immunodeficiency disease;
  7. Patients with active hepatitis B or hepatitis C;
  8. Patients with HIV infection;
  9. Has a history of serious allergies on Biological products (including antibiotics);
  10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
  11. Pregnancy or lactation women;
  12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626726


Contacts
Layout table for location contacts
Contact: Jianqiang Li, PhD&MD +8631189928689 limmune@gmail.com

Locations
Layout table for location information
China, Hebei
No.2 Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Jianqiang Li, PhD & MD    +86311-89928689    limmune@gmail.com   
Contact: Jianmin Luo, PhD & MD    +86311-66002304      
Principal Investigator: Jianmin Luo, PhD & MD         
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Jianmin Luo, PhD&MD The Second Hospital of Hebei Medical University
Layout table for additonal information
Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04626726    
Other Study ID Numbers: CAR-T for adult B-ALL
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists