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

Study Overview
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Brief Summary
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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.

Detailed Description
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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。

Official Title
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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

Conditions
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Adult B Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: CD19 CAR-T
* Drug: CD22 CAR-T
* Drug: CD19+CD22 CAR-T
* Drug: Fludarabine
* Drug: Cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies: ECOG score≤2; To be aged 1 to 65 years; More than a month lifetime from the consent signing date. Exclusion Criteria: Serious cardiac insufficiency, left ventricular ejection fraction<50%; Has a history of severe pulmonary function damaging; Merging other progressing malignant tumor; Merging uncontrolled infection; Merging the metabolic diseases (except diabetes); Merging severe autoimmune diseases or immunodeficiency disease; Patients with active hepatitis B or hepatitis C; Patients with HIV infection; Has a history of serious allergies on Biological products (including antibiotics); Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month; Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volunteers<br>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<br>* CD19 CAR-T infusion for patients with CD19 positive tumor cells<br>* Other names: Senl_19;Drug: CD22 CAR-T<br>* CD22 CAR-T infusion for patients with CD22 positive tumor cells<br>* Other names: Senl_22;Drug: CD19+CD22 CAR-T<br>* CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells<br>* Other names: Senl_19+22;Drug: Fludarabine<br>* 25mg/㎡ for D-4、D-3 and D-2<br>* Other names: fiu;Drug: Cyclophosphamide<br>* 500mg/㎡ for D-3 and D-2<br>* Other names: ctx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Severe/Adverse Events as a Measure of Safety | Number of Participants with Severe/Adverse Events as a Measure of Safety | 28 days | 
| Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) | Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate of complete remission and partial remission | Objective response rate of complete remission and partial remission | 24 months | 
| Overall survival time | Overall survival time | 24 months |