Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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。
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteers | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CAR-T | Drug | CD19 CAR-T infusion for patients with CD19 positive tumor cells |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiang Li, PhD&MD | Contact | +8631189928689 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Luo, PhD&MD | The Second Hospital of Hebei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.2 Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C024352 | fludarabine |
| C000707715 | fiu protein, E coli |
| D003520 | Cyclophosphamide |
| D053493 | Cholestanetriol 26-Monooxygenase |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CD22 CAR-T | Drug | CD22 CAR-T infusion for patients with CD22 positive tumor cells |
|
|
| CD19+CD22 CAR-T | Drug | CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells |
|
|
| Fludarabine | Drug | 25mg/㎡ for D-4、D-3 and D-2 |
|
|
| Cyclophosphamide | Drug | 500mg/㎡ for D-3 and D-2 |
|
|
| 24 months |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000072501 | Cytochrome P450 Family 27 |
| D003577 | Cytochrome P-450 Enzyme System |
| D003580 | Cytochromes |
| D045762 | Enzymes and Coenzymes |
| D013250 | Steroid Hydroxylases |
| D006899 | Mixed Function Oxygenases |
| D010105 | Oxygenases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D006420 | Hemeproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |