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

Hebei Senlang Biotechnology

Status and phase: Unknown; Early Phase 1

Conditions: Adult B Acute Lymphoblastic Leukemia

Treatments: Drug: CD19+CD22 CAR-T; Drug: CD19 CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: CD22 CAR-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT04626726

CAR-T for adult B-ALL

Details and patient eligibility

About

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.

Full 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。

Enrollment: 50 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Volunteers

Experimental group

Description:

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

Treatment:

Drug: CD22 CAR-T

Drug: Cyclophosphamide

Drug: Fludarabine

Drug: CD19 CAR-T

Drug: CD19+CD22 CAR-T