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

Adult B Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626726
• Other study ID #: CAR-T for adult B-ALL
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: November 2020
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Jianqiang Li, PhD&MD
• Phone: +8631189928689
• Email: limmune[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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。

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adult B Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• CD19 CAR-T
CD19 CAR-T infusion for patients with CD19 positive tumor cells
• CD22 CAR-T
CD22 CAR-T infusion for patients with CD22 positive tumor cells
• CD19+CD22 CAR-T
CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
• Fludarabine
25mg/? for D-4?D-3 and D-2
• Cyclophosphamide
500mg/? for D-3 and D-2

Locations

Country	Name	City	State
China	No.2 Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Objective response rate of complete remission and partial remission	Objective response rate of complete remission and partial remission	24 months
Secondary	Overall survival time	Overall survival time	24 months