Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia

B-ALL Clinical Trial

Official title:

Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04546893
• Other study ID #: 1904B for B-ALL
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2020
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Peihua Lu, PhD&MD
• Phone: 008618611636172
• Email: peihua_lu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL

Description:

The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of 1904B in patients with recurrent or refractory B-ALL

The Secondary research objectives:

To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;

2. A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;

3. ECOG Scores: 0~2

4. CD19 positivewere detected by immunohistochemistry or flow cytometry;

5. Estimated survival time>3 months;

6. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

Exclusion Criteria:

1. Serious cardiac insufficiency;

2. Has a history of severe pulmonary function damaging;

3. With other tumors which is/are in advanced malignant and has/have systemic metastasis;

4. Severe or persistent infection that cannot be effectively controlled;

5. Merging severe autoimmune diseases or immunodeficiency disease;

6. Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);

7. Patients with HIV infection or syphilis infection;

8. Has a history of serious allergies on Biological products (including antibiotics);

9. Being pregnant and lactating or having pregnancy within 12 months;

10. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Related Conditions & MeSH terms

• B-ALL
• Leukemia

Intervention

Biological:
• CD19 CAR-T
Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

Locations

Country	Name	City	State
China	BeiJing Ludaopei Hospital	Beijing	Yizhuang
China	Hebei yanda Ludaopei Hospital	Hebei	Sanhe

Sponsors (3)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.	Beijing Ludaopei Hospital, Hebei Yanda Ludaopei Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence and severity of adverse events	To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity	First month post CAR-T cells infusion
Primary	Efficacy: Remission Rate	Remission Rate including complete remission(CR)?CR with incomplete blood count recovery(CRi)?No remission(NR)	3 months post CAR-T cells infusion
Secondary	Efficacy:duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Secondary	Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion
Secondary	CAR-T proliferation	the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method	3 months post CAR-T cells infusion
Secondary	Cytokine release	Cytokine( IL-6,IL-10,IFN-?,TNF-a ) concentration (pg/mL) by flow cytometry method	First month post CAR-T cells infusion