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

Not Applicable

• Conditions: B-ALL
• Interventions: Biological: CD19 CAR-T

• Registration Number: NCT04546893
• Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Brief 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

Detailed 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

Study Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Last Update Submitted: 2020-09-04
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1904B CAR-T	CD19 CAR-T	Patients will be treated with CD19 CAR-T cells

Primary Outcome Measures

Name	Time	Method
Safety: Incidence and severity of adverse events	First month post CAR-T cells infusion	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
Efficacy: Remission Rate	3 months post CAR-T cells infusion	Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)

Secondary Outcome Measures

Name	Time	Method
Efficacy:duration of response (DOR)	24 months post CAR-T cells infusion	duration of response (DOR)
Efficacy: progression-free survival (PFS)	24 months post CAR-T cells infusion	progression-free survival (PFS) time
CAR-T proliferation	3 months post CAR-T cells infusion	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
Cytokine release	First month post CAR-T cells infusion	Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method

Trial Locations

Locations (2)

Hebei yanda Ludaopei Hospital; 🇨🇳 Hebei, Sanhe, China

BeiJing Ludaopei Hospital; 🇨🇳 Beijing, Yizhuang, China