Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL

NCT06641024 | Not Yet Recruiting Phase 1

• 1 other identifier: PB12
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B Cell Acute Lymphoblastic Leukemia.

Conditions

Acute Lymphoblastic Leukemia, in Relapse; Refractory Acute Lymphoblastic Leukemia

Keywords

B-ALL; CAR-T

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Dose-limiting toxicity after CD19 CAR-T cell infusion

  1 month

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute\'s Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

  1 month

Secondary Outcomes (6)

• AUCS of MC-1-50 cells [Cell dynamics]

  3 months

• CMAX of MC-1-50 cell preparation [Cell dynamics]

  3 months

• TMAX of MC-1-50 cell preparation[Cell dynamics]

  3 months

• Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]

  3 months

• Immunogenicity of pCAR-19B cells

  3 months

Other Outcomes (5)

• Objective response rate after MC-1-50 infusion [Long-term Efficacy]

  2 years

• Duration of Response (DOR) after MC-1-50 infusion [Long-term Efficacy]

  2 years

• Progress-free survival(PFS) after MC-1-50 infusion [Long-term Efficacy]

  2 years

Study Arms (1)

MC-1-50

EXPERIMENTAL

Patients will be be treated with CD19 CAR- T cells

Biological: MC-1-50

Interventions

MC-1-50 BIOLOGICAL

A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy

MC-1-50

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
• Age ≥ 18 years old (including threshold), gender not limited;
• Diagnosed with B-cell acute lymphoblastic leukemia and meeting one of the following conditions:
• Refractory B-ALL: Early refractory patients who have not achieved complete remission of bone marrow after two courses of first-line systemic therapy upon initial diagnosis;
• Relapsed B-ALL:
• ① Early relapsed after complete remission (\< 12 months);
• ② Late relapsed after complete remission (≥ 12 months) requires systemic therapy again, but if complete remission is not achieved or early treatment response is poor;
• ③ Having experienced 2 or more times bone marrow relapse;
• ④ Relapsed after allogeneic hematopoietic stem cell transplantation;
• Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they have relapsed/refractory disease despite treatment with at least 2 different tyrosine kinase inhibitors (TKIs); (Note: Except for those who are intolerant to TKI therapy, or have T315i mutations);
• Flow cytometry confirms the expression of CD19 in leukemia cells in the bone marrow. In individuals previously treated with targeted CD19 antibodies (such as blinatumomab), the proportion of CD19 positive cells in leukemia cells must be ≥ 90%;
• Morphological disease in the bone marrow (≥ 5% blasts);
• ECOG score 0-1;
• Expected survival time of more than 12 weeks;
• Adequate renal, hepatic, pulmonary and cardiac function defined as:

You may not qualify if:

• Isolated extramedullary disease;
• Central nervous system abnormalities: defined as CNS-2 and 3 according to NCCN guidelines (note: CNS-2 and 3 can be screened, but must be treated and recovered to CNS-1 before lymphodepleting chemotherapy and infusion);
• Transformation of chronic myeloid leukemia to acute biphenotypic leukemia;
• Individuals who have received CAR-T therapy or other gene modified cell therapies;
• Prior to apheresis, the following anti-tumor treatments have been received: chemotherapy, targeted therapy, and other drug treatments within 14 days or at least 5 half lives (whichever is shorter); Received radiation therapy within 14 days;
• HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive;HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive;
• Suffered from any of the following heart diseases:
• New York Heart Association (NYHA) stage III or IV congestive heart failure;
• Within the 6 months prior to enrollment, there has been a myocardial infarction, or a coronary artery bypass grafting (CABG) or stent implantation surgery has been performed;
• History of ventricular arrhythmias requiring treatment or unexplained syncope (excluding cases caused by vasovagal or dehydration);
• History of severe non-ischemic cardiomyopathy;
• Uncontrollable infection in the 2 weeks before enrollment;
• Acute grade 2-4 graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within the first 4 weeks of enrollment;
• If a cerebrovascular accident or seizure occurs within the first 6 months of enrollment;
• Active autoimmune diseases;

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead
• Ruijin Hospital: collaborator

Study Sites (1)

Rui Jin hospital, Shanghai Jiao Tong university school of medicine

Shanghai, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jian qing Mi, M.D.

CONTACT

+8613524488296; jianqingmi@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2039
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)