Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia

Leukemia Clinical Trial

Official title:

A Phase 1-2 Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05309213
• Other study ID #: SD3
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2022
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: Fei Wu, MD
• Phone: +8615801390058
• Email: wufei[@]immunochina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: June 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 25 Years

Eligibility

Inclusion Criteria:

• Relapsed or refractory B-ALL, defined as:

1. Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia.

2. Any relapse after HSCT and must be = 6 months from HSCT at the time of IM19 CAR-T cells infusion.

3. Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen.

• Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI ± chemotherapy ;Ph + all patients with T315I mutation are not required to receive at least two TKI ± chemotherapy in the absence of effective TKI therapy;
• Morphological evidence of disease in bone marrow (at least 5% blasts).
• Aged 3 to 25 years, either sex;
• Estimated life expectancy >3 months;
• ECOG performance status of 0 or 1(age = 16 years) or Lansky (age < 16 years) performance status = 50;
• Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up;
• Adequate organ function;
• Volunteer to participate in this trial and sign on the informed consent.

Exclusion Criteria:

• Isolated extramedullary disease relapse;
• Burkitt's lymphoma;
• Patient has obvious symptoms of central nervous system invasion and needs targeted treatment;
• Patient has previously received gene product therapy;
• Patients have graft-versus-host response(GVHD) and need to use immunosuppressants; Or GVHD = grade 2 or being treated with anti GVHD; Or suffering from autoimmune diseases;
• Patient received chemotherapy or radiotherapy within 3 days before leukapheresis
• Patient used systemic steroids within 5 days before leucapheresis, except those who were recently or currently using inhaled steroids;
• Patients who used drugs to stimulate the production of bone marrow hematopoietic cells within 5 days before leucapheresis;
• Patients have participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study;
• Patient received allogeneic cell therapy within 6 weeks before CAR-T cell infusion, such as donor lymphocyte infusion(DLI);
• History or presence of CNS disorder, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia / hemorrhage / cerebral infarction), brain edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome or mental disease;
• Patients has HBV, HCV, HIV ,EBV,ECV or syphilis infection at the time of screening;
• Pregnant or lactating, or planning pregnancy within 180 days after the end of CAR-T cells infusion, or male patients whose partners plan pregnancy 180 days after their CAR-T cell infusion;
• Patients with other tumors in the past 5 years;
• Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment.

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• IM19 CAR-T cells
IM19 CAR-T cells will be administered at dose level:5 x 10^4 CAR+ T cells/kg,1x 10^5 CAR+ T cells/kg,3 x 10^5 CAR+ T cells/kg,1 x 10^6 CAR+ T cells/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Related adverse events (AEs)		Up to 28 days after CAR-T cell infusion
Primary	Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow)	The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.	Up to 24 weeks after CAR-T cell infusion
Secondary	Objective response rate (ORR)		At 28 days, 3 months and 6 months after CAR-T cell infusion
Secondary	Anti-therapeutic IM19 CAR-T cells antibody		Up to 24 weeks after CAR-T cell infusion