Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.

Phase 2

Recruiting

• Conditions: B-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: Inaticabtagene autoleucel

• Registration Number: NCT06608732
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.

Detailed Description

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

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

Inclusion Criteria

• ECOG score of 0 to 1
• Newly diagnosed Ph-negative B-ALL within 6 months, achieving CR1 after standard induction chemotherapy, undergoing at least one consolidation therapy, and patients with bone marrow MRD ≥ 0.01% detected by routine flow cytometry.
• Or newly diagnosed Ph-positive B-ALL within 6 months, achieving CR1 after guideline-recommended induction chemotherapy (or use of TKI), undergoing at least one consolidation therapy, and patients with BCR-ABL1 > 0% detected by routine q-PCR technology.
• No significant organ dysfunction
• Willing and meet the conditions for autologous hematopoietic stem cell transplantation

Exclusion Criteria

• Burkitt lymphoma/leukemia, heterozygous or double-expressor leukemia, or chronic myeloid leukemia in blast phase.
• Before screening or pre-treatment, bone marrow or peripheral blood with blasts ≥ 5%; or extramedullary leukemia.
• Individuals who have received CAR-T cell therapy before screening or pre-treatment; or patients who have undergone hematopoietic stem cell transplantation.
• Patients with associated genetic syndromes related to bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inaticabtagene autoleucel Combined with Autologous Hematopoietic Stem Cell Transplantation	Inaticabtagene autoleucel	-

Primary Outcome Measures

Name	Time	Method
Relapse-Free Survival	From autologous hematopoietic stem cell transplantation to 2 years after transplantation	The time from the start of infusion of Inaticabtagene autoleucel until the diagnosis of relapse or any death (whichever comes first).

Secondary Outcome Measures

Name	Time	Method
MRD negativity rate	28 days after the first CAR-T cell reinfusion
Overall survival rate	From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Cumulative recurrence rate	From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Trial Locations

Locations (1)

National Institute of Hematology, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin, China