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.

NCT06608732 | Recruiting Phase 2

• 1 other identifier: IIT2024037
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Acute Lymphoblastic Leukemia

Keywords

Inaticabtagene autoleucel; autologous hematopoietic stem cell transplantation; Minimal Residual Disease

Outcome Measures

Primary Outcomes (1)

• Relapse-Free Survival

  The time from the start of infusion of Inaticabtagene autoleucel until the diagnosis of relapse or any death (whichever comes first).

  From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Secondary Outcomes (3)

• 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

• MRD negativity rate

  28 days after the first CAR-T cell reinfusion

Study Arms (1)

Inaticabtagene autoleucel Combined with Autologous Hematopoietic Stem Cell Transplantation

EXPERIMENTAL

Biological: Inaticabtagene autoleucel

Interventions

Inaticabtagene autoleucel BIOLOGICAL

CNCT19 combined with autologous hematopoietic stem cell transplantation，Dose: （0.5 -2）x 10\^6/kg CNCT19 Cell Injection via intravenous infusion.

Inaticabtagene autoleucel Combined with Autologous Hematopoietic Stem Cell Transplantation

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Juventas Cell Therapy Ltd.: collaborator

Study Sites (1)

National Institute of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 23, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)