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.

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06608732

Enrollment

Registered

2024-09-23

Start date

2024-08-01

Completion date

2028-07-01

Last updated

2024-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Acute Lymphoblastic Leukemia

Keywords

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

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

Interventions

BIOLOGICALInaticabtagene autoleucel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026