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Trial Title:
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.
NCT ID:
NCT06608732
Condition:
B-cell Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Conditions: Keywords:
Inaticabtagene autoleucel
autologous hematopoietic stem cell transplantation
Minimal Residual Disease
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Inaticabtagene autoleucel
Description:
CNCT19 combined with autologous hematopoietic stem cell transplantation，Dose: （0.5 -2）x
10^6/kg CNCT19 Cell Injection via intravenous infusion.
Arm group label:
Inaticabtagene autoleucel Combined with Autologous Hematopoietic Stem Cell Transplantation
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
16 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Institute of Hematology, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300000
Country:
China
Status:
Recruiting
Contact:
Last name:
erlie EL Jiang, Doctor
Phone:
15122538106
Phone ext:
022-23608602
Email:
jiangerlie@ihcams.ac.cn
Start date:
August 1, 2024
Completion date:
July 1, 2028
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Collaborator:
Agency:
Juventas Cell Therapy Ltd.
Agency class:
Industry
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06608732
