Status:
RECRUITING
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.
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Juventas Cell Therapy Ltd.
Conditions:
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06608732
Start Date
August 1 2024
End Date
July 1 2028
Last Update
November 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300000