Combining a new cell therapy with stem cell transplantation for leukemia patients in 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.
PHASE2 · Institute of Hematology & Blood Diseases Hospital, China · NCT06608732
This study is testing a new cell therapy combined with stem cell transplantation to see if it can help teenagers and adults with a type of leukemia who are in remission but still have some cancer cells left.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 16 Years to 70 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China (other) |
| Drugs / interventions | CAR-T, chemotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06608732 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Inaticabtagene autoleucel, a novel CAR-T cell therapy, in combination with autologous hematopoietic stem cell transplantation for adolescents and adults with minimal residual disease (MRD)-positive B-cell acute lymphoblastic leukemia (B-ALL) who are in initial complete remission. Participants must have recently diagnosed B-ALL and have undergone standard induction chemotherapy followed by consolidation therapy. The study aims to determine if this combination can improve treatment outcomes for patients with this aggressive form of leukemia.
Who should consider this trial
Good fit: Ideal candidates are adolescents or adults with newly diagnosed Ph-negative or Ph-positive B-ALL who have achieved initial complete remission and have detectable minimal residual disease.
Not a fit: Patients with Burkitt lymphoma, chronic myeloid leukemia in blast phase, or those who have previously received CAR-T cell therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve remission rates and long-term outcomes for patients with MRD-positive B-ALL.
How similar studies have performed: Other studies have shown promising results with CAR-T cell therapies in treating B-ALL, suggesting potential success for this novel combination approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tianjin, Tianjin Municipality
- National Institute of Hematology, Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: B-cell Acute Lymphoblastic Leukemia, Inaticabtagene autoleucel, autologous hematopoietic stem cell transplantation, Minimal Residual Disease