Combining a new cell therapy with stem cell transplantation for leukemia patients in remission

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Institute of Hematology, Chinese Academy of Medical Sciences
  Tianjin, Tianjin Municipality, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.