B-cell Acute Lymphoblastic LeukemiaPhase 2NCT06608732

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.

A Phase 2 study testing Inaticabtagene autoleucel in people with B-cell Acute Lymphoblastic Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 to 70 years
Conditions the study is for: B-cell Acute Lymphoblastic Leukemia
What is being tested?: Inaticabtagene autoleucel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 1 Aug 2024to 1 Jul 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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 \&gt; 0% detected by routine q-PCR technology.
No significant organ dysfunction
Willing and meet the conditions for autologous hematopoietic stem cell transplantation

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

National Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300000
erlie EL Jiang, Doctor, 15122538106 ext. 022-23608602, jiangerlie@ihcams.ac.cn
Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

Conditions: B-cell Acute Lymphoblastic Leukemia
Being tested: Inaticabtagene autoleucel
Keywords: Inaticabtagene autoleucel, autologous hematopoietic stem cell transplantation, Minimal Residual Disease
Medical subject headings: Burkitt Lymphoma, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06608732
Study group	Role	What they receive
Inaticabtagene autoleucel Combined with Autologous Hematopoietic Stem Cell Transplantation	Experimental	Not described Receives: Biological: Inaticabtagene autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

Relapse-Free Survival
The time from the start of infusion of Inaticabtagene autoleucel until the diagnosis of relapse or any death (whichever comes first).
Measured: From autologous hematopoietic stem cell transplantation to 2 years after transplantation

Secondary outcomes (3)

Overall survival rate
Measured: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Cumulative recurrence rate
Measured: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
MRD negativity rate
Measured: 28 days after the first CAR-T cell reinfusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20241 Jul 2028

First posted23 Sep 2024
Study start1 Aug 2024
Primary completion1 Jul 2028 (estimated)
Study completion1 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06608732
Sponsor's protocol ID: IIT2024037
Status last verified: Nov 2024
First submitted: 10 Sep 2024
Last updated: 5 Nov 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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