Inaticabtagene Autoleucel for B-ALL Patients

Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1

Recruiting Phase 2 Interventional Study
Acute Lymphoblastic Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
16 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Ruijin Hospital · Other
Who this trial is looking for

This trial is looking for adults with a type of blood cancer called B-ALL who are in their first complete remission but still have some remaining cancer cells. Taking part involves undergoing a special blood collection process, receiving treatment that helps clear your existing blood cells, and then getting an infusion of a new type of therapy called CAR-T cells.

Are You a Good Fit for This Trial?
Rules you out Inherited bone marrow failure syndromeActive systemic autoimmune diseaseCongestive heart failureActive infection

You may be able to join if

  • I am between 16 and 70 years old.
  • I have been diagnosed with Ph-negative or Ph-positive B-ALL.
  • I am in my first complete remission but still have some cancer cells.
  • I have enough healthy organs to participate.
  • I have signed the informed consent form.

You may not be able to join if

  • I have received CAR-T cell therapy before.
  • I have a history of active autoimmune disease.
  • I have a recent heart condition or severe arrhythmia.
  • I have active infections right now.
  • I have a serious history of deep vein thrombosis or pulmonary embolism in the past six months.
  • I have uncontrolled diabetes.
  • I have participated in another clinical trial recently.
  • I have had a live vaccine in the past six weeks.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This investigator-initiated, prospective, single-arm, open-label, single-center clinical study aims to evaluate the efficacy and safety of Inaticabtagene autoleucel (Inati-cel;CNCT19)CD19 CAR-T theraphy in adults B-ALL that are in first complete remission(CR1) with minimal residual disease (MRD) positivity. This trial will enroll 20 participants for leukapheresis and treatment with lymphodepleting…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age between ≥16 and ≤70 years at screening, no gender restrictions * ECOG score of 0-1 at screening * Newly diagnosed Ph-negative B-ALL, MRD positive(bone marrow MRD ≥0.01% by flow cytometry) in CR1 (with \<5% blasts in bone marrow, no blasts in peripheral blood, no extramedul…
Contacts

Jiayi Ren, MD

+86 13651996101

renjiayi94@163.com

CONTACT