Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 65

Combining stem cell transplantation with CD19-CART for treating high-risk leukemia in adults

Official title: Clinical Study of Autologous Hematopoietic Stem Cell Transplantation Combined With CD19-CART Treatment for Adult High-risk Acute Lymphoblastic Leukemia

Run by Institute of Hematology & Blood Diseases Hospital, China · NCT06608342 · Data updated 2026-11-12

This study is testing a new treatment that combines stem cell transplant with a special type of immune therapy to see if it helps adults with high-risk leukemia feel better and stay in remission.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment20 (estimated)
SponsorInstitute of Hematology & Blood Diseases Hospital, China
Academic / other
Drugs / interventionsCAR-T, chemotherapy, CART
Locations1 site (Tianjin, Tianjin Municipality)
StatusRecruiting
StartedJune 25, 2024
Main results expectedMay 30, 2026
Study endsMay 30, 2028
Registry record updatedSeptember 23, 2024
Trial IDNCT06608342 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with high-risk acute B-lymphoblastic leukemia who have achieved complete remission and are eligible for stem cell transplantation.

Probably not a fit

Patients with other malignant tumors, uncontrolled serious infections, or significant organ dysfunction may not benefit from this study.

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 effectiveness and safety of autologous hematopoietic stem cell transplantation combined with CD19-CART therapy in adults diagnosed with high-risk acute lymphoblastic leukemia (ALL). Participants who have achieved complete remission after induction chemotherapy and have successfully prepared autologous CD19-CAR-T will receive this combined treatment. The study aims to observe both the efficacy and potential side effects of this innovative approach in managing ALL.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for adults with high-risk acute lymphoblastic leukemia.

How similar studies have gone: Other studies have shown promise with similar approaches, indicating potential for success in this novel treatment strategy.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patients with high-risk acute B-lymphoblastic leukemia
* Complete remission was achieved after induction chemotherapy, and autologous CD19-CAR-T was successfully prepared
* Eligible for autologous hematopoietic stem cell transplantation
* No major organ dysfunction

Exclusion Criteria:

* Combined with malignant tumors of other organs
* With a serious infection that is not under control
* Syphilis, AIDS, hepatitis B, hepatitis C, any one of them positive
* Patients who have had an allergic reaction to the drugs used in this study or similar drugs
* Other patients deemed unsuitable for inclusion by the investigators

Where it's running

  • NO.288 Nanjing Road,Heping District,Tianjin, Tianjin,
    Tianjin, Tianjin Municipality, China
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.