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Phase I Trial for High-Risk Blood Cancers Using CAR-T Cells and Transplant

This study is for people aged 18 to 75 with high-risk blood cancers (hematologic malignancies) that are CD19-positive. It is testing a new way to treat these cancers by combining two powerful therapies: a bone marrow transplant (HLA-haploidentical hematopoietic cell transplantation, or HCT) and CAR-T cell therapy. CAR-T cell therapy uses your own immune cells, called T-cells, which are specially modified in the lab to find and destroy cancer cells. In this study, you would receive these modified CAR-T cells (mCD19-CAR-CD28-CD3-zeta) along with standard transplant medications like Fludarabine, Cyclophosphamide, Mycophenolate Mofetil, and Sirolimus. The main goals are to see how safe this combined treatment is and to understand its effects on relapse and survival after one year. The study is currently recruiting 155 participants, but its status is unclear.

Study design
This is an interventional Phase I study, meaning it's an early-stage trial focused on safety. It plans to enroll 155 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track your relapse and survival outcomes for at least one year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07162038

Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation

Recruiting
PHASE1Ages 18–75InterventionalTreatment
National Cancer Institute (NCI)
~155 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:mCD19-CAR-CD28-CD3-zeta.(anti-CD19 CAR) retroviral vector-transduced allogeneic peripheral blood lymphocytes (PBL)FludarabineCyclophosphamideMycophenolate MofetilSirolimusCD19 Flow Cytometry Assay

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identify the safety of anti-CD19 CAR T-cell therapy in combination with HLA-haploidentical HCT in participants with high risk CD19+ hematologic malignancies
Measured over 28 days (or 35 days for alternate dose levels)
+1 more outcome measured

Conditions

Hematologic Malignancies
Hematologic Neoplasms

Explore related trials

Hematologic NeoplasmCD19 Gene

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Christopher G Kanakry, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Amy H Chai
[email protected]
(240) 858-3755
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Cardiac ejection fraction \>= 45% by 2D echocardiography;
Forced expiratory volume-1 (FEV-1) and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \>=50% predicted (this requirement would be waived in participants who are unable to properly perform pulmonary function tests - in such circumstances, participants must have pulse oximetry \>=90% on room air and no dyspnea or obvious pulmonary restrictions);
Estimated serum creatinine clearance of \>= 60 ml/minute/1.73m\^2 calculated using eGFR in the clinical lab (participants with estimated serum creatinine clearance less than 60 may have measured creatinine clearance performed and if \>= 60 will be considered eligible);
Total bilirubin \<= 2X the upper limit of normal (participants with documented or suspected Gilbert s are exempt from this requirement);
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 5X the upper limit of normal. 6. At least one available HLA-haploidentical donor 7. Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) at the study entry and for 1 year after transplant (restriction period).

What this trial measures

  • Identify the safety of anti-CD19 CAR T-cell therapy in combination with HLA-haploidentical HCT in participants with high risk CD19+ hematologic malignancies28 days (or 35 days for alternate dose levels)

    Determine the fraction of evaluable recipient participants at each dose level who experience a dose-limiting toxicity (DLT).

  • Estimate the 1 year relapse and survival outcomes at the maximum tolerated dose1 year

    Estimates will be determined using Kaplan-Meier curves or competing risk-based cumulative incidence curves as appropriate for participants treated at the MTD and may be reported individually for the MTD and other dose levels. The results at indicated time points will be reported and may include 95% confidence intervals as appropriate.