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Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy

Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 Attached to TCRζ and 4-1BB Signaling Domains in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy

NCT02374333•University of Pennsylvania

View on ClinicalTrials.gov

Summary

This is a pilot study to evaluate humanized CD19 redirected autologous T cells (or huCART19 cells) in patients with relapsed or refractory CD19+ leukemia and lymphoma that was previously treated with cell therapy. This study is targeting pediatric patients aged 1-24 years with CD19+ B cell malignancies with no available curative treatment options (such as autologous or allogeneic stem cell transplantation) who have a limited prognosis with currently available therapies and were previously treated with a B cell directed engineered cell therapy product.

Eligibility

Age

1 - 24 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female subjects with documented CD19+ B cell malignancies and no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \<2 year survival) with currently available therapies will be enrolled:
•1. Eligible diseases: CD19+ leukemia or lymphoma. In general, these will be patients with:
•1. partial response or no response to prior cell therapy
•2. relapsed after prior cell therapy
•3. demonstrated B cell recovery suggesting loss of engineered cells.
•3. Documented CD19 expression (after previous B cell directed cell therapy, if applicable)
•4. Age 1 to 24 years
•5. Expected survival \> 12 weeks
•6. Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
•7. Bilirubin \<2.0 mg/dl
+7 more criteria

Exclusion Criteria

•1. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
•2. Uncontrolled active infection.
•3. Active hepatitis B or hepatitis C infection.
•4. Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
•5. Presence of grade 2-4 acute or extensive chronic GVHD.
•6. Under treatment for GVHD.
•7. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
•8. Any uncontrolled active medical disorder that would preclude participation as outlined.
•9. HIV infection

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 25, 2014

Primary Completion Date

September 2, 2021

Completion Date

September 2, 2021

Last Updated

September 23, 2021

Enrollment

ACTUAL participants

Conditions

Acute Lymphocytic LeukemiaDiffuse Large Cell Lymphoma

Interventions

huCART19

BIOLOGICAL

TCR Reserved and Power3 (SPPL3) Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-ALL

NCT06481735

Acute Lymphocytic Leukemia

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RECRUITINGPHASE1/PHASE2

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

NCT05442515

B-NHLB-Non Hodgkin Lymphoma+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy

Inclusion Criteria

Exclusion Criteria

TCR Reserved and Power3 (SPPL3) Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-ALL

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

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