Clinical trial · Interventional

Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia

Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Leukemia

NCT04100187CI-TRIAL-00062441unknownPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Anti-CD19-CAR	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
experimental:3
description
Leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
interventionNames
1. Biological: Anti-CD19-CAR

Primary outcomes (4)

measure
Adverse events of each patient
timeFrame
3 years
description
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
measure
Survival time of Anti-CD19 CAR T cells in vivo
timeFrame
3 years
description
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 2 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

1. Relapsed or refractory B cell Leukemia.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 2 years to 70 years.
5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial

Exclusion Criteria:

1. KPS\<50.
2. Patients are allergic to cytokines.
3. Uncontrolled active infection.
4. Acute or chronic GVHD.
5. Treated with T cell inhibitor.
6. Pregnancy and nursing females.
7. HIV/HBV/HCV Infection.
8. Other situations we think improper for the research.

References

Publications (0)

Data not yet available

No reference posted for this study.