NCT04825496

Brief Summary

This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of ssCART-19 in the treatment of patients with CD19 positive relapsed or refractory acute lymphoblastic leukemia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

April 9, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 21, 2023

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

March 28, 2021

Last Update Submit

September 17, 2023

Conditions

Relapsed or Refractory Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Dose Limiting Toxicity (DLT)

    Determine the safety and tolerability of ssCART-19 in patients with refractory or relapsed acute lymphoblastic leukemia. Safety measures include adverse events as assessed by CTCAE v5.0.

    28 days

Secondary Outcomes (4)

  • Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi)

    3 months

  • Duration of remission (DOR)

    24 months

  • Progression-free Survival (PFS)

    24 months

  • Overall survival (OS)

    24 months

Other Outcomes (2)

  • cellular pharmacokinetic (PK) profile of ssCART-19 cells

    24 months

  • Anti-drug antibody

    24 months

Study Arms (1)

ssCART-19 Cells

EXPERIMENTAL

Route of administration: Intravenous injection. Lymphodepletion conditioning: Lymphodepletion will be conducted several days prior to ssCART-19 cells infusion. A combination of fludarabine and cyclophosphamide will be used for lymphodepletion.

Genetic: ssCART-19 CellsDrug: FludarabineDrug: Cyclophosphamide

Interventions

ssCART-19 CellsGENETIC

Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.

ssCART-19 Cells
FludarabineDRUG

Fludarabine is used for lymphodepletion.

Also known as: FA
ssCART-19 Cells
CyclophosphamideDRUG

Cyclophosphamide is used for lymphodepletion.

Also known as: CTX
ssCART-19 Cells

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed or refractory acute lymphoblastic leukemia (ALL):(1)Any Relaps after first remission OR (2)Any BM relapse after allogeneic SCT and must be ≥ 3 months from SCT at the time of ssCART-19 infusion OR (3)failed to reach CR after 2 cycles of induction chemotherapy regimen OR (4)Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI therapy, or if TKI therapy is contraindicated
  • CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry
  • Bone marrow with ≥ 5% lymphoblasts by morphologic assessment
  • Adequate organ function defined as:(1)left ventricular ejection fraction ≥ 50% by echocardiogram；(2)creatinine ≤ 1.6mg/dl；(3)ALT and AST≤3 times the ULN for age, total bilirubin ≤ 2.0mg/dl；(4)Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation \> 91% on room air
  • Informed consent is signed by the subject
  • Age 18 to 65
  • Fertility of men, to ensure that sexual partners can effectively contraception; Women with fertility use effective contraceptive measures and agree to use contraceptive measures throughout the study period
  • Qualified T cell amplification
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • Vascular conditions for apheresis
  • The estimated survival time is more than 3 months

You may not qualify if:

  • Isolated extra-medullary disease relapse
  • Combined with other malignant tumors
  • Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other antiCD19 therapy
  • Has had immunosuppressants or hormones within 2 weeks before signing informed consent, or plan to use immunosuppressants or hormones after signing informed consent
  • Patients complying with any of hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive, hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab) positive and HBV-DNA copies being more than the lower limit of detection, hepatitis C antibody (HCV-Ab) positive, anti-treponemia pallidum antibody (TP-Ab) positive, EBV-DNA, and CMV-DNA copies being more than the lower limit of detection
  • Has uncontrolled bacteria, fungi, viruses, mycoplasma or other types of infections
  • Infected with HIV, syphilis or COVID-19
  • Has a history of severe immediate hypersensitivity to aminoglycosides
  • Has past or present CNS diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases or any CNS-related autoimmune diseases
  • Has undergone cardiac angioplasty or stent implantation within 12 months before signing informed consent, or having a history of myocardial infarction, unstable angina pectoris or other clinically significant heart diseases
  • With primary immunodeficiency
  • Has had severe immediate hypersensitivity reaction to any drug to be used in this study
  • Has had treat with live vaccine within 6 weeks prior to screening
  • Pregnant or lactating women
  • Has active autoimmune diseases
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.

Shanghai, Shanghai Municipality, 201210, China

RECRUITING

MeSH Terms

Conditions

RecurrencePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

fludarabineCyclophosphamide

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Central Study Contacts

Xiaoyan Lou, Dr.

CONTACT

18721281671xiaoyan.lou@unicar-therapy.com

Liqing Kang, Dr.

CONTACT

13162512992liqing.kang@unicar-therapy.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2021

First Posted

April 1, 2021

Study Start

April 9, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

September 21, 2023

Record last verified: 2023-05

Locations

CN(1)