CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies

Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD19 CARvac in Patients With Relapsed and/or Refractory B Cell Malignancies

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04156243

Enrollment

Registered

2019-11-07

Start date

2018-02-01

Completion date

2020-02-28

Last updated

2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B Cell Leukemia, B Cell Lymphoma

Keywords

CD19, CD19 CAR T cell

Brief summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.

Detailed description

CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat

Interventions

BIOLOGICALCD19 CARvac T cells

CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Diagnosis based on the World Health Organization (WHO) 2008 2. Patients have exhausted standard therapeutic options 3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks 4. Female must be not pregnant during the study

Exclusion criteria

1. Prior solid organ transplantation 2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant 3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents

Design outcomes

Primary

Measure	Time frame
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	28 days
Type of dose-limiting toxicity (DLT)	28 days
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	2 years

Secondary

Measure	Time frame	Description
Overall Response Rate (ORR)	1 year	Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Progression-free survival (PFS)	1 year	—
Overall survival	1 year	—

Countries

China

Contacts

Primary ContactKevin Pinz

kevin.pinz@icellgene.com6315386218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026