CD20-CD19 Compound CAR (cCAR) 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 CD20-CD19 cCAR in Patients With Relapsed and/or Refractory B Cell Malignancies

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04156178

Enrollment

Registered

2019-11-07

Start date

2018-08-01

Completion date

2020-09-30

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

CD20, CD19, cCAR, Leukemia, Lymphoma

Brief summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD20-CD19 cCAR in patients with relapsed and/or refractory B cell malignancies.

Detailed description

Clinical trials with CD19-directed CARs have achieved unprecedented remission rates as high as 90%. However, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. CD20-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CD20 and CD19. CD20-CD19 cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape.

Interventions

BIOLOGICALCD20-CD19 cCAR T cells

CD20-CD19 cCAR 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. Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL 3. Patients have exhausted standard therapeutic options 4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks 5. Female must be not pregnant during the study

Exclusion criteria

1. Patients declining to consent for treatment 2. Prior solid organ transplantation 3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant 4. Prior treatment with CD20xCD3 or CD19x3 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