Clinical trial NCT04156178: CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: B Cell Lymphoma
B Cell Leukemia
Keywords: CD20
CD19
cCAR
Leukemia
Lymphoma
Lead sponsor: iCell Gene Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Peking University Shenzhen Hospital
name: Chengdu Military General Hospital
name: iCAR Bio Therapeutics Ltd.
First posted: 2019-11-07
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 28 days
measure: Type of dose-limiting toxicity (DLT)
timeFrame: 28 days
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 year
measure: Progression-free survival (PFS)
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Military General Hospital
city: Shanghai
country: China
facility: Peking University Shenzhen Hospital
Study officials:
affiliation: Peking University Shenzhen Hospital
name: Hongyu Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chengdu Military General Hospital
name: Fang Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: