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A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

T

Tongji University

Status and phase

Completed
Phase 1

Conditions

B Cell Lymphoma

Treatments

Biological: CD20-directed CAR-T cells with CliniMACS Prodigy® system

Study type

Interventional

Funder types

Other

Identifiers

NCT04036019
0504-009

Details and patient eligibility

About

This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.

Full description

This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.

Enrollment

13 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. The patient volunteered to participate in the study, and signed the Informed Consent
  2. Age 18-70 years old, male or female
  3. Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
  4. r/r lymphoma patients who received prior CD19 CAR-T therapy
  5. At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
  6. No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
  7. No mAb treatment within 2 weeks before C-CAR066 infusion
  8. Adequate organ and bone marrow function
  9. No contraindications of apheresis
  10. Expected survival time > 3 months
  11. ECOG scores 0-1

Exclusion criteria

  1. Have a history of allergy to cellular products

  2. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard

  3. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease

  4. Patients with active CNS involvement

  5. Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor

  6. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed

  7. Live vaccination within 4 weeks before apheresis

  8. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers

  9. Have a history of alcoholism, drug addiction and mental illness

  10. Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception

  11. Patients with severe fludarabine or cyclophosphamide hypersensitivity

  12. The patient has a history of other primary cancers, except for the following:

    1. Non-melanoma such as skin basal cell carcinoma cured by resection
    2. Cured carcinoma in situ such as cervical, bladder or breast cancer
  13. The investigators believe that there are other circumstances that are not suitable for the trial

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

C-CAR066
Experimental group
Description:
Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion
Treatment:
Biological: CD20-directed CAR-T cells with CliniMACS Prodigy® system

Trial contacts and locations

1

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Central trial contact

Aibin Liang, MD,Ph.D.; Ping Li, MD,Ph.D.

Data sourced from clinicaltrials.gov

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