Clinical trial NCT04194931: Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
Official title: Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Keywords: Relapsed and refractory multiple myeloma; CAR-T
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.

Detailed description: CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18-70 years old
2. Estimated Survival time \> 12 weeks
3. Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
4. Chemotherapy failure or recurrent multiple myeloma
5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level
6. Bilirubin\<2.0mg/dl
7. Karnofsky Performance Status\>50% at the time of screening
8. Adequate pulmonary, renal, hepatic, and cardiac function
9. Fail in autologous haemopoietic stem cell transplantation
10. Not suitable for stem cell transplantation conditions or abandoned due to conditions
11. Free of leukocytes removal contraindications
12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent

Exclusion Criteria:

1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months
2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
3. The patient is an active hepatitis B or hepatitis C infection
4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
5. Abnormal vital signs
6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
8. General infection or local severe infection, or other infection that is not controlled
9. Dysfunction in lung, heart, kidney and brain
10. Severe autoimmune diseases
11. Other symptoms that are not applicable for CAR-T

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 2 year
measure: minimal residual disease（MRD）
timeFrame: 2 year
measure: Progression-free survival (PFS)
timeFrame: 2 year
measure: Overall survival (OS)
timeFrame: 2 year
Secondary outcomes:
measure: Safety (incidence of adverse events defined as dose-limited toxicity)
timeFrame: Study treatment until Week 24
measure: Expression of CD19 CART cells
timeFrame: 2 year
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nangchang University
state: Jiangxi
Study officials:
References: