Overview

Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple Myeloma

Status:
Active, not recruiting
Trial end date:
2023-06-23
Target enrollment:
0
Participant gender:
All
Summary
A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborators:
CARsgen Therapeutics Co., Ltd.
Carsgen Therapeutics, Ltd.
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Criteria
Inclusion Criteria:

- Patients aged between 18 ~ 70 with relapsed or refractory multiple myeloma.

- Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological
examination.

- Patients with relapsed or refractory multiple myeloma who meet the following
conditions:

1. Curative efficacy is little or disease progressed after 2 courses of standard
treatment regimen;

2. Disease relapsed after chemotherapy or HSCT. Curative efficacy is little or
disease progressed after 2 courses of original treatment regimen;

3. More than 60 days between last treatment and disease progression;

4. Autologous or allogeneic SCT is not available at present, or patient refuses to
receive SCT;

5. No response to treatment is defined according to International Myeloma Working
Group 2014 version as not achieving CR (including CR, sCR, ICR, MCR) or PR
(including VGPR, PR, MR) after 2 consecutive cycles of treatment with current
therapy, and the interval between the 2 cycles is no more than 60 days. Disease
progression is defined as per 《Chinese Guidelines for Diagnosis and Treatment of
Multiple Myeloma》 (Revision in 2015). At least one of the following conditions
should be met:Serum M-protein increases ≥ 25% (absolute increase should be ≥ 5
g/L); If serum M protein is ≥ 50 g/L at baseline, increase of serum M protein can
be ≥ 10 g/L; Urine M-protein increases ≥ 25% (absolute increase should be ≥ 200
mg/24 h); If the serum and urine M-protein are not detectable, a ≥ 25% increase
in the difference between involved and uninvolved FLC levels is required
(absolute increase should be ≥ 100 mg/L); Bone marrow plasma cell percentage
increases ≥ 25% (absolute increase should be ≥ 10%); Size of existing bone
lesions or soft tissue plasmacytomas increases by ≥ 25%, or development of new
lytic bone lesions or soft tissue plasmacytomas; Development of hypercalcemia
that can be attributed to plasma cell proliferative disorder (corrected calcium
is > 2.8 mmol/L or 11.5 mg/dL); Disease progression must be confirmed by 2
sequential assessments.

- Expected survival > 12 weeks.

- Disease is measurable, and at least one of the following conditions should be
satisfied:

- Serum M-protein is ≥ 10 g/L;

- 24-hour urine M-protein is ≥ 200 mg;

- Serum FLC is ≥ 5 mg/dL;

- Plasmacytomas that can be evaluated by tests or imaging;

- Bone marrow plasma cell percentage is ≥ 20%.

- ECOG scores 0 - 1.

- Adequate venous access for apheresis and venous blood sampling, and no other
contraindications for leukapheresis.

- WBC ≥ 1.5×10^9/L;PLT ≥ 45×10^9/L; Hb≥9.0g/dL

- Serum creatinine ≤ 1.5 ULN.

- ALT ≤ 2.5 ULN;AST ≤ 2.5 ULN. The above lab results should not include those obtained
from continuous supportive treatment that is ongoing.

Exclusion Criteria:

Patients with any of the following conditions are not eligible for this study.

- Pregnant or lactating women.

- HIV positive, or HCV positive

- Uncontrolled active infection, including active tuberculosis and HBV DNA copies ≥
1×10^3 copies/mL.

- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not
exclusionary.

- Allergic to immunotherapies and related drugs.

- Patients with heart disease for which treatment is needed or with poorly controlled
hypertension.

- Hyponatremia: serum sodium level < 125 mmol/L.

- Baseline serum potassium < 3.5 mmol/L (taking potassium supplements before
participating in the study to raise potassium level is acceptable).

- Previous treatment with chemoradiotherapy, local treatment ,immunotherapy and
tumor-targeting drug conducted 2 weeks prior to participation in this study or blood
collection.

- Patients have undertaken immunosuppressor for graft-versus-host disease (GVHD) within
4 weeks before participation in this study or blood collection, or the patient is
diagnosed with acute or chronic GVHD.

- Other severe disease that may restrain patients from participating in this study (e.g.
diabetes, severe cardiac dysfunction, myocardial infarction or unstable arrhythmias or
unstable angina in recent 6 months, gastric ulcer, active autoimmune disease, etc.).