In-house dual CAR T-cell therapy development

Conditions: Multiple Myeloma
10018865

Registration Number: NL-OMON56725

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

• 18 years and older
• Be able to read, understand and give informed consent
• Have MM and belong to 1 of the following subgroups:
Group 1A: MM patients, triple refractory
Group 2A: MM patients, treated with BsAbs, either on treatment or within 3
months after discontinuation
Group 1B: MM patients having received first line treatment only
Group 1C: Newly diagnosed MM patients
Group 2B: MM patients > 3 months after BsAbs treatment discontinuation

• For the full scale experiment: the haemoglobin level should be > 6.5 mmol/L,
lower haemoglobin levels (5,0-6,5 mmol/L) are accepted when blood withdrawal is
combined with an already scheduled routine blood transfusion.

Exclusion Criteria

• not being able to give informed consent
• A lymphocyte count of < 0.5 x 10^9/L
• Use of corticosteroids > 20 mg a day in the 7 days before blood withdrawal.
The same counts for any other immunosuppressant drug
• Haemoglobin level < 5,0 mmol/L
• For the full scale experiment: any condition which may possibly interfere
with the safety of extra blood withdrawal.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We define effective production of CAR T-cells from patient blood as follows:<br /><br>- Minimum expansion of 5-fold.<br /><br>- >65% effective killing of myeloma cells<br /><br>- 15-50% T cell transduction with a GMP-grade retroviral vector<br /><br>- Viability of > 80 %<br /><br><br /><br>Successful: when >=4 out of 5 experiments per group meet these endpoints<br /><br>Unsuccessful: when <4 out of 5 experiments per group meet these endpoints</p><br>

Secondary Outcome Measures