NCT05243212

Study of CAR-BCMA, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma

Recruiting now Phase 1, PHASE2 Last updated 31 January 2024

What this trial tests

Phase 1, PHASE2 trial testing CAR-BCMA in Multiple Myeloma in 75 participants. Currently enrolling.

Timeline

19 September 2021

Primary endpoint
1 September 2024

1 September 2028

Quick facts

Lead sponsor	Sheba Medical Center
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	75
Start date	19 September 2021
Primary completion	1 September 2024
Estimated completion	1 September 2028
Sites	1 location across Israel

Drugs / interventions tested

• CAR-BCMA — full drug profile →

Conditions studied

• Multiple Myeloma — all drugs for Multiple Myeloma →
• Relapse Multiple Myeloma — all drugs for Relapse Multiple Myeloma →

Sponsor

Sheba Medical Center

Who can join

18 and older, any sex, with Multiple Myeloma or Relapse Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open label, abbreviated (3+3) dose escalation study in subjects with RRMM, followed by an extension phase at the selected safe dose. The dose escalation stage will involve recruitment of 3 RRMM patients for 'low' dose (6 x 106 CAR-T cells/kg) CAR-T therapy. After 14 days of follow-up for each of the 3 subjects, the DSC will determine whether the next subject can be recruited.

After 14 days follow-up for the 3rd subject, DSC will review data for the 3rd subject and consider the data for the first 3 subjects. In the absence of dose limiting toxicities (DLTs), the DSC may recommend recruitment of 3 subjects to be treated with the 'high' dose (9x106 CAR-T cells/kg) CAR-T therapy, with similar staggering. In case of DLTs in one of the 3 low dose subjects, the DSC may recommend to recruit an additional 3 low dose subjects (6 in total). If there are no additional DLTs in these 3 patients the low dose may be recommended by the DSC for the extension stage. However, further DLTs may prompt the DSC to recommend to modify the protocol, or to stop the study. In case of DLTs in one of the first 3 high dose subjects, the DSC may recommend to recruit an additional 3 high dose subjects.If there are no additional DLTs in these 3 patients, the high dose may be recommended by the DSC for the study extension stage. However, further DLTs may prompt the DSC to recommend continuation to the extension stage with the low dose, or to modify the protocol, or to stop the study.

After completion of two months follow-up for the 6th subject in the low or high dose cohort (as applicable), and review of all the data for all subjects, following DSC recommendations, the Stage 2 extension phase of the study may recruit additional subjects, up to a maximum of 75 subjects for Stages 1 and 2, combined.

DSC will review study data during the extension stage follow-up after 5 years to determine if additional safety follow-up is required.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting B Cell Maturation Antigen in Patients with Multiple Myeloma: Current Perspectives.
   Shrivastava T, Van Rhee F, Al Hadidi S. · · 2023 · cited 10× · PMID 37359353 · DOI 10.2147/ott.s370880
2. Are we there yet? CAR-T therapy in multiple myeloma.
   Mirvis E, Benjamin R. · · 2024 · cited 5× · PMID 39558776 · DOI 10.1111/bjh.19896
3. P889: POINT-OF-CARE ANTI-BCMA CAR T-CELL THERAPY INDUCES ENCOURAGING RESPONSE RATES IN HIGH-RISK RELAPSE/REFRACTORY MULTIPLE MYELOMA
   Magen H, Fried S, Itzhaki O, Shem-Tov N, et al · · 2023