Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05266768

Collaborator

Innovent Biologics (Suzhou) Co. Ltd. (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory Multiple Myeloma	Drug: IBI346	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open, Single-arm Clinical Study Evaluating the Safety and Efficacy of IBI346 Infusion in Relapsed/Refractory Multiple Myeloma

Anticipated Study Start Date :

Feb 28, 2022

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IBI346 Single arm	Drug: IBI346 IBI346 CAR-T cell injection by intravenous infusion

Arm

Intervention/Treatment

Experimental: IBI346

Single arm

Drug: IBI346

IBI346 CAR-T cell injection by intravenous infusion

Outcome Measures

Primary Outcome Measures

objective response rate(ORR) [up to Study 2 years]
duration of response(DoR) [up to Study 2 years]
time to response(TTR) [up to Study 2 years]
progression free survival(PFS) [up to Study 2 years]
overall survival(OS) [up to Study 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 and above, no gender limitation.
According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
Prior treatment of at least 3 lines of treatment, with at least 1 full treatment cycle for each line of treatment (unless the best recorded outcome is progressive disease (PD), according to IMWG criteria); Proteasome inhibitors and immunomodulators must be included.
Documented disease progression during or within 12 months of the most recent anti-myeloma treatment.
Determine the presence of measurable lesions during screening
ECOG score is 0 or 1.
Expected survival time ≥12 weeks.

Exclusion Criteria:

Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants.
Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
Prior BCMA targeted therapy.
No unmobilized mononuclear cells can be collected for CAR T cell production.
Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses < 10mg/ day).
Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hu Bei	China	430000

Sponsors and Collaborators

Huazhong University of Science and Technology
Innovent Biologics (Suzhou) Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jianfeng Zhou, Principal Investigator, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT05266768

Other Study ID Numbers:

CIBI346Y002

First Posted:

Mar 4, 2022

Last Update Posted:

Mar 4, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Mar 4, 2022