Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCARsgen Therapeutics Co., Ltd.
About this trial
A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily signed consent;
Age of ≥ 18;
Willing and able to adhere to trial visit schedule and other protocol requirements
Received sufficient prior lines of therapy;
Disqualifiers
Any significant condition(s), laboratory abnormality or psychiatric illness that would impair the ability of the participant to receive or tolerate the planned treatment or in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Pregnant or lactating women;
HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
Any uncontrolled active infection;
Trial design
Design model
Sequential
Treatments tested in this trial
CT071
Biological/Vaccinea single CAR-T infusion of CT071
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Phase 1Experimental treatment 1 intervention
Group B: Phase 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD).
Frequency, type, and severity of AEs (SAEs, AESIs, laboratory abnormalities).
Time frame
Day 1 - Month 242
Phase 2: Objective response rate
Objective response rate (ORR) per IMWG by IRC read; percentage of participants achieving confirmed PR or better per IMWG 2016 consensus criteria.
Time frame
Day 1 - Month 24Secondary outcomes
1
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Overall Response Rate/Best Overall Response Rate by investigator (by IMWG stringent complete response/sCR, complete response/CR, very good partial response/VGPR, and partial response/PR by IRC and investigator assessment).
Time frame
Day 1 - Month 242
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Duration of Response by IMWG (stringent complete response/sCR, complete response/CR, very good partial response/VGPR, and partial response/PR by IRC and investigator assessment).
Time frame
Day 1 - Month 243
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Progression Free Survival by investigator assessment
Time frame
Day 1 - Month 244
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Overall Survival
Time frame
Day 1 - Month 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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